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Trial record 58 of 10864 for:    Placebo AND once

Dulcolax vs Placebo in Functional Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00526097
Recruitment Status : Completed
First Posted : September 6, 2007
Results First Posted : August 6, 2010
Last Update Posted : January 15, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Constipation
Interventions Drug: Bisacodyl 10 mg
Drug: Placebo
Enrollment 368
Recruitment Details Participants were partly recruited by commercial research centers and partly by general practitioners.
Pre-assignment Details Participants were randomised into the treatment period only, when functional constipation and compliance with rescue medication were confirmed by eDiary data in the two-weeks baseline period without study medication.
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description Two bisacodyl-matching 5 mg placebo tablets once daily Two bisacodyl 5 mg tablets once daily
Period Title: Overall Study
Started 121 [1] 247 [1]
Completed 106 [2] 191 [2]
Not Completed 15 56
Reason Not Completed
Adverse Event             6             44
Protocol Violation             4             10
Withdrawal by Subject             3             1
Other             2             1
[1]
Started: Participant was randomised and took at least one dose of randomised study medication
[2]
Completed: Participant without premature discontinuation in the randomised treatment period
Arm/Group Title Placebo Bisacodyl Total
Hide Arm/Group Description Two bisacodyl-matching 5 mg placebo tablets once daily Two bisacodyl 5 mg tablets once daily Total of all reporting groups
Overall Number of Baseline Participants 121 247 368
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 247 participants 368 participants
54.7  (15.1) 55.8  (15.9) 55.4  (15.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 247 participants 368 participants
Female
96
  79.3%
179
  72.5%
275
  74.7%
Male
25
  20.7%
68
  27.5%
93
  25.3%
Baseline assessment regarding the bothersomeness with abdominal bloating   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 121 participants 247 participants 368 participants
Not at all bothersome 12 21 33
Hardly bothersome 20 33 53
Moderately bothersome 40 85 125
A good deal bothersome 36 60 96
A very great deal bothersome 12 47 59
Missing assessment 1 1 2
[1]
Measure Description: Baseline assessment was made at the end of the last week of the baseline period without study medication using a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome)
Baseline assessment regarding the bothersomeness with abdominal discomfort   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 121 participants 247 participants 368 participants
Not at all bothersome 14 26 40
Hardly bothersome 22 40 62
Moderately bothersome 47 91 138
A good deal bothersome 31 64 95
A very great deal bothersome 6 25 31
Missing assessment 1 1 2
[1]
Measure Description: Baseline assessment was made at the end of the last week of the baseline period without study medication using a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome)
Baseline assessment regarding the bothersomeness with constipation   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 121 participants 247 participants 368 participants
Not at all bothersome 6 15 21
Hardly bothersome 5 19 24
Moderately bothersome 57 91 148
A good deal bothersome 41 88 129
A very great deal bothersome 11 33 44
Missing assessment 1 1 2
[1]
Measure Description: Baseline assessment was made at the end of the last week of the baseline period without study medication using a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome)
Baseline assessment regarding the overall satisfaction with bowel habits   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 121 participants 247 participants 368 participants
A very great deal satisfied 3 10 13
A good deal satisfied 3 9 12
Moderately satisfied 41 74 115
Hardly satisfied 44 93 137
Not at all satisfied 29 60 89
Missing assessment 1 1 2
[1]
Measure Description: Baseline assessment was made at the end of the last week of the baseline period without study medication using a 5-point ordinal verbal rating scale (VRS): 0 (A very great deal satisfied) to 4 (Not at all satisfied)
Baseline for dimension 'Bodily pain (BP)' of the SF-36 QoL scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
68.5  (24.3) 67.5  (26.0) 67.8  (25.4)
[1]
Measure Description: The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Baseline for dimension 'General health (GH)' of the SF-36 QoL scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
68.0  (21.1) 69.9  (20.6) 69.3  (20.7)
[1]
Measure Description: The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. (Placebo: N=119, Bisacodyl: N=245)
Baseline for dimension 'Mental health (MH)' of the SF-36 QoL scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
74.2  (18.0) 77.0  (16.8) 76.1  (17.2)
[1]
Measure Description: The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Baseline for dimension 'Physical functioning (PF)' of the SF-36v2™ (SF-36) Quality of Life (QoL)   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
79.2  (24.3) 80.1  (24.6) 79.8  (24.5)
[1]
Measure Description: The dimension is a sum of 10 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Baseline for dimension 'Role limitation due to emotional problems (RE)' of the SF-36 QoL scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
82.7  (24.7) 86.3  (22.3) 85.1  (23.1)
[1]
Measure Description: The dimension is a sum of 3 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Baseline for dimension 'Role limitation due to physical problems (RP)' of the SF-36 QoL scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
79.7  (25.2) 80.6  (25.6) 80.3  (25.5)
[1]
Measure Description: The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Baseline for dimension 'Social functioning (SF)' of the SF-36 QoL scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
83.4  (21.6) 86.0  (20.9) 85.1  (21.2)
[1]
Measure Description: The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Baseline for dimension 'Vitality (VT)' of the SF-36 QoL scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
