Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

Phase 3 Completed 500 enrolled Astellas Pharma Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study is to evaluate the efficacy and safety of ASP0456 in patients with constipation predominant irritable bowel syndrome (IBS-C).

Timeline

Start: 2014-10-21
Primary completion: 2015-09-19
Completion: 2016-03-29

Outcome

Met primary endpoint

paper The responder rates for global improvement and for CSBM frequency were significantly higher for linaclotide compared to placebo (P < 0.001). PMID 30136447 ↗

release “Top-line data from the Phase III trial in Japan indicate linaclotide-treated patients showed statistically significant improvement compared to placebo-treated patients” ironwoodpharma.com ↗

release “Data from the Phase III trial in Japan indicate that patients treated with 500 mcg of linaclotide showed statistically significant improvement compared to placebo-treated patients” ironwoodpharma.com ↗

release “The data indicates linaclotide-treated patients showed statistically significant improvement compared to placebo-treated patients for both of the two co-primary endpoints.” astellas.com ↗

Publications

Fukudo S, Miwa H, Nakajima A, Haruma K, Kosako M, Nakagawa A, Akiho H, Yamaguchi Y, Johnston JM, Currie M, Kinoshita Y. A randomized controlled and long-term linaclotide study of irritable bowel syndrome with constipation patients in Japan. Neurogastroenterol Motil. 2018 Dec;30(12):e13444. doi: 10.1111/nmo.13444. Epub 2018 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Linaclotide	Peptide	0.5 mg	Oral