A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of S-297995 for the Treatment of Opioid-induced Constipation (OIC) in Cancer Patients
Phase 2
- Conditions
- Cancer patients with constipation associated with administration of opioid analgesics
- Registration Number
- JPRN-jRCT2080221471
- Lead Sponsor
- SHIONOGI & CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 212
Inclusion Criteria
Cancer patients with constipation associated with administration of opioid analgesics who meet the following criteria:
Patients whose SBM (spontaneous bowel movement) frequency is less than three times per week during the 14 days prior to enrollment, and who experience at least one of the following symptoms of bowel movements;
1. Straining during bowel movement
2. Feeling of incomplete evacuation
3. Passage of hard stools or pellets
etc.
Exclusion Criteria
Patients with constipation potentially attributable to causes other than opioid analgesics
Patients with hepatic or renal disorders, etc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method