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NCT01982240 · ClinicalTrials.gov registry record · Phase 3
12-Week Study of Plecanatide for CIC (The CIC3 Study)
A Phase 3 study of Chronic Idiopathic Constipation, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,394
- Enrollment target
- 20
- Study locations
NCT01982240: Completed Phase 3 study of Chronic Idiopathic Constipation, sponsored by Bausch Health Americas.
NCT01982240 is a Phase 3 study of Chronic Idiopathic Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 1,394 participants, above the 541-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (158% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01982240, a Phase 3 study of Chronic Idiopathic Constipation, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,394 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
Primary Outcome
A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, included at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bisacodyl
- DRUG Plecanatide
Study Locations (20)
California
- Synergy Research Site - Anaheim
- Synergy Research Site - Anaheim
- Synergy Research Site - Carlsbad
- Synergy Research Site - Cerritos
- Synergy Research Site - Chula Vista
- Synergy Research Site - El Cajon
- Synergy Research Site - Encinitas
Alabama
- Synergy Research Site - Birmingham
- Synergy Research Site - Dothan
- Synergy Research Site - Gulf Shores
- Synergy Research Site - Huntsville
- Synergy Research Site - Mobile
Arizona
- Synergy Research Site - Mesa
- Synergy Research Site - Phoenix
- Synergy Research Site - Phoenix
- Synergy Research Site - Tempe
- Synergy Research Site - Tucson
Arkansas
- Synergy Research Site - Hot Springs
- Synergy Research Site - Little Rock
- Synergy Research Site - North Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,394 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
What the finished NCT01982240 record still lists
NCT01982240 is an interventional study that assigns participants to a tested intervention. Its 1,394 participants enrollment target places it among the larger protocols in the corpus, above the 541-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (158% higher).
The record links to 1 condition, with Chronic Idiopathic Constipation appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01982240 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01982240 about?
NCT01982240 is a clinical study titled "12-Week Study of Plecanatide for CIC (The CIC3 Study)". The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
What is the current status of trial NCT01982240?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,394 participants. The study started on 2013-11. Estimated completion is 2015-06.
What conditions does trial NCT01982240 study?
This clinical trial studies the following conditions: Chronic Idiopathic Constipation.
What interventions are being tested in trial NCT01982240?
The interventions under investigation include: Placebo (DRUG), Bisacodyl (DRUG), Plecanatide (DRUG).
Who is sponsoring clinical trial NCT01982240?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01982240 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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