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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003230
Receipt No. 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

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Basic information
Public title Alternative therapy using continuous intravenous administration of adrenomedullin for patients with inflammatory bowel disease
Acronym Continuous intravenous administration of adrenomedullin for patients with inflammatory bowel disease
Scientific Title Alternative therapy using continuous intravenous administration of adrenomedullin for patients with inflammatory bowel disease
Scientific Title:Acronym Continuous intravenous administration of adrenomedullin for patients with inflammatory bowel disease
Region
Japan

Condition
Condition inflammatory bowel disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Efficacy
improvement of clinical severity stage (DAI score or IOIBD score)

Safety
adverse events
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Kitamura
Organization Faculty of Medicine, University of Miyazaki
Division name First Department of Internal Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Miyazaki
TEL 0985-85-0872
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sinya Ashizuka
Organization Faculty of Medicine, University of Miyazaki
Division name First Department of Internal Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Miyazaki
TEL 0985-85-9227
Homepage URL
Email

Sponsor
Institute First Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 宮崎大学医学部附属病院(宮崎県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2009 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 22 Day
Last modified on
2015 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003907

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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