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NCT00765882 · ClinicalTrials.gov registry record · Phase 3
Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation
A Phase 3 study of Chronic Constipation, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 633
- Enrollment target
- 20
- Study locations
NCT00765882: Completed Phase 3 study of Chronic Constipation, sponsored by Forest Laboratories.
NCT00765882 is a Phase 3 study of Chronic Constipation that has completed, run by Forest Laboratories. The registered enrollment target is 633 participants, roughly in line with the 635-participant average among 4 other Chronic Constipation trials with a reported enrollment target. The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00765882, a Phase 3 study of Chronic Constipation, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 633 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder
Primary Outcome
A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation. An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Linaclotide 290 micrograms
- DRUG Linaclotide 145 micrograms
Study Locations (20)
Arizona
- Forest Investigative Site - Chandler
- Forest Investigative Site - Mesa
- Forest Investigative Site - Peoria
- Forest Investigative Site - Phoenix
- Forest Investigative Site - Scottsdale
- Forest Investigative Site - Tucson
California
- Forest Investigative Site - Burbank
- Forest Investigative Site - Encinitas
- Forest Investigative Site - Foothill Ranch
- Forest Investigative Site - Los Angeles
- Forest Investigative Site - Orange
- Forest Investigative Site - Westlake Village
Colorado
- Forest Investigative Site - Boulder
- Forest Investigative Site - Colorado Springs
- Forest Investigative Sites - Denver
- Forest Investigative Site - Longmont
- Forest Investigative Site - Wheat Ridge
Alabama
- Forest Investigative Site - Birmingham
- Forest Investigative Site - Birmingham
- Forest Investigative Site - Huntsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 633 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
What the finished NCT00765882 record still lists
NCT00765882 is an interventional study that assigns participants to a tested intervention. The registered 633 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 635-participant average among 4 other Chronic Constipation trials with a reported enrollment target.
The record links to 1 condition, with Chronic Constipation appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00765882 names 20 study sites across 4 states, led by Arizona, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT00765882 about?
NCT00765882 is a clinical study titled "Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation". The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (...
What is the current status of trial NCT00765882?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 633 participants. The study started on 2008-09. Estimated completion is 2009-08.
What conditions does trial NCT00765882 study?
This clinical trial studies the following conditions: Chronic Constipation.
What interventions are being tested in trial NCT00765882?
The interventions under investigation include: Placebo (DRUG), Linaclotide 290 micrograms (DRUG), Linaclotide 145 micrograms (DRUG).
Who is sponsoring clinical trial NCT00765882?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00765882 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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