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NCT01993940 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
A Phase 3 study, sponsored by Shionogi.
- Completed
- Registry status
- Phase 3
- Development phase
- 553
- Enrollment target
NCT01993940: Completed Phase 3 study, sponsored by Shionogi.
NCT01993940 is a Phase 3 study that has completed, run by Shionogi. The registered enrollment target is 553 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01993940, a Phase 3 study, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 553 participants
- Enrollment target
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
Interventions
- DRUG Placebo
- DRUG Naldemedine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 553 participants |
| Start Date | 2013-11-04 |
| Est. Completion | 2015-06-09 |
| Phase | Phase 3 |
What the finished NCT01993940 record still lists
NCT01993940 is an interventional study that assigns participants to a tested intervention. The registered 553 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 (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01993940 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01993940 about?
NCT01993940 is a clinical study titled "Efficacy and Safety of Naldemedine in Treating 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 NCT01993940?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 553 participants. The study started on 2013-11-04. Estimated completion is 2015-06-09.
What interventions are being tested in trial NCT01993940?
The interventions under investigation include: Placebo (DRUG), Naldemedine (DRUG).
Who is sponsoring clinical trial NCT01993940?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01993940's enrollment target sits among peer trials
553 678th of 2000 higher than 1,323 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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