The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials.

ABSTRACT:

Background

Few clinical trials in chronic idiopathic constipation (CIC) patients have evaluated abdominal symptom severity and whether CIC patients with abdominal symptoms respond similarly to patients with limited abdominal symptoms.

Aims

To examine abdominal symptom severity and relationships between symptoms and global measures at baseline; compare linaclotide's effect on symptoms in subpopulations with more or less abdominal pain; and assess relationships between symptom improvement and global measures in these two subpopulations.

Methods

In two phase 3 trials, patients meeting modified Rome II CIC criteria were assigned to linaclotide 145 μg, 290 μg, or placebo once daily. Patients rated abdominal and bowel symptoms daily during 2-week pre-treatment and 12-week t

SUBMITTER: Chang L 

PROVIDER: S-EPMC4278547 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature