Phase 3
N=1,135
Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)
Irritable Bowel Syndrome Characterized by Constipation
Bottom Line
View on ClinicalTrials.gov: NCT02493452 ↗Enrolled (actual)
1,135
Serious AEs
0.5%
Results posted
Jun 2019
Primary outcome: Primary: Number of Overall Responders - ITT Population — 54; 81; 91 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Plecanatide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Overall Responders - ITT Population |
54; 81; 91 | — |
| PRIMARY Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks |
88; 123; 129 | — |
| PRIMARY Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks |
106; 129; 148 | — |
| SECONDARY Number of Sustained Efficacy Responders |
53; 78; 90 | — |
| SECONDARY Change From Baseline in Stool Consistency |
1.99; 1.91; 1.86; 1.04; 1.55; 1.45 | — |
| SECONDARY Change From Baseline in Straining |
6.75; 6.84; 6.87; -1.66; -2.35; -2.35 | — |
| SECONDARY Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement |
0.24; 0.26; 0.27; 0.80; 1.23; 1.63 | — |
| SECONDARY Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication |
119; 157; 167 | — |
| SECONDARY Change From Baseline in Abdominal Pain |
6.40; 6.56; 6.48; -1.42; -2.00; -1.87 | — |
Summary
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.
Eligibility Criteria
Inclusion Criteria
- Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C
Exclusion Criteria
- Refusal or inability to sign informed consent for the trial
- Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
- BMI ≥ 40 or 3X ULN in the absence of a conjugation defect
- Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor
Data sourced from ClinicalTrials.gov (NCT02493452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.