NCT02425722

A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation

Phase II Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study in Patients With Chronic Constipation (Not Including Constipation Due to Organic Diseases)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 383 (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 investigate dose-responses of efficacy and safety of ASP0456 in patients with chronic constipation (diagnosed by Rome III criteria of functional constipation (FC), not including constipation due to organic diseases) compared to placebo and to find the appropriate dose for P3 study.

Detailed description

To determine optimum dose of ASP0456 for the patients with chronic constipation (not including constipation due to organic diseases) in Japan based on its efficacy and safety, multicentered, placebo-controlled, double-blind, parallel group comparative study will be conducted. After two-week observation period, the patient who meets the primary registration criteria will be randomized to the one from five groups and will start treatment period. The patients will take once daily orally before the breakfast for two weeks.

Conditions

• Chronic Constipation

Interventions

Type	Name	Description
DRUG	ASP0456	oral
DRUG	Placebo	oral

Timeline

• Start date: 2015-04-13
• Primary completion: 2015-10-31
• Completion: 2015-10-31
• First posted: 2015-04-24
• Last updated: 2024-10-18

Locations

50 sites across 1 country: Japan