A randomized study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain.

ABSTRACT:

Objective

To evaluate the efficacy and safety of oral lubiprostone for relieving symptoms of opioid-induced constipation (OIC) in patients with chronic noncancer pain.

Design

Prospective, randomized, double-blind, placebo-controlled trial.

Setting

Seventy-nine US and Canadian centers.

Subjects

Patients aged ≥ 18 years with OIC, defined as <3 spontaneous bowel movements (SBMs) per week.

Methods

Patients received lubiprostone 24 mcg or placebo twice daily for 12 weeks. The primary endpoint was change from baseline in SBM frequency at week 8.

Results

Among randomized patients (N=418; lubiprostone, N=210; placebo, N=208), most completed the study (lubiprostone, 67.1%; placebo, 69.7%). The safety and efficacy (intent-to-treat) populations included 414

SUBMITTER: Cryer B 

PROVIDER: S-EPMC4282321 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature