Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)
- Registration Number
- NCT02281630
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 388
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 Placebo Placebo - KWA-0711 Low dose KWA-0711 - KWA-0711 High dose KWA-0711 -
- Primary Outcome Measures
Name Time Method Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1 1 week
- Secondary Outcome Measures
Name Time Method Stool consistency 4 weeks Degree of straining 4 weeks Complete SBM (CSBM) frequency and responder rate 4 weeks SBM frequency and responder rate 4 weeks Time to first SBM after the initial dose 4 weeks Abdominal bloating and discomfort 4 weeks Use of rescue medications 4 weeks Global assessment of constipation severity 4 weeks Japanese version of IBS-QOL 4 weeks Global assessment of treatment effectiveness 4 weeks Satisfaction rating for the condition of bowel movements 4 weeks Adverse events, ECGs, vital signs, and clinical labs 4 weeks