Continuous intravenous adrenomedullin therapy for patients with inflammatory bowel disease (ulcerative colitis and Crohn's disease)
Phase 1
- Conditions
- inflammatory bowel disease (ulcerative colitis and Crohn's disease)
- Registration Number
- JPRN-UMIN000021421
- Lead Sponsor
- First Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
Patients having one or more of following conditions 1. malignancy 2. pre-carcinoma lesion(s) of the intestine 3. recommended early operation 4. cachexia 5. severe liver dysfunction 6. acute myocardial infarction, unstable angina, myocarditis and stroke within 1 month 7. active infection 8. pregnancy 9. other inappropriate conditions by doctor decision
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy improvement of clinical activity score before and after adrenomedullin administration UC: Disease Activity Index score CD: CDAI
- Secondary Outcome Measures
Name Time Method 1. changes of clinical severity, befor and 2weeks, 4weeks, 8weeks after adrenomedullin administration 2. findings of colonoscopy, , befor and 2weeks, 4weeks, 8weeks after adrenomedullin administration 3. dosage of steroid, , befor and 2weeks, 4weeks, 8weeks after adrenomedullin administration 4. blood pressure and hart rate during AM infusion 5. blood examination