A randomized, placebo-controlled trial of lubiprostone for opioid-induced constipation in chronic noncancer pain.

ABSTRACT:

Objectives

This multicenter, phase 3 trial evaluated oral lubiprostone for constipation associated with non-methadone opioids in patients with chronic noncancer-related pain.

Methods

Adults with opioid-induced constipation (OIC; <3 spontaneous bowel movements [SBMs] per week) were randomized 1:1 to double-blind lubiprostone 24 μg or placebo twice daily for 12 weeks. The primary end point was the overall SBM response rate. Responders had at least moderate response (≥1 SBM improvement over baseline frequency) in all treatment weeks with available observed data, as well as full response (≥3 SBMs per week) for at least 9 of the 12 treatment weeks.

Results

In total, 431 patients were randomized; 212 each received lubiprostone and placebo, and 7 were not treated. Overall, t

SUBMITTER: Jamal MM 

PROVIDER: S-EPMC4424379 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature