NCT01298219

Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)

A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 439 (actual)
• Sponsor: Sucampo Pharma Americas, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.

Conditions

• Opioid-induced Bowel Dysfunction

Interventions

Type	Name	Description
DRUG	Lubiprostone	24 mcg administered orally twice daily (BID)
DRUG	Placebo	Matching placebo, 0 mcg administered orally twice daily (BID)

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-02-17
• Last updated: 2020-02-11
• Results posted: 2019-12-24

Locations

142 sites across 7 countries: United States, Belgium, Czechia, Germany, Poland, Sweden, United Kingdom