A Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)
- 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
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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which KWA-0711 modulates gastrointestinal motility in CIC patients?
How does KWA-0711 compare to PEG or linaclotide in terms of efficacy and safety for CIC treatment?
Are there specific biomarkers associated with response to KWA-0711 in chronic idiopathic constipation?
What adverse events are commonly reported with KWA-0711 and how are they managed in clinical practice?
What other investigational drugs or combination therapies are being developed for CIC by Kissei Pharmaceutical Co., Ltd.?
Trial Locations
- Locations (1)
Japan
🇯🇵Tokyo and Other Japanese City, Japan
Japan🇯🇵Tokyo and Other Japanese City, Japan