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NCT00938717 · ClinicalTrials.gov registry record · Phase 3
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
A Phase 3 study, sponsored by Ironwood Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 805
- Enrollment target
NCT00938717: Completed Phase 3 study, sponsored by Ironwood Pharmaceuticals.
NCT00938717 is a Phase 3 study that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 805 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00938717, a Phase 3 study, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 805 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).
Primary Outcome
A patient is considered to be a 9 out of 12 week APC responder if, for at least 9 out of the first 12 weeks of the treatment period, the patient had at least 3 CSBMs, had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. SBM is
Interventions
- DRUG Linaclotide or Matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 805 participants |
| Start Date | 2009-07 |
| Est. Completion | 2010-09 |
| Phase | Phase 3 |
What the finished NCT00938717 record still lists
NCT00938717 is an interventional study that assigns participants to a tested intervention. The registered 805 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Linaclotide or Matching Placebo is the first listed.
NCT00938717 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00938717 about?
NCT00938717 is a clinical study titled "Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)". The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).
What is the current status of trial NCT00938717?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 805 participants. The study started on 2009-07. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00938717?
The interventions under investigation include: Linaclotide or Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT00938717?
This trial is sponsored by Ironwood Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00938717's enrollment target sits among peer trials
805 411th of 2000 higher than 1,589 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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