To evaluate the efficacy and safety of 14-day multiple oral doses of S-297995 in cancer patients with opioid analgesic-induced constipation in the multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Pharmacokinetics are also assessed.
Not Applicable
Completed
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0000409
- Lead Sponsor
- Shionogi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Cancer patients with constipation associated with administration of opioid analgesics who meet the following criteria:
Patients whose SBM (spontaneous bowel movement) frequency during the 14 days prior to enrollment is 5 times or less, and who experience at least one of the following symptoms of bowel movements
- Straining during bowel movement
- Feeling of incomplete evacuation
- Passage of hard stools or pellets etc.
Exclusion Criteria
Patients with constipation potentially attributable to causes other than opioid analgesics
Patients with clinically significant gastrointestinal disorders
Patients with hepatic or renal disorders, etc
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of S-297995 with that of placebo using the change in the frequency of spontaneous bowel movements per week from the baseline during 14-days once-daily oral administration.
- Secondary Outcome Measures
Name Time Method