Exploratory study of the efficacy and safety of salazosulfapyridine for immune checkpoint inhibitor related colitis
- Conditions
- immune checkpoint inhibitor related colitis
- Registration Number
- JPRN-jRCTs031210429
- Lead Sponsor
- Yamada Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
1) Diarrhea or bloody stool lasting more than 1 week during immune checkpoint inhibitor (ICI) administration or within 3 months of discontinuation
2) Mayo score 3-10 points and Mayo endoscopic subscore 1 point or higher
3) Age more than 20 years
4) Eastern Cooperative Oncology Group performance status 0-2
5) Written informed consent was obtained from patient after providing a detailed explanation of the clinical study prior to registration
1) Colonoscopic findings clearly indicate that the cause is another disease
2) A history of inflammatory bowel disease
3) Concomitant use of prohibited drugs
4) Using or planning to use steroids during 1 week before registration or 2 weeks after registration
5) Complicated or suspected toxic megacolon or gastrointestinal perforation
6) Complications of other poorly controlled irAEs at the time of registration
7) Severe liver disease (AST or ALT >100 IU/L)
8) Severe kidney disease (serum creatinine >2 mg/dl)
9) History of hypersensitivity to sulfa drugs or salicylic acid products
10) Poorly controlled bronchial asthma (rpeated asthma attacks within a month)
11) Pegnant or may become pregnant female
12) Lctating female
13) Participation in the clinical trial is determined as unsuitable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with improved clinical score (difference in partial Mayo score is 1 point or more, or partial Mayo score is less than 1) after 2 weeks of administration
- Secondary Outcome Measures
Name Time Method