A Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)

Phase 2

Completed

• Conditions: Chronic Idiopathic Constipation
• Interventions: Drug: KWA-0711; Drug: Placebo

• Registration Number: NCT01600001
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-16
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 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

Exclusion Criteria

• Patients who have secondary constipation caused by systemic disorder
• Patients who have organic constipation
• Patients who received intestinal resection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug:KWA-0711 dose 1	KWA-0711	-
Drug:KWA-0711 dose 2	KWA-0711	-
Drug:KWA-0711 dose 3	KWA-0711	-
Drug:KWA-0711 dose 4	KWA-0711	-
Drug: Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Improvement of signs and symptoms associated with constipation	4 weeks

Trial Locations

Locations (1)

Japan; 🇯🇵 Tokyo and Other Japanese City, Japan