Double-blind placebo-controlled clinical trial of thalidomide for chronic granulomatous disease-associated colitis
Not Applicable
Recruiting
- Conditions
- Chronic granulomatous disease associated colitis
- Registration Number
- JPRN-UMIN000029324
- Lead Sponsor
- ational Center for Child Heath and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients allergic to the drug ingredients 2) Patients with HIV infection 3) Cancer except granuloma 4) Macrophage activating syndrome 5) Any mental problem 6) Pregnant or breast-feeding woman 7) Taking thalidomide or having a history of thalidomide administration 8) Oral, intravenous, or enema administration of steroid within four weeks of providing informed consent 9) Administration of immunomodulator within eight weeks of providing informed consent 10) A history of any biological agent administration 11) Miner who do not have guardian for appropriate administration of investigational agent 12) In certain circumstances that the researchers determined it was not suitable for the research
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ratio of subjects decreasing more than 20 points of Pediatric ulcerative colitis activity index (PUCAI) or being less than 10 of PUCAI score at the end of double-blind trial
- Secondary Outcome Measures
Name Time Method 1) Ratio of subjects being less than 10 of PUCAI score at the end of double-blind trial 2) Ratio of subjects decreasing more than one point of physician's global assessment (PGA) at the end of double-blind trial