Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial

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From: PLoS ONE(Vol. 10, Issue 7)
Publisher: Public Library of Science
Document Type: Report
Length: 7,337 words
Lexile Measure: 1720L

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Abstract :

Background Abdominal bloating is a common and bothersome symptom of chronic idiopathic constipation. The objective of this trial was to evaluate the efficacy and safety of linaclotide in patients with chronic idiopathic constipation and concomitant moderate-to-severe abdominal bloating. Methods This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 [mu]g) or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score [greater than or equal to]5 (self-assessment: 0 10-point numerical rating scale) during the 14-day baseline period. Patients reported abdominal symptoms (including bloating) and bowel symptoms daily; adverse events were monitored. The primary responder endpoint required patients to have [greater than or equal to]3 complete spontaneous bowel movements/week with an increase of [greater than or equal to]1 from baseline, for [greater than or equal to]9 of 12 weeks. The primary endpoint compared linaclotide 145 [mu]g vs. placebo. Results The intent-to-treat population included 483 patients (mean age=47.3 years, female=91.5%, white=67.7%). The primary endpoint was met by 15.7% of linaclotide 145 [mu]g patients vs. 7.6% of placebo patients (P Conclusions Once-daily linaclotide (145 and 290 [mu]g) significantly improved bowel and abdominal symptoms in chronic idiopathic constipation patients with moderate-to-severe baseline abdominal bloating; in particular, linaclotide significantly improved abdominal bloating compared to placebo, an important finding given the lack of agents available to treat abdominal bloating in chronic idiopathic constipation patients. Trial Registration ClinicalTrials.gov NCT01642914

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Gale Document Number: GALE|A455367847