Completed

A Randomized, Double-blind, Placebo-controlled, Phase II Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

KWA-0711

+ Placebo

Drug
Who is being recruted

Constipation+3

+ Digestive System Diseases

+ Gastrointestinal Diseases

Over 20 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
See protocol details

Summary

Principal SponsorKissei Pharmaceutical Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic Idiopathic Constipation (CIC) patients.

Official TitleA Randomized, Double-blind, Placebo-controlled, Phase II Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)
NCT01600001
Principal SponsorKissei Pharmaceutical Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ConstipationDigestive System DiseasesGastrointestinal DiseasesSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and Symptoms

Criteria

2 inclusion criteria required to participate
The patients who experienced fewer than three SBMs per week for more than 6 months prior to the enrollment
The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation
3 exclusion criteria prevent from participating
Patients who have secondary constipation caused by systemic disorder
Patients who have organic constipation
Patients who received intestinal resection

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

20% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Group 5

Placebo

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Japan

Tokyo and Other Japanese City, JapanOpen Japan in Google Maps
CompletedOne Study Center