55.7  (20.2) 58.9  (21.0) 57.9  (20.8)
[1]
Measure Description: The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Baseline for the Mental Component Scale (MCS) of the SF-36 QoL scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
49.0  (11.0) 51.1  (9.8) 50.4  (10.3)
[1]
Measure Description: The MCS is a summary scale of the dimensions vitality, social functioning, role-emotional, and mental health. The component scale is norm-based to a standard population. A higher score indicates a better health. (Placebo: N=119, Bisacodyl: N=245)
Baseline for the Physical Component Scale (PCS) of the SF-36 QoL scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
48.7  (9.4) 48.3  (9.8) 48.5  (9.7)
[1]
Measure Description: The PCS is a summary scale of the subscales physical functioning, role-physical, bodily pain, and general health. The component scale is norm-based to a standard population. A higher score indicates a better health. (Placebo: N=119, Bisacodyl: N=245)
Baseline mean score for constipation symptom 'Sensation of incomplete evacuation'   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
0.7  (0.3) 0.7  (0.3) 0.7  (0.3)
[1]
Measure Description: The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the last week of the baseline period without study medication (Placebo: N=120, Bisacodyl: N=240).
Baseline mean score for constipation symptom 'Manual manoeuvre'   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
0.2  (0.4) 0.2  (0.3) 0.2  (0.3)
[1]
Measure Description: The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the last week of the baseline period without study medication (Placebo: N=116, Bisacodyl: N=231).
Baseline mean score for constipation symptom 'Anorectal obstructions/blockade'   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
1.2  (1.0) 1.2  (1.0) 1.2  (1.0)
[1]
Measure Description: The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the last week of the baseline period without study medication. (Placebo: N=116, Bisacodyl: N=231)
Baseline mean score for constipation symptom 'Stool quality'   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
2.4  (1.2) 2.5  (1.3) 2.4  (1.3)
[1]
Measure Description: The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the last week of the baseline period without study medication. (Placebo: N=116, Bisacodyl: N=231)
Baseline mean score for constipation symptom 'Straining'   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
1.9  (0.9) 1.8  (0.8) 1.9  (0.8)
[1]
Measure Description: The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the last week of the baseline period without study medication. (Placebo: N=116, Bisacodyl: N=231)
Baseline number of Complete Spontaneous Bowel Movements (CSBMs)   [1] 
Mean (Standard Deviation)
Unit of measure:  CSBMs per week
Number Analyzed 121 participants 247 participants 368 participants
1.0  (1.1) 1.1  (1.2) 1.1  (1.2)
[1]
Measure Description: Complete Spontaneous Bowel Movement (CSBM): complete non-rescue medication-induced BM; Baseline number of CSBMs is defined by the number of CSBMs during the last week of the baseline period without study medication
Baseline number of Spontaneous Bowel Movements (SBMs)   [1] 
Mean (Standard Deviation)
Unit of measure:  SBMs per week
Number Analyzed 121 participants 247 participants 368 participants
4.2  (2.6) 4.4  (3.9) 4.3  (3.6)
[1]
Measure Description: Spontaneous BM (SBM): non-rescue medication-induced BM; Baseline number of SBMs is defined by the number of SBMs during the last week of the baseline period without study medication
Baseline overall score (OSC) of PAC-QoL   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
1.8  (0.6) 1.8  (0.7) 1.8  (0.7)
[1]
Measure Description: The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL (Placebo: N=119, Bisacodyl: N=245)
Baseline subscore 'Physical discomfort (PHD)' of PAC-QoL   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
1.9  (0.8) 2.0  (0.9) 2.0  (0.9)
[1]
Measure Description: The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL (Placebo: N=120, Bisacodyl: N=245)
Baseline subscore 'Psychosocial discomfort (PSD)' of PAC-QoL   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
0.8  (0.8) 0.9  (0.8) 0.9  (0.8)
[1]
Measure Description: The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL (Placebo: N=121, Bisacodyl: N=245)
Baseline subscore 'Satisfaction (SAT)' of PAC-QoL   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
3.0  (0.7) 2.8  (0.8) 2.9  (0.8)
[1]
Measure Description: The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL (Placebo: N=120, Bisacodyl: N=245)
Baseline subscore'Worries and concerns (WCC)' of Patient Assessment of Constipation-QoL(PAC-QoL)   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 247 participants 368 participants
1.4  (0.8) 1.5  (0.9) 1.4  (0.9)
[1]
Measure Description: The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL (Placebo: N=121, Bisacodyl: N=245)
Baseline value for chloride (normalized value)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 121 participants 247 participants 368 participants
104.0  (2.33) 103.7  (2.85) 103.8  (2.69)
[1]
Measure Description: Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range (Placebo: N=120, Bisacodyl: N=245)
Baseline value for potassium (normalized value)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 121 participants 247 participants 368 participants
4.2  (0.33) 4.2  (0.33) 4.2  (0.33)
[1]
Measure Description: Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range (Placebo: N=120, Bisacodyl: N=244)
Baseline value for sodium (normalized value)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 121 participants 247 participants 368 participants
139.5  (2.13) 139.3  (2.30) 139.4  (2.24)
[1]
Measure Description: Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range (Placebo: N=120, Bisacodyl: N=245)
1.Primary Outcome
Title Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period
Hide Description

A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool.

The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.

Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 117 239
Least Squares Mean (Standard Error)
