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NCT01965158 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
A Phase 3 study of Opioid-induced Constipation, sponsored by Shionogi.
- Completed
- Registry status
- Phase 3
- Development phase
- 547
- Enrollment target
- 20
- Study locations
NCT01965158: Completed Phase 3 study of Opioid-induced Constipation, sponsored by Shionogi.
NCT01965158 is a Phase 3 study of Opioid-induced Constipation that has completed, run by Shionogi. The registered enrollment target is 547 participants, below the 7,123-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01965158, a Phase 3 study of Opioid-induced Constipation, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 547 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.
Primary Outcome
A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of rescue laxative therapy during the 24 hours prior to the BM. A responder was defined as a participant having 9 or more positive response weeks out of the 12-week Treatment Period and 3 positive response weeks out of last 4 w
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Naldemedine
Study Locations (20)
Florida
- Shionogi Research Site - Miami
- Shionogi Research Site - Miami Springs
- Shionogi Research Site - Orlando
- Shionogi Research Site - Sarasota
- Shionogi Research Site - West Palm Beach
- Shionogi Research Site - Winter Park
California
- Shionogi Research Site - Fresno
- Shionogi Research Site - Long Beach
- Shionogi Research Site - National City
- Shionogi Research Site - North Hollywood
- Shionogi Research Site - Oceanside
Michigan
- Shionogi Research Site - Caro
- Shionogi Research Site - Flint
Alabama
- Shionogi Research Site - Birmingham
Arizona
- Shionogi Research Site - Phoenix
Colorado
- Shionogi Research Site - Golden
Georgia
- Shionogi Research Site - Marietta
Louisiana
- Shionogi Research Site - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 547 participants |
| Start Date | 2013-08-29 |
| Est. Completion | 2015-01-22 |
| Phase | Phase 3 |
What the finished NCT01965158 record still lists
NCT01965158 is an interventional study that assigns participants to a tested intervention. The registered 547 participants enrollment target is mid-sized for trials with a published cap, below the 7,123-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Opioid-induced Constipation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01965158 names 20 study sites across 10 states, led by Florida, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT01965158 about?
NCT01965158 is a clinical study titled "Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation". The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.
What is the current status of trial NCT01965158?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 547 participants. The study started on 2013-08-29. Estimated completion is 2015-01-22.
What conditions does trial NCT01965158 study?
This clinical trial studies the following conditions: Opioid-induced Constipation.
What interventions are being tested in trial NCT01965158?
The interventions under investigation include: Placebo (DRUG), Naldemedine (DRUG).
Who is sponsoring clinical trial NCT01965158?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01965158 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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