UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Continuous intravenous adrenomedullin therapy for patients with inflammatory bowel disease (ulcerative colitis and Crohn's disease)
Title of the study (Brief title)	Adrenomedullin therapy for patients with inflammatory bowel disease
Region	Japan

Condition
Condition	inflammatory bowel disease (ulcerative colitis and Crohn's disease)
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will explore the efficacy and safety of continuous intravenous administration of AM in the patients with refractory inflammatory bowel disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Efficacy improvement of clinical activity score before and after adrenomedullin administration UC: Disease Activity Index score CD: CDAI
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
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. moderately to severe active IBD 2. uncontrollable with conventional therapy (5ASA, corticosteroid, calcineurin inhibitors, biological agents)
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	Kazuo Kitamura
Organization	Faculty of Medicine, University of Miyazaki
Division name	First Department of Internal Medicine
Address	5200 Kihara, Kiyotake, Miyazaki, Miyazaki
TEL	0985-85-0872
Email	kazuokit@med.miyazaki-u.ac.jp

Public contact
Name of contact person	Sinya Ashizuka
Organization	Faculty of Medicine, University of Miyazaki
Division name	First Department of Internal Medicine
Address	5200 Kihara, Kiyotake, Miyazaki, Miyazaki
TEL	0985-85-9227
Homepage URL
Email	shinya_ashizuka@med.miyazaki-u.ac.jp

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	Japanese Governmental office
Nationality of Funding Organization	Japan

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

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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 09 Day
Anticipated trial start date	2016 Year 03 Month 14 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry	2017 Year 06 Month 30 Day
Date trial data considered complete	2017 Year 06 Month 30 Day
Date analysis concluded	2017 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 10 Day
Last modified on	2017 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024707