Unit of Measure: CSBMs per week
1.9  (0.34) 5.2  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.3
Confidence Interval 95%
2.6 to 4.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.36
Estimation Comments Means are adjusted for center effects and baseline value
2.Secondary Outcome
Title Number of CSBMs at Week 1
Hide Description The number of CSBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time Frame Week 1 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 117 239
Least Squares Mean (Standard Error)
Unit of Measure: CSBMs per week
2.0  (0.40) 6.3  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.3
Confidence Interval 95%
3.5 to 5.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.42
Estimation Comments Means are adjusted for center effects and baseline value
3.Secondary Outcome
Title Number of CSBMs at Week 2
Hide Description The number of CSBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time Frame Week 2 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 115 229
Least Squares Mean (Standard Error)
Unit of Measure: CSBMs per week
1.4  (0.41) 4.9  (0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.5
Confidence Interval 95%
2.7 to 4.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.43
Estimation Comments Means are adjusted for center effects and baseline value
4.Secondary Outcome
Title Number of CSBMs at Week 3
Hide Description The number of CSBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time Frame Week 3 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 113 213
Least Squares Mean (Standard Error)
Unit of Measure: CSBMs per week
1.8  (0.38) 4.6  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.8
Confidence Interval 95%
2.0 to 3.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.39
Estimation Comments Means are adjusted for center effects and baseline value
5.Secondary Outcome
Title Number of CSBMs at Week 4
Hide Description The number of CSBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time Frame Week 4 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 196
Least Squares Mean (Standard Error)
Unit of Measure: CSBMs per week
1.7  (0.42) 4.3  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.6
Confidence Interval 95%
1.8 to 3.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.43
Estimation Comments Means are adjusted for center effects and baseline value
6.Secondary Outcome
Title Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period
Hide Description A Spontaneous Bowel Movement (SBM) is a non-rescue medication-induced stool. The number of SBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 117 239
Least Squares Mean (Standard Error)
Unit of Measure: SBMs per week
5.1  (0.41) 10.0  (0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.9
Confidence Interval 95%
4.1 to 5.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.43
Estimation Comments Means are adjusted for center effects and baseline value
7.Secondary Outcome
Title Number of SBMs at Week 1
Hide Description The number of SBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time Frame Week 1 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 117 239
Least Squares Mean (Standard Error)
Unit of Measure: SBMs per week
5.3  (0.46) 12.1  (0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.7
Confidence Interval 95%
5.8 to 7.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.49
Estimation Comments Means are adjusted for center effects and baseline value
8.Secondary Outcome
Title Number of SBMs at Week 2
Hide Description The number of SBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time Frame Week 2 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 115 229
Least Squares Mean (Standard Error)
Unit of Measure: SBMs per week
4.9  (0.44) 9.6  (0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.7
Confidence Interval 95%
3.8 to 5.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.46
Estimation Comments Means are adjusted for center effects and baseline value
9.Secondary Outcome
Title Number of SBMs at Week 3
Hide Description The number of SBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time Frame Week 3 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 113 213
Least Squares Mean (Standard Error)
Unit of Measure: SBMs per week
4.8  (0.44) 8.6  (0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.8
Confidence Interval 95%
2.9 to 4.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.45
Estimation Comments Means are adjusted for center effects and baseline value
10.Secondary Outcome
Title Number of SBMs at Week 4
Hide Description The number of SBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time Frame Week 4 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 196
Least Squares Mean (Standard Error)
Unit of Measure: SBMs per week
4.0  (0.42) 7.8  (0.36)
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Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.7
Confidence Interval 95%
2.9 to 4.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.43
Estimation Comments Means are adjusted for center effects and baseline value
11.Secondary Outcome
Title Time to the First SBM Following the First Dose of Study Medication (SM)
Hide Description The time to the first SBM following the first dose of SM was captured by the eDiary. The time was censored by the time of intake of rescue medication (RM), the time of premature discontinuation or the end of treatment whatever was minimal.
Time Frame Time of first dose of SM up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 114 235
Median (95% Confidence Interval)
Unit of Measure: Hours
19
(16 to 25)
12
(11 to 12)
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Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments The log-rank test was used to calculate the p-value and to test for differences between the treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline
Hide Description [Not Specified]
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 117 239
Measure Type: Number
Unit of Measure: Participants
47 196
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Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.04
Confidence Interval 95%
