Conditions: Opioid-induced Bowel Dysfunction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 439
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: 24 mcg capsules twice daily (BID) arm 2: 0 mcg capsules twice daily (BID)

Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: 24 mcg administered orally twice daily (BID) intervention 2: Matching placebo, 0 mcg administered orally twice daily (BID)

Protocol document: