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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 is a Phase 2 study that has completed, run by Forest Laboratories. The registered enrollment target is 254 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02270983
The ClinicalTrials.gov registry entry for NCT02270983 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02270983 reports 0 study locations.
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.
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