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NCT02122471 · ClinicalTrials.gov registry record · Phase 3
12-Week Study of Plecanatide for CIC (The National CIC3 Study)
A Phase 3 study of Chronic Idiopathic Constipation, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,410
- Enrollment target
- 20
- Study locations
NCT02122471: Completed Phase 3 study of Chronic Idiopathic Constipation, sponsored by Bausch Health Americas.
NCT02122471 is a Phase 3 study of Chronic Idiopathic Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 1,410 participants, above the 539-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (162% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02122471, a Phase 3 study of Chronic Idiopathic Constipation, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,410 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
The primary efficacy endpoint was measured by the number of durable overall CSBM responders over the 12-week Treatment Period. A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, including 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 t
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Plecanatide
Study Locations (20)
California
- Synergy Research Site - Anaheim
- Synergy Research Site - Artesia
- Synergy Research Site - Carmichael
- Synergy Research Site - Corona
- Synergy Research Site - Encino
- Synergy Research Site - Garden Grove
- Synergy Research Site - Garden Grove
- Synergy Research Site - Glendale
- Synergy Research Site - La Mirada
- Synergy Research Site - Laguna Hills
- Synergy Research Site - Los Angeles
Arizona
- Synergy Research Site - Chandler
- Synergy Research Site - Goodyear
- Synergy Research Site - Tucson
- Synergy Research Site - Tucson
- Synergy Research Site - Tucson
- Synergy Research Site - Tucson
- Synergy Research Site - Tucson
Alabama
- Synergy Research Site - Anniston
- Synergy Research Site - Huntsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,410 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
What the finished NCT02122471 record still lists
NCT02122471 is an interventional study that assigns participants to a tested intervention. Its 1,410 participants enrollment target places it among the larger protocols in the corpus, above the 539-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (162% 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.
NCT02122471 names 20 study sites across 3 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT02122471 about?
NCT02122471 is a clinical study titled "12-Week Study of Plecanatide for CIC (The National 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 NCT02122471?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,410 participants. The study started on 2014-04. Estimated completion is 2015-07.
What conditions does trial NCT02122471 study?
This clinical trial studies the following conditions: Chronic Idiopathic Constipation.
What interventions are being tested in trial NCT02122471?
The interventions under investigation include: Placebo (DRUG), Plecanatide (DRUG).
Who is sponsoring clinical trial NCT02122471?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02122471 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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