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Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C) (IBS-C)

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ClinicalTrials.gov Identifier: NCT02493452
Recruitment Status : Completed
First Posted : July 9, 2015
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Irritable Bowel Syndrome Characterized by Constipation
Interventions Drug: Plecanatide
Drug: Placebo
Enrollment 1135
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Hide Arm/Group Description Placebo Tablets dosed once daily for 12 weeks Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
Period Title: Overall Study
Started 379 377 379
Completed 329 328 325
Not Completed 50 49 54
Arm/Group Title Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide Total
Hide Arm/Group Description Placebo Tablets dosed once daily for 12 weeks Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 379 377 379 1135
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 379 participants 377 participants 379 participants 1135 participants
44.8  (14.68) 44.0  (14.61) 43.1  (14.20) 44.0  (14.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 379 participants 377 participants 379 participants 1135 participants
Female
272
  71.8%
270
  71.6%
273
  72.0%
815
  71.8%
Male
107
  28.2%
107
  28.4%
106
  28.0%
320
  28.2%
1.Primary Outcome
Title Number of Overall Responders - ITT Population
Hide Description An Overall Responder was a patient who was a weekly responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least 1 complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Hide Arm/Group Description:
Placebo Tablets dosed once daily for 12 weeks
Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
Overall Number of Participants Analyzed 379 377 379
Measure Type: Count of Participants
Unit of Measure: Participants
54
  14.2%
81
  21.5%
91
  24.0%
2.Primary Outcome
Title Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks
Hide Description An Abdominal Pain Intensity Responder was a patient who had a decrease of 30 % from baseline for abdominal pain intensity. Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Hide Arm/Group Description:
Placebo Tablets dosed once daily for 12 weeks
Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
Overall Number of Participants Analyzed 379 377 379
Measure Type: Count of Participants
Unit of Measure: Participants
88
  23.2%
123
  32.6%
129
  34.0%
3.Primary Outcome
Title Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks
Hide Description A Stool Frequency Responder was a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Hide Arm/Group Description:
Placebo Tablets dosed once daily for 12 weeks
Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
Overall Number of Participants Analyzed 379 377 379
Measure Type: Count of Participants
Unit of Measure: Participants
106
  28.0%
129
  34.2%
148
  39.1%
4.Secondary Outcome
Title Number of Sustained Efficacy Responders
Hide Description A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Hide Arm/Group Description:
Placebo Tablets dosed once daily for 12 weeks
Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
Overall Number of Participants Analyzed 379 377 379
Measure Type: Count of Participants
Unit of Measure: Participants
53
  14.0%
78
  20.7%
90
  23.7%
5.Secondary Outcome
Title Change From Baseline in Stool Consistency
Hide Description

Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS). Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7:

  1. Separate hard lumps, like nuts (hard to pass)
  2. Sausage-shaped but lumpy
  3. Like a sausage but with cracks on its surface
  4. Like a sausage or snake, smooth and soft
  5. Soft blobs with clear-cut edges (passed easily)
  6. Fluffy pieces with ragged edges, a mushy stool
  7. Watery, no solid pieces, entirely liquid
Time Frame Baseline and 12-Week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Hide Arm/Group Description:
Placebo Tablets dosed once daily for 12 weeks
Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
Overall Number of Participants Analyzed 379 377 379
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 1.99  (1.029) 1.91  (0.902) 1.86  (0.912)
Week 12 change from baseline 1.04  (1.579) 1.55  (1.631) 1.45  (1.621)
6.Secondary Outcome
Title Change From Baseline in Straining
Hide Description Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining).
Time Frame Baseline and 12-Week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Hide Arm/Group Description:
Placebo Tablets dosed once daily for 12 weeks
Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
Overall Number of Participants Analyzed 379 377 379
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 6.75  (1.848) 6.84  (1.860) 6.87  (1.920)
Week 12 change from baseline -1.66  (2.149) -2.35  (2.540) -2.35  (2.556)
7.Secondary Outcome
Title Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement
Hide Description Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Time Frame Baseline and 12-Week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Hide Arm/Group Description:
Placebo Tablets dosed once daily for 12 weeks
Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
Overall Number of Participants Analyzed 376 375 379
Mean (Standard Deviation)
Unit of Measure: CSBMs per week
Baseline 0.24  (0.465) 0.26  (0.530) 0.27  (0.527)
Week 12 change from baseline 0.80  (1.779) 1.23  (2.303) 1.63  (3.042)
8.Secondary Outcome
Title Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication
Hide Description A responder was any patient with a SBM within 24 hours after the first dose of study drug.
Time Frame Up to 24 hours after the first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Hide Arm/Group Description:
Placebo Tablets dosed once daily for 12 weeks
Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
Overall Number of Participants Analyzed 379 377 379
Measure Type: Count of Participants
Unit of Measure: Participants
119
  31.4%
157
  41.6%
167
  44.1%
9.Secondary Outcome
Title Change From Baseline in Abdominal Pain
Hide Description Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (None) to 10 (Worst Possible). Baseline was the mean of the non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The average daily abdominal pain score was the average of the non-missing worst daily abdominal pain scores (on a 0 to 10 scale) in the given week.
Time Frame Baseline and 12-Week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Hide Arm/Group Description:
Placebo Tablets dosed once daily for 12 weeks
Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
Overall Number of Participants Analyzed 379 377 379
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 6.40  (1.624) 6.56  (1.634) 6.48  (1.714)
Week 12 change from baseline -1.42  (2.116) -2.00  (2.226) -1.87  (2.297)
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population consisted of 1130 patients who had received at least one dose of the study drug. A total of 1135 patients were randomized and five randomized patients did not receive study drug after being randomized in the study.
 
Arm/Group Title Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Hide Arm/Group Description Placebo Tablets dosed once daily for 12 weeks Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
All-Cause Mortality
Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/376 (0.27%)      2/375 (0.53%)      3/379 (0.79%)    
Infections and infestations       
Viral infection  1  0/376 (0.00%)  0 1/375 (0.27%)  1 0/379 (0.00%)  0
Injury, poisoning and procedural complications       
Cartilage injury  1  1/376 (0.27%)  1 0/375 (0.00%)  0 0/379 (0.00%)  0
Investigations       
LFT abnormal  1  0/376 (0.00%)  0 0/375 (0.00%)  0 1/379 (0.26%)  1
Musculoskeletal and connective tissue disorders       
Costochondritis  1  0/376 (0.00%)  0 0/375 (0.00%)  0 1/379 (0.26%)  1
Psychiatric disorders       
Suicidal ideation  1  0/376 (0.00%)  0 0/375 (0.00%)  0 1/379 (0.26%)  1
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/376 (0.00%)  0 1/375 (0.27%)  1 0/379 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Matching Placebo 3.0 mg Plecanatide 6.0 mg Plecanatide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/376 (3.46%)      21/375 (5.60%)      22/379 (5.80%)    
Gastrointestinal disorders       
Diarrhea  1  5/376 (1.33%)  5 12/375 (3.20%)  17 14/379 (3.69%)  16
Nervous system disorders       
Headache  1  8/376 (2.13%)  8 9/375 (2.40%)  10 8/379 (2.11%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP Regulatory Affairs & Clinical QA
Organization: Synergy Pharmaceuticals Inc.
Phone: 646-675-7283
EMail: ejaeger@synergypharma.com
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02493452    
Other Study ID Numbers: SP304203-05
First Submitted: June 23, 2015
First Posted: July 9, 2015
Results First Submitted: May 23, 2019
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019