Indomethacin oral spray for the analgesic effect of pain reduction in patient with oral mucositis due to cancer therapy: Randomized, double-blind, placebo-controlled phase II trial
Not Applicable
- Conditions
- Patients with oral mucisitis due to cancer therapy
- Registration Number
- JPRN-UMIN000017664
- Lead Sponsor
- on-profit Organization Japanese Organisation for Reserch and Treatment of Cancer (JORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who have experience of IOS 2)Patients who have other important disorder that needs to be prioritized the treatment 3)Allergy due to NSAIDS 4)Patients who are judged to be inappropriate by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brief Pain Inventry(BPI)- item6 change between before(0min) and after IOS treatment(30min).
- Secondary Outcome Measures
Name Time Method 1)Area Under the Curve of BPI-item6 after IOS teatment(0min,15min,60min,120min,180min and 240min) 2)BPI (item3,4,5,6,8) cange between before(0min) and after IOS treatment(24hours) 3)Global impression 4)Minimal clinically important difference 5)Adverse effect