1.62 to 2.57
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
13.Secondary Outcome
Title Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline
Hide Description [Not Specified]
Time Frame Baseline and week 1 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 117 239
Measure Type: Number
Unit of Measure: Participants
57 204
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.75
Confidence Interval 95%
1.44 to 2.13
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
14.Secondary Outcome
Title Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline
Hide Description [Not Specified]
Time Frame Baseline and week 2 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 115 229
Measure Type: Number
Unit of Measure: Participants
43 178
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.08
Confidence Interval 95%
1.62 to 2.66
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
15.Secondary Outcome
Title Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline
Hide Description [Not Specified]
Time Frame Baseline and week 3 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 113 213
Measure Type: Number
Unit of Measure: Participants
51 163
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.70
Confidence Interval 95%
1.37 to 2.11
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
16.Secondary Outcome
Title Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline
Hide Description [Not Specified]
Time Frame Baseline and week 4 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 196
Measure Type: Number
Unit of Measure: Participants
52 148
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.52
Confidence Interval 95%
1.24 to 1.88
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
17.Secondary Outcome
Title Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 117 239
Measure Type: Number
Unit of Measure: Participants
2 70
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 17.13
Confidence Interval 95%
4.28 to 68.66
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
18.Secondary Outcome
Title Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 117 239
Measure Type: Number
Unit of Measure: Participants
32 161
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.46
Confidence Interval 95%
1.81 to 3.35
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
19.Secondary Outcome
Title Number of Premature Withdrawals Over the 4 Weeks Treatment Period
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 117 239
Measure Type: Number
Unit of Measure: Participants
10 51
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0025
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.50
Confidence Interval 95%
1.32 to 4.74
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
20.Secondary Outcome
Title Number of Premature Withdrawals at Week 1 in the Treatment Period
Hide Description [Not Specified]
Time Frame Week 1 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 117 239
Measure Type: Number
Unit of Measure: Participants
3 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0105
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.08
Confidence Interval 95%
1.26 to 13.24
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
21.Secondary Outcome
Title Number of Premature Withdrawals at Week 2 in the Treatment Period
Hide Description [Not Specified]
Time Frame Week 2 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 115 229
Measure Type: Number
Unit of Measure: Participants
3 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.84
Confidence Interval 95%
0.52 to 6.47
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
22.Secondary Outcome
Title Number of Premature Withdrawals at Week 3 in the Treatment Period
Hide Description [Not Specified]
Time Frame Week 3 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 113 214
Measure Type: Number
Unit of Measure: Participants
4 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval 95%
0.37 to 3.77
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
23.Secondary Outcome
Title Number of Premature Withdrawals at Week 4 in the Treatment Period
Hide Description [Not Specified]
Time Frame Week 4 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 196
Measure Type: Number
Unit of Measure: Participants
0 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0951
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
24.Secondary Outcome
Title Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 117 239
Measure Type: Number
Unit of Measure: Participants
21 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.19
Confidence Interval 95%
0.09 to 0.41
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
25.Secondary Outcome
Title Number of Participants Using Rescue Medication at Week 1 in the Treatment Period
Hide Description [Not Specified]
Time Frame Week 1 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 117 239
Measure Type: Number
Unit of Measure: Participants
2 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2524
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.24
Confidence Interval 95%
0.02 to 2.67
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
26.Secondary Outcome
Title Number of Participants Using Rescue Medication at Week 2 in the Treatment Period
Hide Description [Not Specified]
Time Frame Week 2 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 115 229
Measure Type: Number
Unit of Measure: Participants
10 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.20
Confidence Interval 95%
0.06 to 0.63
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
27.Secondary Outcome
Title Number of Participants Using Rescue Medication at Week 3 in the Treatment Period
Hide Description [Not Specified]
Time Frame Week 3 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 113 213
Measure Type: Number
Unit of Measure: Participants
9 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.06
Confidence Interval 95%
0.01 to 0.46
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
28.Secondary Outcome
Title Number of Participants Using Rescue Medication at Week 4 in the Treatment Period
Hide Description [Not Specified]
Time Frame Week 4 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 196
Measure Type: Number
