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NCT01429987 · ClinicalTrials.gov registry record · Phase 2
The Plecanatide Chronic Idiopathic Constipation (CIC) Study
A Phase 2 study of Chronic Idiopathic Constipation, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 951
- Enrollment target
- 20
- Study locations
NCT01429987: Completed Phase 2 study of Chronic Idiopathic Constipation, sponsored by Bausch Health Americas.
NCT01429987 is a Phase 2 study of Chronic Idiopathic Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 951 participants, above the 615-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01429987, a Phase 2 study of Chronic Idiopathic Constipation, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 951 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).
Primary Outcome
A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG plecanatide
Study Locations (20)
California
- ACRI-Phase 1,LLC - Anaheim
- Translational Research Group, INC., d/b/a Providence Clinical Research - Burbank
- GW Research, Inc - Chula Vista
- Community Clinical Trials - Orange
- Dormir Clinical Trials, Inc - Redlands
- Inland Gastroenterology Medical Associates, Inc. - Redlands
- Superior Research LLC - Sacramento
- Medical Center for Clinical Research - San Diego
- Medical Associates Research Group, Inc. - San Diego
- Progressive Clinical Research - Vista
Arizona
- East Valley Gastroenterology and Hepatology Associates, PC - Chandler
- Genova Clinical Research - Tucson
- Desert Sun Clinical Research, LLC - Tucson
- Adobe Clinical Research, LLC - Tucson
Florida
- Consultants for Clinical Research of S. Florida - Boynton Beach
- Medical Research Unlimited, LLC - Hialeah
- Nature Coast Clinical Research - Inverness
Alabama
- Coastal Clinical Research, Inc. - Mobile
Arkansas
- Preferred Research Partners, Inc - Little Rock
Colorado
- Horizons Clinical Research Center, LLC - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 951 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT01429987 record still lists
NCT01429987 is an interventional study that assigns participants to a tested intervention. The registered 951 participants enrollment target is mid-sized for trials with a published cap, above the 615-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (55% higher).
The record links to 1 condition, with Chronic Idiopathic Constipation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01429987 names 20 study sites across 6 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT01429987 about?
NCT01429987 is a clinical study titled "The Plecanatide Chronic Idiopathic Constipation (CIC) Study". This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).
What is the current status of trial NCT01429987?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 951 participants. The study started on 2011-10. Estimated completion is 2012-12.
What conditions does trial NCT01429987 study?
This clinical trial studies the following conditions: Chronic Idiopathic Constipation.
What interventions are being tested in trial NCT01429987?
The interventions under investigation include: Placebo (OTHER), plecanatide (DRUG).
Who is sponsoring clinical trial NCT01429987?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01429987 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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