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NCT01443403 · ClinicalTrials.gov registry record · Phase 2
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
A Phase 2 study, sponsored by Shionogi.
- Completed
- Registry status
- Phase 2
- Development phase
- 244
- Enrollment target
NCT01443403: Completed Phase 2 study, sponsored by Shionogi.
NCT01443403 is a Phase 2 study that has completed, run by Shionogi. The registered enrollment target is 244 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01443403, a Phase 2 study, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 244 participants
- Enrollment target
Study Summary
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
Primary Outcome
Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation. A spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per week during the 2 weeks prior to randomization. The number of SBMs per week in the last 2 weeks of treatment is defined as the averag
Interventions
- DRUG Placebo
- DRUG Naldemedine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2011-08-17 |
| Est. Completion | 2012-08-22 |
| Phase | Phase 2 |
What the finished NCT01443403 record still lists
NCT01443403 is an interventional study that assigns participants to a tested intervention. The registered 244 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 (83% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01443403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01443403 about?
NCT01443403 is a clinical study titled "A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy". The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
What is the current status of trial NCT01443403?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 244 participants. The study started on 2011-08-17. Estimated completion is 2012-08-22.
What interventions are being tested in trial NCT01443403?
The interventions under investigation include: Placebo (DRUG), Naldemedine (DRUG).
Who is sponsoring clinical trial NCT01443403?
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 NCT01443403's enrollment target sits among peer trials
244 235th of 2000 higher than 1,765 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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