Unit of Measure: Participants
12 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0086
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.27
Confidence Interval 95%
0.10 to 0.69
Estimation Comments OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented
29.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1
Hide Description The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 1 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 222
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.3  (0.08) -1.3  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval 95%
-1.2 to -0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments Means are adjusted for center effects and baseline value
30.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2
Hide Description The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 2 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 204
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.1  (0.09) -1.1  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval 95%
-1.2 to -0.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments Means are adjusted for center effects and baseline value
31.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3
Hide Description The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 3 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 100 190
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.3  (0.09) -1.3  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval 95%
-1.1 to -0.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Means are adjusted for center effects and baseline value
32.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4
Hide Description The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 4 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 96 178
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.5  (0.10) -1.2  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval 95%
-0.9 to -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Means are adjusted for center effects and baseline value
33.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1
Hide Description The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 1 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 222
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
0.4  (0.13) 3.0  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.6
Confidence Interval 95%
2.4 to 2.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments Means are adjusted for center effects and baseline value
34.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2
Hide Description The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 2 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 204
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
0.2  (0.15) 2.7  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.4
Confidence Interval 95%
2.1 to 2.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments Means are adjusted for center effects and baseline value
35.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3
Hide Description The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 3 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 100 190
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
0.5  (0.14) 2.8  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.3
Confidence Interval 95%
2.0 to 2.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments Means are adjusted for center effects and baseline value
36.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4
Hide Description The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 4 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 96 178
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
0.6  (0.16) 2.6  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.0
Confidence Interval 95%
1.7 to 2.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments Means are adjusted for center effects and baseline value
37.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1
Hide Description The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 1 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 115 232
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.0  (0.05) -0.2  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval 95%
-0.3 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments Means are adjusted for center effects and baseline value
38.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2
Hide Description The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 2 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 113 220
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.0  (0.05) -0.2  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval 95%
-0.3 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments Means are adjusted for center effects and baseline value
39.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3
Hide Description The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 3 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 107 201
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.1  (0.05) -0.2  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0127
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval 95%
-0.2 to -0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments Means are adjusted for center effects and baseline value
40.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4
Hide Description The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 4 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 104 188
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.1  (0.06) -0.2  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0064
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval 95%
-0.3 to -0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments Means are adjusted for center effects and baseline value
41.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1
Hide Description The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 1 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 222
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.1  (0.08) -0.9  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval 95%
