Chronic Constipation
Conditions
Keywords
Chronic Constipation, CC
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.
Interventions
DRUGKWA-0711
DRUGPlacebo
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1 | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| SBM frequency and responder rate | 4 weeks |
| Time to first SBM after the initial dose | 4 weeks |
| Stool consistency | 4 weeks |
| Degree of straining | 4 weeks |
| Abdominal bloating and discomfort | 4 weeks |
| Complete SBM (CSBM) frequency and responder rate | 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 |
| Use of rescue medications | 4 weeks |
Countries
Japan
Outcome results
None listed