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NCT01298219 · ClinicalTrials.gov registry record · Phase 3
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
A Phase 3 study, sponsored by Sucampo Pharma Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 439
- Enrollment target
NCT01298219: Completed Phase 3 study, sponsored by Sucampo Pharma Americas.
NCT01298219 is a Phase 3 study that has completed, run by Sucampo Pharma Americas. The registered enrollment target is 439 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01298219, a Phase 3 study, has completed, sponsored by Sucampo Pharma Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 439 participants
- Enrollment target
Study Summary
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
Primary Outcome
Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (≥ 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (≥ 3 SBMs per week) for at least 9 of the 12 treatment weeks.
Interventions
- DRUG Placebo
- DRUG Lubiprostone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 439 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT01298219 record still lists
NCT01298219 is an interventional study that assigns participants to a tested intervention. The registered 439 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 (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01298219 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01298219 about?
NCT01298219 is a clinical study titled "Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)". The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
What is the current status of trial NCT01298219?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 439 participants. The study started on 2010-12. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01298219?
The interventions under investigation include: Placebo (DRUG), Lubiprostone (DRUG).
Who is sponsoring clinical trial NCT01298219?
This trial is sponsored by Sucampo Pharma Americas, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01298219's enrollment target sits among peer trials
439 872nd of 2000 higher than 1,127 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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