Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone

Phase 3 Completed 439 enrolled Sucampo Pharma Americas, LLC Sucampo Pharmaceuticals, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2007-08
Primary completion: 2009-03
Completion: 2009-03

Outcome

Met primary endpoint

paper Changes from baseline in SBM frequency rates were significantly higher at week 8 (P=0.005) PMID 24716835 ↗

Publications

Cryer B, Katz S, Vallejo R, Popescu A, Ueno R. A randomized study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain. Pain Med. 2014 Nov;15(11):1825-34. doi: 10.1111/pme.12437. Epub 2014 Apr 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lubiprostone	Small molecule	24 ug	Oral