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NCT02270983 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain
A Phase 2 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 254
- Enrollment target
NCT02270983: Completed Phase 2 study, sponsored by Forest Laboratories.
NCT02270983 is a Phase 2 study that has completed, run by Forest Laboratories. The registered enrollment target is 254 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02270983, a Phase 2 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 254 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been present for a minimum of 3 months. This study included up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients meeting the entry criteria were randomized to 1 of 2 doses of linaclotide or placebo once per day for 8 weeks. This 8-week study assessed the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of OIC.
Primary Outcome
Change from baseline in 8-Week SBM frequency rate (SBMs/week) during the Treatment Period.
Interventions
- DRUG Placebo
- DRUG Linaclotide 290 micrograms
- DRUG Linaclotide 145 micrograms
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2014-10-31 |
| Est. Completion | 2015-10-31 |
| Phase | Phase 2 |
What the finished NCT02270983 record still lists
NCT02270983 is an interventional study that assigns participants to a tested intervention. The registered 254 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 (91% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02270983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02270983 about?
NCT02270983 is a clinical study titled "Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain". The purpose of this study was to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been present for a minimum of 3 months. This study included up to a 4-week Screen...
What is the current status of trial NCT02270983?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 254 participants. The study started on 2014-10-31. Estimated completion is 2015-10-31.
What interventions are being tested in trial NCT02270983?
The interventions under investigation include: Placebo (DRUG), Linaclotide 290 micrograms (DRUG), Linaclotide 145 micrograms (DRUG).
Who is sponsoring clinical trial NCT02270983?
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 NCT02270983's enrollment target sits among peer trials
254 219th of 2000 higher than 1,781 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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