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NCT00730171 · ClinicalTrials.gov registry record · Phase 3
An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
A Phase 3 study, sponsored by Ironwood Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,743
- Enrollment target
NCT00730171: Completed Phase 3 study, sponsored by Ironwood Pharmaceuticals.
NCT00730171 is a Phase 3 study that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 1,743 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00730171, a Phase 3 study, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,743 participants
- Enrollment target
Study Summary
The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).
Primary Outcome
For RI and Phase 2 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of open-label study drug, or was present before the day of the first dose of open-label study drug but increased in severity on or after that day. For Phase 3 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of double-blind study drug in trial MCP-103-302 or MCP-103-3
Interventions
- DRUG Linaclotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,743 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT00730171 record still lists
NCT00730171 is an interventional study that assigns participants to a tested intervention. Its 1,743 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 1 intervention - of which Linaclotide is the first listed.
NCT00730171 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00730171 about?
NCT00730171 is a clinical study titled "An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation". The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).
What is the current status of trial NCT00730171?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,743 participants. The study started on 2008-09. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00730171?
The interventions under investigation include: Linaclotide (DRUG).
Who is sponsoring clinical trial NCT00730171?
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 NCT00730171's enrollment target sits among peer trials
1,743 129th of 2000 higher than 1,872 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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