UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003230
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

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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