Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation

Summary

The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.

Timeline

Start

2009-11

Primary completion

2010-10

Completion

2010-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Elobixibat (A3309) 10 mg vs Placebo; p = 0.002; ANCOVA NCT01007123 ↗

registry analysis (superiority or other test); Elobixibat (A3309) 15 mg vs Placebo; p <0.001; ANCOVA NCT01007123 ↗

Publications

• Results Chey WD, Camilleri M, Chang L, Rikner L, Graffner H. A randomized placebo-controlled phase IIb trial of a3309, a bile acid transporter inhibitor, for chronic idiopathic constipation. Am J Gastroenterol. 2011 Oct;106(10):1803-12. doi: 10.1038/ajg.2011.162. Epub 2011 May 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Elobixibat	Small molecule	5 mg	—
Subject	Elobixibat	Small molecule	10 mg	—
Subject	Elobixibat	Small molecule	15 mg	—

Indications