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NCT00460811 · ClinicalTrials.gov registry record · Phase 2
Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
A Phase 2 study, sponsored by Ironwood Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 420
- Enrollment target
NCT00460811: Completed Phase 2 study, sponsored by Ironwood Pharmaceuticals.
NCT00460811 is a Phase 2 study that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 420 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (216% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00460811, a Phase 2 study, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 420 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.
Primary Outcome
The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period. The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours.
Interventions
- DRUG Matching placebo
- DRUG Linaclotide Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-04 |
| Phase | Phase 2 |
What the finished NCT00460811 record still lists
NCT00460811 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (216% higher).
The record links to 0 conditions, and to 2 interventions - of which Matching placebo is the first listed.
NCT00460811 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00460811 about?
NCT00460811 is a clinical study titled "Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)". The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.
What is the current status of trial NCT00460811?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 420 participants. The study started on 2007-04. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00460811?
The interventions under investigation include: Matching placebo (DRUG), Linaclotide Acetate (DRUG).
Who is sponsoring clinical trial NCT00460811?
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 NCT00460811's enrollment target sits among peer trials
420 91st of 2000 higher than 1,910 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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