Phase 3
N=1,054
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Irritable Bowel Syndrome Characterized by Constipation
Bottom Line
View on ClinicalTrials.gov: NCT02387359 ↗Enrolled (actual)
1,054
Serious AEs
1.1%
Results posted
Jun 2019
Primary outcome: Primary: Number of Overall Responders - ITT Population — 63; 106; 103 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
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Overall Responders - ITT Population |
63; 106; 103 | — |
| PRIMARY Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks |
112; 145; 156 | — |
| PRIMARY Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks |
124; 169; 157 | — |
| SECONDARY Number of Sustained Efficacy Responders |
61; 99; 96 | — |
| SECONDARY Change From Baseline in Stool Consistency |
2.06; 2.02; 1.98; 1.06; 1.59; 1.86 | — |
| SECONDARY Change From Baseline in Straining |
6.39; 6.47; 6.50; -1.87; -2.69; -2.88 | — |
| SECONDARY Change From Baseline in CSBM Frequency Rate |
0.23; 0.22; 0.28; 0.86; 1.46; 1.41 | — |
| SECONDARY Number of Patients With a SBM Within 24 Hours After the First Dose |
118; 168; 175 | — |
| SECONDARY Change From Baseline in Abdominal Pain |
6.10; 5.94; 5.95; -1.79; -2.11; -2.46 | — |
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 > 35 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 (NCT02387359). 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.