inflammatory bowel disease
Conditions
Interventions
Period up to 2 weeks (14 days) Drug dose continuous intravenous administration of adrenomedullin 1.5 pmol/kg/min for 8 hours per day (09:00 to 17:00)
Sponsors
First Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with inflammatory bowel disease (IBD) fall under any of following conditions 1. uncontrollable with 5-aminosaritilic acid and cannot use steroid by any reasons 2. intractable patients by steroid resistance and relative adaptation of operation 3. intractable patients by steroid dependency and relative adaptation of operation
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy improvement of clinical severity stage (DAI score or IOIBD score) Safety adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactSinya Ashizuka
Faculty of Medicine, University of Miyazaki First Department of Internal Medicine
Outcome results
None listed