Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society
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Neurogastroenterol. Motil. · Dec 2018
Randomized Controlled Trial Multicenter StudyA randomized controlled and long-term linaclotide study of irritable bowel syndrome with constipation patients in Japan.
Clinical testing was required to verify the effect of linaclotide 0.5 mg/d in patients with irritable bowel syndrome with constipation (IBS-C) in Japan. ⋯ This study suggests that a linaclotide dose of 0.5 mg is effective and safe for IBS-C patients in Japan.
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Neurogastroenterol. Motil. · Dec 2018
Randomized Controlled Trial Multicenter StudyDose-finding study of linaclotide in Japanese patients with chronic constipation: A phase II randomized, double-blind, and placebo-controlled study.
Based on the previous phase II/III studies of irritable bowel syndrome with constipation (IBS-C) in Japan that demonstrated the efficacy and safety of linaclotide 0.5 mg/d, we evaluated linaclotide at doses of 0.5 mg/d and lower in the treatment of Japanese patients with chronic constipation (CC). ⋯ Our results suggest that 0.0625, 0.125, 0.25, and 0.5 mg/d are effective doses of linaclotide for treating CC in Japanese patients. ClinicalTrials.gov: NCT02425722, supported by Astellas Pharma, Inc.