Status:
COMPLETED
Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Conditions:
Chronic Constipation
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose in Chronic Constipation (CC) patients.
Eligibility Criteria
Inclusion
- 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
- Patients who have secondary constipation caused by systemic disorder.
- Patients who have organic constipation.
- Patients who received intestinal resection.
Key Trial Info
Start Date :
October 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT02281630
Start Date
October 15 2014
Last Update
May 22 2017
Active Locations (1)
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1
Tokyo and Other Japanese City, Japan