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NCT00765999 · 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 Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,559
- Enrollment target
NCT00765999: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT00765999 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 1,559 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00765999, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,559 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
An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medicati
Interventions
- DRUG Linaclotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,559 participants |
| Start Date | 2008-10-31 |
| Est. Completion | 2012-01-31 |
| Phase | Phase 3 |
What the finished NCT00765999 record still lists
NCT00765999 is an interventional study that assigns participants to a tested intervention. Its 1,559 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 (102% higher).
The record links to 0 conditions, and to 1 intervention - of which Linaclotide is the first listed.
NCT00765999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00765999 about?
NCT00765999 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 NCT00765999?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,559 participants. The study started on 2008-10-31. Estimated completion is 2012-01-31.
What interventions are being tested in trial NCT00765999?
The interventions under investigation include: Linaclotide (DRUG).
Who is sponsoring clinical trial NCT00765999?
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 NCT00765999's enrollment target sits among peer trials
1,559 150th of 2000 higher than 1,851 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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