Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00765882
The ClinicalTrials.gov registry entry for NCT00765882 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 633 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 635-participant average among 4 other Chronic Constipation trials with a reported enrollment target. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Chronic Constipation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Trial of Linaclotide in Patients With Chronic Constipation
COMPLETED · Phase 3
-
Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation
COMPLETED · Phase 3
-
Perineal Self-Acupressure
COMPLETED · NA
-
Effect of Propofol on Internal Anal Sphincter Pressure During ARM
COMPLETED
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.