Unique ID issued by UMIN | UMIN000021421 |
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Receipt number | R000024707 |
Scientific Title | Continuous intravenous adrenomedullin therapy for patients with inflammatory bowel disease (ulcerative colitis and Crohn's disease) |
Date of disclosure of the study information | 2016/03/11 |
Last modified on | 2017/09/11 15:46:57 |
Continuous intravenous adrenomedullin therapy for patients with inflammatory bowel disease (ulcerative colitis and Crohn's disease)
Adrenomedullin therapy for patients with inflammatory bowel disease
Continuous intravenous adrenomedullin therapy for patients with inflammatory bowel disease (ulcerative colitis and Crohn's disease)
Adrenomedullin therapy for patients with inflammatory bowel disease
Japan |
inflammatory bowel disease (ulcerative colitis and Crohn's disease)
Gastroenterology |
Others
NO
We will explore the efficacy and safety of continuous intravenous administration of AM in the patients with refractory inflammatory bowel disease.
Safety,Efficacy
Confirmatory
Pragmatic
Phase I,II
Efficacy
improvement of clinical activity score before and after adrenomedullin administration
UC: Disease Activity Index score
CD: CDAI
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
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. moderately to severe active IBD
2. uncontrollable with conventional therapy (5ASA, corticosteroid, calcineurin inhibitors, biological agents)
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
kazuokit@med.miyazaki-u.ac.jp
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
shinya_ashizuka@med.miyazaki-u.ac.jp
First Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Ministry of Health, Labour and Welfare
Japanese Governmental office
Japan
NO
2016 | Year | 03 | Month | 11 | Day |
Unpublished
Completed
2016 | Year | 03 | Month | 09 | Day |
2016 | Year | 03 | Month | 14 | Day |
2017 | Year | 06 | Month | 30 | Day |
2017 | Year | 06 | Month | 30 | Day |
2017 | Year | 06 | Month | 30 | Day |
2017 | Year | 06 | Month | 30 | Day |
2016 | Year | 03 | Month | 10 | Day |
2017 | Year | 09 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024707
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