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NCT01122030 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain
A Phase 2 study, sponsored by Shionogi.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT01122030: Completed Phase 2 study, sponsored by Shionogi.
NCT01122030 is a Phase 2 study that has completed, run by Shionogi. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01122030, a Phase 2 study, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.
Primary Outcome
Severity of adverse events (AEs) was graded according to the following definitions: * Mild: The subject experiences awareness of symptoms but these are easily tolerated or managed without specific treatment * Moderate: The subject experiences discomfort enough to cause interference with usual activity, and/or the condition requires specific treatment * Severe: The subject is incapacitated with inability to work or do usual activity, and/or the event requires significant treatment measures. The
Interventions
- DRUG Placebo
- DRUG Naldemedine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2010-05-19 |
| Est. Completion | 2011-03-22 |
| Phase | Phase 2 |
What the finished NCT01122030 record still lists
NCT01122030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01122030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01122030 about?
NCT01122030 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain". The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.
What is the current status of trial NCT01122030?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2010-05-19. Estimated completion is 2011-03-22.
What interventions are being tested in trial NCT01122030?
The interventions under investigation include: Placebo (DRUG), Naldemedine (DRUG).
Who is sponsoring clinical trial NCT01122030?
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 NCT01122030's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 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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