Alternative therapy using continuous intravenous administration of adrenomedullin for patients with inflammatory bowel disease
Phase 2
- Conditions
- inflammatory bowel disease
- Registration Number
- JPRN-UMIN000003230
- 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 continuing
- 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 severity stage (DAI score or IOIBD score) Safety adverse events
- Secondary Outcome Measures
Name Time Method 1. changes of total and each score of DAI score or IOIBD score 2. changes of clinical severity stage 3. findings of colon fiberscope 4. QOL (IBDQ) 5. dosage of steroid 6. remission in clinical assessment and/or fiberscope findings 7. efficacy, safety, limits for application, and burden of the patients