A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Overview
- Phase
- Phase 3
- Intervention
- Plecanatide
- Conditions
- Irritable Bowel Syndrome Characterized by Constipation
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 1054
- Locations
- 2
- Primary Endpoint
- Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed Description
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. Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow for any necessary diagnostic procedures, allow for required washout of medications and to determine study eligibility. If otherwise eligible based on screening criteria, patients will undergo a 2-week baseline assessment using an electronic diary where they will record daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS), abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary assessment just prior to the randomization visit will be used to confirm IBS-C and study eligibility as well as define the patient's baseline from which change will be determined. Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments. Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily electronic diaries. Patients will then return to the clinical site for a final follow-up visit during Week 14 following randomization. The planned duration of participation in this study will be at least 116 days from signing of informed consent through post-treatment or up to approximately 135 days with visit windows considered.
Investigators
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 \< 18
- •Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
- •Women who are pregnant or lactating
- •Diagnosis of IBS-D or IBS-M
- •Organic or obstructive disease of the small or large intestine
- •Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
- •Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
- •Unstable medical illness
Arms & Interventions
3.0 mg plecanatide
Plecanatide 3.0 mg dosed daily for 12 weeks
Intervention: Plecanatide
6.0 mg plecanatide
Plecanatide 6.0 mg dosed daily for 12 weeks
Intervention: Plecanatide
Matching placebo
Placebo dosed daily for 12 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks
Time Frame: 12 Weeks
An Abdominal Pain Intensity Responder was a patient who had a decrease of 30% from baseline for abdominal pain intensity. Baseline was 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.
Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks
Time Frame: 12 weeks
A Stool Frequency Responder is defined as 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.
Number of Overall Responders - ITT Population
Time Frame: 12 Weeks
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 one complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.
Secondary Outcomes
- Change From Baseline in Abdominal Pain(Baseline and 12-Week)
- Change From Baseline in Stool Consistency(Baseline and 12-Week)
- Number of Patients With a SBM Within 24 Hours After the First Dose(Up to 24 hours after first dose of study drug)
- Number of Sustained Efficacy Responders(12 weeks)
- Change From Baseline in Straining(Baseline and 12-week)
- Change From Baseline in CSBM Frequency Rate(Baseline and 12-Week)