Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01073943
First received: February 22, 2010
Last updated: October 23, 2012
Last verified: October 2012
Results First Received: August 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bowel Preparation
Interventions: Drug: PicoPrep
Drug: HalfLytely
Drug: bisacodyl

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Participant Flow:   Overall Study
    PicoPrep     HalfLytely  
STARTED     300     303  
Safety Population (Treated)     296     302  
Intent to Treat Population     294 [1]   300 [1]
COMPLETED     287     295  
NOT COMPLETED     13     8  
Withdrawal by Subject                 8                 2  
Protocol Violation                 2                 1  
Adverse Event                 1                 1  
Lost to Follow-up                 0                 2  
Power outage; colonoscopy not done                 1                 0  
Subject forgot                 0                 1  
Unable to return for follow-up                 0                 1  
Could not tolerate prep                 1                 0  
[1] Two treated participants did not have an efficacy assessment performed.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Total Total of all reporting groups

Baseline Measures
    PicoPrep     HalfLytely     Total  
Number of Participants  
[units: participants]
  296     302     598  
Age  
[units: years]
Mean ± Standard Deviation
  56.8  ± 9.66     56.2  ± 10.11     56.5  ± 9.89  
Gender  
[units: participants]
     
Female     192     189     381  
Male     104     113     217  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     8     15     23  
Not Hispanic or Latino     288     287     575  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     22     32     54  
White     274     268     542  
Other     0     0     0  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation
  29.185  ± 5.3209     29.541  ± 6.1688     29.365  ± 5.7634  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist   [ Time Frame: Day 2 ]

Measure Type Primary
Measure Title Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist
Measure Description Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.
Time Frame Day 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population of randomized and treated participants with efficacy assessments performed.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Measured Values
    PicoPrep     HalfLytely  
Number of Participants Analyzed  
[units: participants]
  294     300  
Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist  
[units: percentage of participants]
  83.0     79.7  


Statistical Analysis 1 for Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Mean Difference (Net) [3] 3.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was >-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was >0%.
[3] Other relevant estimation information:
  No text entered.



2.  Secondary:   Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist   [ Time Frame: Day 2 ]

Measure Type Secondary
Measure Title Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Measure Description Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.
Time Frame Day 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population of randomized and treated participants with efficacy assessments performed.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Measured Values
    PicoPrep     HalfLytely  
Number of Participants Analyzed  
[units: participants]
  294     300  
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist  
[units: percentage of participants]
  81.3     84.0  


Statistical Analysis 1 for Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Mean Difference (Net) [3] -2.7
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.
[3] Other relevant estimation information:
  No text entered.



3.  Secondary:   Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?   [ Time Frame: Day 2 ]

Measure Type Secondary
Measure Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?
Measure Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult
Time Frame Day 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Measured Values
    PicoPrep     HalfLytely  
Number of Participants Analyzed  
[units: participants]
  293     298  
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?  
[units: percentage of participants]
   
Very easy     58.4     16.1  
Easy     29.0     21.1  
Tolerable     11.6     45.3  
Difficult     1.0     11.7  
Very difficult     0     5.7  


Statistical Analysis 1 for Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



4.  Secondary:   Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?   [ Time Frame: Day 2 ]

Measure Type Secondary
Measure Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?
Measure Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
Time Frame Day 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Measured Values
    PicoPrep     HalfLytely  
Number of Participants Analyzed  
[units: participants]
  293     298  
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?  
[units: percentage of participants]
   
Yes     99.7     92.3  
No     0.3     7.7  


Statistical Analysis 1 for Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Secondary:   Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation   [ Time Frame: Day 2 ]

Measure Type Secondary
Measure Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
Measure Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad
Time Frame Day 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Measured Values
    PicoPrep     HalfLytely  
Number of Participants Analyzed  
[units: participants]
  292     298  
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation  
[units: percentage of participants]
   
Excellent     45.5     19.1  
Good     43.8     48.7  
Fair     9.2     25.5  
Poor     0.7     3.4  
Bad     0.7     3.4  


Statistical Analysis 1 for Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



6.  Secondary:   Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was   [ Time Frame: Day 2 ]

Measure Type Secondary
Measure Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was
Measure Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad
Time Frame Day 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Measured Values
    PicoPrep     HalfLytely  
Number of Participants Analyzed  
[units: participants]
  293     298  
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was  
[units: percentage of participants]
   
Excellent     25.6     4.0  
Good     48.1     23.8  
Tolerable     23.9     52.3  
Poor     1.7     12.1  
Bad     0.7     7.7  


Statistical Analysis 1 for Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



7.  Secondary:   Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?   [ Time Frame: Day 2 ]

Measure Type Secondary
Measure Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?
Measure Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
Time Frame Day 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Measured Values
    PicoPrep     HalfLytely  
Number of Participants Analyzed  
[units: participants]
  293     298  
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?  
[units: percentage of participants]
   
Yes     93.2     59.4  
No     6.8     40.6  


Statistical Analysis 1 for Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



8.  Secondary:   Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?   [ Time Frame: Day 2 ]

Measure Type Secondary
Measure Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?
Measure Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
Time Frame Day 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Measured Values
    PicoPrep     HalfLytely  
Number of Participants Analyzed  
[units: participants]
  293     298  
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?  
[units: percentage of participants]
   
Yes     4.8     14.4  
No     95.2     85.6  


Statistical Analysis 1 for Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



9.  Secondary:   Participants With Treatment-Emergent Adverse Events (TEAEs)   [ Time Frame: up to one month ]

Measure Type Secondary
Measure Title Participants With Treatment-Emergent Adverse Events (TEAEs)
Measure Description Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.
Time Frame up to one month  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population of participants who were treated.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Measured Values
    PicoPrep     HalfLytely  
Number of Participants Analyzed  
[units: participants]
  296     302  
Participants With Treatment-Emergent Adverse Events (TEAEs)  
[units: participants]
   
Any TEAE     218     241  
Deaths     0     0  
Serious AE     2     1  
TEAEs leading to discontinuation of study drug     0     1  
Severe TEAEs     5     6  
Related TEAEs     33     29  

No statistical analysis provided for Participants With Treatment-Emergent Adverse Events (TEAEs)



10.  Other Pre-specified:   Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist   [ Time Frame: Day 2 ]

Measure Type Other Pre-specified
Measure Title Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Measure Description Colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. See Outcome #2 for definitions of the scale. Assessment of mid colon, recto-sigmoid, and overall (ascending, mid, and recto-sigmoid) cleansing is summarized here.
Time Frame Day 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population of randomized and treated participants with efficacy assessments performed.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Measured Values
    PicoPrep     HalfLytely  
Number of Participants Analyzed  
[units: participants]
  294     300  
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist  
[units: percentage of participants]
   
Mid-colon     93.2     88.7  
Recto-sigmoid colon     92.2     89.0  
Overall: ascending, mid, and recto-sigmoid colon     78.9     78.0  


Statistical Analysis 1 for Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Mean Difference (Net) [3] 4.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Mid colon comparison
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Mean Difference (Net) [3] 3.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Recto-sigmoid colon comparison
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Mean Difference (Net) [3] 0.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Overall comparison: ascending colon, mid colon and recto-sigmoid colon
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.
[3] Other relevant estimation information:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information