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

Chronic Idiopathic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600001
• Other study ID #: KWA1201
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2012
• Last updated: October 29, 2013

Study information

• Verified date: October 2013
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Drug:
• KWA-0711

• Placebo

Locations

Country	Name	City	State
Japan	Japan	Tokyo and Other Japanese City

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of signs and symptoms associated with constipation		4 weeks	No