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NCT00948818 · ClinicalTrials.gov registry record · Phase 3
Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 803
- Enrollment target
NCT00948818: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT00948818 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 803 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
NCT00948818, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 803 participants
- Enrollment target
Study Summary
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.
Primary Outcome
A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses the worst of a patient's 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. A C
Interventions
- DRUG Matching placebo
- DRUG Linaclotide 290 micrograms
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 803 participants |
| Start Date | 2009-07 |
| Est. Completion | 2010-08 |
| Phase | Phase 3 |
What the finished NCT00948818 record still lists
NCT00948818 is an interventional study that assigns participants to a tested intervention. The registered 803 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 2 interventions - of which Matching placebo is the first listed.
NCT00948818 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00948818 about?
NCT00948818 is a clinical study titled "Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation". The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal P...
What is the current status of trial NCT00948818?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 803 participants. The study started on 2009-07. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00948818?
The interventions under investigation include: Matching placebo (DRUG), Linaclotide 290 micrograms (DRUG).
Who is sponsoring clinical trial NCT00948818?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00948818's enrollment target sits among peer trials
803 413th of 2000 higher than 1,588 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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