NCT01714843

A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

Phase II Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study in Patients With Constipation-predominant Irritable Bowel Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 559 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.

Detailed description

This study is a multicenter, double-blind, placebo-controlled, parallel-group, comparative study to investigate dose-responses of efficacy, safety, and pharmacokinetics of ASP0456 in patients with constipation-predominant irritable bowel syndrome (IBS-C) according to the Rome III Diagnostic Criteria (2006 revised edition, established by the Rome III Committee) after oral administration of ASP0456.

Conditions

• Constipation-predominant Irritable Bowel Syndrome (IBS-C)

Interventions

Type	Name	Description
DRUG	linaclotide	oral
DRUG	placebo	oral

Timeline

• Start date: 2012-08-10
• Primary completion: 2013-12-07
• Completion: 2013-12-07
• First posted: 2012-10-26
• Last updated: 2024-10-18

Locations

4 sites across 1 country: Japan