NCT02809105

A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation

Phase 3 Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study and an Open-label, Uncontrolled, Long-term Dosing Study in Patients With Chronic Constipation (Not Including Constipation Due to Organic Diseases) -

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to verify the efficacy and investigate the safety of the study drug when ASP0456 is administered orally for 4 weeks and 52 weeks.

Detailed description

This study consists of two parts. In Part I, ASP0456 or placebo will be administered orally in a blind manner. In Part II, the long-term safety and efficacy of ASP0456 will be evaluated in patients who have participated in the study and completed the Part I.

Conditions

• Chronic Constipation

Interventions

Type	Name	Description
DRUG	linaclotide	Oral administration once daily
DRUG	Placebo	Oral administration once daily

Timeline

• Start date: 2016-06-24
• Primary completion: 2016-11-14
• Completion: 2017-11-10
• First posted: 2016-06-22
• Last updated: 2024-10-18

Locations

39 sites across 1 country: Japan