Otilonium bromide in irritable bowel syndrome: a dose-ranging randomized double-blind placebo-controlled trial.

ABSTRACT:

Aim

To examine the efficacy and safety of otilonium bromide (OB) in treatment-sensitive functional irritable bowel syndrome (IBS) clinical parameters.

Methods

Ninety-three patients (44.8 ± 12.6 years, 69% female) with IBS symptoms complying with Rome II criteria participated in this double-blind, placebo-controlled, randomised, dose-ranging phase I/II study. Patients were administered OB 20 mg (n = 24), 40 mg (n = 23) and 80 mg (n = 23) tid or placebo (n = 23) in 4 parallel groups for 4 wk. Primary efficacy variables included abdominal discomfort, intestinal habits, number of daily evacuations and stool consistency. Secondary efficacy measures included return to regular intestinal habits and global discomfort. Safety was also assessed.

Results

Baseline clinical charac

SUBMITTER: Chmielewska-Wilkon D 

PROVIDER: S-EPMC4161814 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature