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NCT03120520 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
A Phase 2 study of Chronic Idiopathic Constipation, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
- 20
- Study locations
NCT03120520: Completed Phase 2 study of Chronic Idiopathic Constipation, sponsored by Bausch Health Americas.
NCT03120520 is a Phase 2 study of Chronic Idiopathic Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 124 participants, below the 753-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03120520, a Phase 2 study of Chronic Idiopathic Constipation, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to \< 18 years diagnosed with Chronic Idiopathic Constipation.
Primary Outcome
An Overall Responder is a participant who was a Spontaneous Bowel Movement (SBM) responder for the last 2 weeks of the Treatment Period. An SBM responder is defined as a participant who had \>3 SBMs per week. SBM was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. Participants missing with respect to the outcome measure were scored as non-responders.
Conditions Studied
Interventions
- DRUG Matching placebo
- DRUG Plecanatide
Study Locations (20)
California
- Synergy Research Site - Cerritos
- Synergy Research Site - Corona
- Synergy Research Site - Downey
- Synergy Research Site - Huntington Beach
- Synergy Research Site - Sacramento
- Synergy Research Site - Ventura
Florida
- Synergy Research Site - DeLand
- Synergy Research Site - Doral
- Synergy Research Site - Hialeah
- Synergy Research Site - Miami
- Synergy Research Site - Orlando
- Synergy Research Site - Tampa
Georgia
- Synergy Research Site - Snellville
- Synergy Research Site - Thomaston
Idaho
- Synergy Research Site - Idaho Falls
- Synergy Research Site - Meridian
Alabama
- Synergy Research Site - Foley
Arkansas
- Synergy Research Site - Jonesboro
Delaware
- Synergy Research Site - Wilmington
Kentucky
- Synergy Research Site - Nicholasville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2017-01 |
| Est. Completion | 2018-09-07 |
| Phase | Phase 2 |
What the finished NCT03120520 record still lists
NCT03120520 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 753-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Chronic Idiopathic Constipation appearing as the primary indexed condition, and to 2 interventions - of which Matching placebo is the first listed.
NCT03120520 names 20 study sites across 8 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT03120520 about?
NCT03120520 is a clinical study titled "An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation". This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to \< 18 years diagnosed with Chronic Idiopathic Constipation.
What is the current status of trial NCT03120520?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2017-01. Estimated completion is 2018-09-07.
What conditions does trial NCT03120520 study?
This clinical trial studies the following conditions: Chronic Idiopathic Constipation.
What interventions are being tested in trial NCT03120520?
The interventions under investigation include: Matching placebo (DRUG), Plecanatide (DRUG).
Who is sponsoring clinical trial NCT03120520?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03120520 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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