Unique ID issued by UMIN | UMIN000003230 |
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Receipt number | R000003907 |
Scientific Title | Alternative therapy using continuous intravenous administration of adrenomedullin for patients with inflammatory bowel disease |
Date of disclosure of the study information | 2010/02/22 |
Last modified on | 2015/03/17 15:11:24 |
Alternative therapy using continuous intravenous administration of adrenomedullin for patients with inflammatory bowel disease
Continuous intravenous administration of adrenomedullin for patients with inflammatory bowel disease
Alternative therapy using continuous intravenous administration of adrenomedullin for patients with inflammatory bowel disease
Continuous intravenous administration of adrenomedullin for patients with inflammatory bowel disease
Japan |
inflammatory bowel disease
Gastroenterology |
Others
NO
Inflammatory bowel disease (IBD, ulcerative colitis and Crohn disease) is still to be accounted for causes and cannot reach total cure, so therapeutic goal of the IBD is maintaining the remission for social activity. Steroid is still effective and reliable for introduction of the remission, but prolonged-administration of the steroid induces severe side effects and declines in QOL of the patients. So total amount of the steroid must be limited minimum, but efficacy of other drugs is insecure. Alternative approach for the treatment of the IBD is wanted, and adrenomedullin (AM) is attractive candidate of the purpose because AM has anti-inflammatory effects in experimental model rats of IBD. In this study, we will explore the efficacy and safety of continuous intravenous administration of AM in the patients with IBD.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Efficacy
improvement of clinical severity stage (DAI score or IOIBD score)
Safety
adverse events
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
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)
20 | years-old | <= |
Not applicable |
Male and Female
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
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
10
1st name | |
Middle name | |
Last name | Kazuo Kitamura |
Faculty of Medicine, University of Miyazaki
First Department of Internal Medicine
5200 Kihara, Kiyotake, Miyazaki, Miyazaki
0985-85-0872
1st name | |
Middle name | |
Last name | Sinya Ashizuka |
Faculty of Medicine, University of Miyazaki
First Department of Internal Medicine
5200 Kihara, Kiyotake, Miyazaki, Miyazaki
0985-85-9227
First Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Ministry of Health, Labour and Welfare
Japan
NO
宮崎大学医学部附属病院(宮崎県)
2010 | Year | 02 | Month | 22 | Day |
Unpublished
No longer recruiting
2009 | Year | 11 | Month | 02 | Day |
2010 | Year | 03 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 06 | Month | 01 | Day |
2010 | Year | 02 | Month | 22 | Day |
2015 | Year | 03 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003907
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