Study Details

Phase III Study to evaluate the efficacy and safety of ASP0456 in patients with constipation predominant irritable bowel syndrome

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT02316899

Astellas Study ID

The unique identification code given by the study sponsor.

0456-CL-0031

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Irritable Bowel Syndrome (IBS)

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

20 years - 79 years

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Oct 2014 - Mar 2016

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

500

Phase III Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study and Long-term Study in Patients with Irritable bowel syndrome with constipation (IBS-C)

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site JP00021

Tokyo, Japan

Site JP00052

Osaka, Japan

Site JP00013

Tokyo, Japan

Site JP00017

Tokyo, Japan

Site JP00044

Saitama, Japan

Site JP00061

Fukuoka, Japan

Site JP00032

Kanagawa, Japan

Site JP00022

Tokyo, Japan

Site JP00008

Tokyo, Japan

Site JP00051

Osaka, Japan

Site JP00057

Hyogo, Japan

Site JP00039

Chiba, Japan

Site JP00001

Hokkaido, Japan

Site JP00007

Hokkaido, Japan

Site JP00038

Chiba, Japan

Site JP00016

Tokyo, Japan

Site JP00011

Tokyo, Japan

Site JP00042

Chiba, Japan

Site JP00058

Hyogo, Japan

Site JP00053

Osaka, Japan

Site JP00030

Kanagawa, Japan

Site JP00029

Tokyo, Japan

Site JP00015

Tokyo, Japan

Site JP00050

Osaka, Japan

Site JP00009

Tokyo, Japan

Site JP00035

Kanagawa, Japan

Site JP00024

Tokyo, Japan

Site JP00019

Tokyo, Japan

Site JP00004

Aichi, Japan

Site JP00014

Tokyo, Japan

Site JP00026

Tokyo, Japan

Site JP00047

Saitama, Japan

Site JP00036

Kanagawa, Japan

Site JP00006

Hokkaido, Japan

Site JP00003

Osaka, Japan

Site JP00043

Saitama, Japan

Site JP00033

Kanagawa, Japan

Site JP00045

Saitama, Japan

Site JP00023

Tokyo, Japan

Site JP00059

Hyogo, Japan

Site JP00056

Kyoto, Japan

Site JP00027

Tokyo, Japan

Site JP00005

Tokyo, Japan

Site JP00020

Tokyo, Japan

Site JP00018

Tokyo, Japan

Site JP00049

Aichi, Japan

Site JP00031

Kanagawa, Japan

Site JP00060

Fukuoka, Japan

Site JP00028

Tokyo, Japan

Site JP00041

Chiba, Japan

Site JP00054

Osaka, Japan

Site JP00010

Tokyo, Japan

Site JP00012

Tokyo, Japan

Site JP00046

Saitama, Japan

Site JP00002

Fukuoka, Japan

Site JP00034

Kanagawa, Japan

Site JP00037

Kanagawa, Japan

Site JP00048

Aichi, Japan

Site JP00025

Tokyo, Japan

Site JP00040

Chiba, Japan

Site JP00055

Osaka, Japan