drugset / Trial / NCT02425722

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

NCT02425722

Phase 2 Completed 383 enrolled Astellas Pharma Inc
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-04-13
Primary completion
2015-10-31
Completion
2015-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Linaclotide Peptide 0.0625 mg Oral
Subject Linaclotide Peptide 0.125 mg Oral
Subject Linaclotide Peptide 0.25 mg Oral
Subject Linaclotide Peptide 0.5 mg Oral

Indications