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NCT00730015 · ClinicalTrials.gov registry record · Phase 3
Trial of Linaclotide in Patients With Chronic Constipation
A Phase 3 study of Chronic Constipation, sponsored by Ironwood Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 643
- Enrollment target
- 20
- Study locations
NCT00730015: Completed Phase 3 study of Chronic Constipation, sponsored by Ironwood Pharmaceuticals.
NCT00730015 is a Phase 3 study of Chronic Constipation that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 643 participants, roughly in line with the 632-participant average among 4 other Chronic Constipation trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00730015, a Phase 3 study of Chronic Constipation, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 643 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 dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.
Primary Outcome
A 12-week CSBM Overall Responder 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 be
Conditions Studied
Interventions
- DRUG Matching Placebo
- DRUG Linaclotide
Study Locations (20)
California
- Ironwood Investigational Site - Anaheim
- Ironwood Investigational Site - Chula Vista
- Ironwood Investigational Site - Encinitas
- Ironwood Investigational Site - Garden Grove
- Ironwood Investigational Site - Laguna Hills
- Ironwood Investigational Site - Los Angeles
- Ironwood Investigational Site - Orange
- Ironwood Investigational Site - Sacramento
- Ironwood Investigational Site - San Carlos
- Ironwood Investigational Site - San Diego
- Ironwood Investigational Site - San Diego
- Ironwood Investigational Site - San Diego
Arizona
- Ironwood Investigational Site - Chandler
- Ironwood Investigational Site - Phoenix
- Ironwood Investigational Site - Tucson
- Ironwood Investigational Site - Tuscon
Alabama
- Ironwood Investigational Site - Birmingham
- Ironwood Investigational Site - Huntsville
Arkansas
- Ironwood Investigational Site - Sherwood
Colorado
- Ironwood Investigational Site - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 643 participants |
| Start Date | 2008-08 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00730015 record still lists
NCT00730015 is an interventional study that assigns participants to a tested intervention. The registered 643 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 632-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 2 interventions - of which Matching Placebo is the first listed.
NCT00730015 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT00730015 about?
NCT00730015 is a clinical study titled "Trial of Linaclotide in 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 dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSB...
What is the current status of trial NCT00730015?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 643 participants. The study started on 2008-08. Estimated completion is 2009-10.
What conditions does trial NCT00730015 study?
This clinical trial studies the following conditions: Chronic Constipation.
What interventions are being tested in trial NCT00730015?
The interventions under investigation include: Matching Placebo (DRUG), Linaclotide (DRUG).
Who is sponsoring clinical trial NCT00730015?
This trial is sponsored by Ironwood Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00730015 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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