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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 is a Phase 3 study that has completed, run by Sucampo Pharma Americas. The registered enrollment target is 439 participants.
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.
Interventions
- DRUG Placebo
- DRUG Lubiprostone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 439 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01298219
The ClinicalTrials.gov registry entry for NCT01298219 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 439 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sucampo Pharma Americas, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01298219 reports 0 study locations.
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.
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