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NCT01965652 · ClinicalTrials.gov registry record · Phase 3
Long Term Safety of Naldemedine
A Phase 3 study, sponsored by Shionogi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,246
- Enrollment target
NCT01965652: Completed Phase 3 study, sponsored by Shionogi.
NCT01965652 is a Phase 3 study that has completed, run by Shionogi. The registered enrollment target is 1,246 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01965652, a Phase 3 study, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,246 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.
Primary Outcome
A serious adverse event was defined as any adverse event (AE) that resulted in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization were considered an SAE when, based upon appropriate medical judgment, they jeopardized the patient or require
Interventions
- DRUG Placebo
- DRUG Naldemedine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,246 participants |
| Start Date | 2013-09-24 |
| Est. Completion | 2016-01-12 |
| Phase | Phase 3 |
What the finished NCT01965652 record still lists
NCT01965652 is an interventional study that assigns participants to a tested intervention. Its 1,246 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01965652 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01965652 about?
NCT01965652 is a clinical study titled "Long Term Safety of Naldemedine". The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.
What is the current status of trial NCT01965652?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,246 participants. The study started on 2013-09-24. Estimated completion is 2016-01-12.
What interventions are being tested in trial NCT01965652?
The interventions under investigation include: Placebo (DRUG), Naldemedine (DRUG).
Who is sponsoring clinical trial NCT01965652?
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 NCT01965652's enrollment target sits among peer trials
1,246 210th of 2000 higher than 1,790 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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