-0.9 to -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments Means are adjusted for center effects and baseline value
42.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2
Hide Description The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 2 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 204
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.1  (0.09) -0.9  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval 95%
-1.0 to -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments Means are adjusted for center effects and baseline value
43.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3
Hide Description The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 3 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 100 190
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.1  (0.08) -0.9  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval 95%
-0.9 to -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments Means are adjusted for center effects and baseline value
44.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4
Hide Description The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 4 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 96 178
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.1  (0.09) -0.8  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval 95%
-0.8 to -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments Means are adjusted for center effects and baseline value
45.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1
Hide Description The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 1 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 222
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.0  (0.03) -0.2  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval 95%
-0.2 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments Means are adjusted for center effects and baseline value
46.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2
Hide Description The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 2 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 105 204
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
0.0  (0.04) -0.2  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval 95%
-0.3 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.04
Estimation Comments Means are adjusted for center effects and baseline value
47.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3
Hide Description The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 3 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 100 190
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.0  (0.03) -0.2  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval 95%
-0.2 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.04
Estimation Comments Means are adjusted for center effects and baseline value
48.Secondary Outcome
Title Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4
Hide Description The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time Frame Baseline and week 4 in treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 96 178
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.1  (0.04) -0.2  (0.03)
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Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval 95%
-0.2 to -0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.04
Estimation Comments Means are adjusted for center effects and baseline value
49.Secondary Outcome
Title Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline
Hide Description Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline
Time Frame Baseline and week 1 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 112 224
Measure Type: Number
Unit of Measure: Participants
Improved overall satisfaction 44 153
Unchanged overall satisfaction 46 45
Worsened overall satisfaction 22 26
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Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for baseline
50.Secondary Outcome
Title Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline
Hide Description Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline
Time Frame Baseline and week 2 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 111 212
Measure Type: Number
Unit of Measure: Participants
Improved overall satisfaction 41 163
Unchanged overall satisfaction 48 37
Worsened overall satisfaction 22 12
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Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for baseline
51.Secondary Outcome
Title Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline
Hide Description Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline
Time Frame Baseline and week 3 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 104 195
Measure Type: Number
Unit of Measure: Participants
Improved overall satisfaction 44 153
Unchanged overall satisfaction 43 31
Worsened overall satisfaction 17 11
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Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for baseline
52.Secondary Outcome
Title Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline
Hide Description Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline
Time Frame Baseline and week 4 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 98 175
Measure Type: Number
Unit of Measure: Participants
Improved overall satisfaction 37 135
Unchanged overall satisfaction 47 32
Worsened overall satisfaction 14 8
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Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for baseline
53.Secondary Outcome
Title Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline
Hide Description Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time Frame Baseline and week 1 in the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:
Two bisacodyl-matching 5 mg placebo tablets once daily
Two bisacodyl 5 mg tablets once daily
Overall Number of Participants Analyzed 112 224
Measure Type: Number
Unit of Measure: Participants
Reduced bothersomeness 36 168
Unchanged bothersomeness 51 46
Increased bothersomeness 25 10
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Statistical Analysis Overview Comparison Group Selection Placebo, Bisacodyl