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NCT01642914 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 487
- Enrollment target
NCT01642914: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT01642914 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 487 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01642914, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 487 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.
Primary Outcome
A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.
Interventions
- DRUG Matching placebo
- DRUG Linaclotide 290 micrograms
- DRUG Linaclotide 145 micrograms
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 487 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
What the finished NCT01642914 record still lists
NCT01642914 is an interventional study that assigns participants to a tested intervention. The registered 487 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 3 interventions - of which Matching placebo is the first listed.
NCT01642914 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01642914 about?
NCT01642914 is a clinical study titled "Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating". The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will b...
What is the current status of trial NCT01642914?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 487 participants. The study started on 2012-08. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01642914?
The interventions under investigation include: Matching placebo (DRUG), Linaclotide 290 micrograms (DRUG), Linaclotide 145 micrograms (DRUG).
Who is sponsoring clinical trial NCT01642914?
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 NCT01642914's enrollment target sits among peer trials
487 786th of 2000 higher than 1,212 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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