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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022633
Receipt No. R000025723
Scientific Title Efficacy and safety of low-dose steroid treatment in asymptomatic patients with autoimmune pancreatitis.
Date of disclosure of the study information 2016/06/06
Last modified on 2016/06/06

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Basic information
Public title Efficacy and safety of low-dose steroid treatment in asymptomatic patients with autoimmune pancreatitis.
Acronym Usefulness of low-dose steroid treatment in patients with autoimmune pancreatitis.
Scientific Title Efficacy and safety of low-dose steroid treatment in asymptomatic patients with autoimmune pancreatitis.
Scientific Title:Acronym Usefulness of low-dose steroid treatment in patients with autoimmune pancreatitis.
Region
Japan

Condition
Condition autoimmune pancreatitis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy of low-dose steroid treatment for asymptomatic patients with autoimmune pancreatitis (AIP) prospectively.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The sequential change of pancreatic exocrine function
Key secondary outcomes

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 Steroid treatment (total 56 weeks)

Induction ~ 4 weeks : Prednisolone 10mg/day
4 weeks ~ 48 weeks : Prednisolone 5mg/day
48 weeks ~ 52 weeks : Prednisolone 2.5mg/day
52 weeks ~ 56 weeks : Prednisolone 1mg/day
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 1) Asymptomatic and untreated patients with AIP diagnosed on the basis of the diagnostic criterion of AIP 2011 published by Japan Pancreas Society
2) Age of 20 and more
3) ECOG performance status of 0 or 1
4) Written informed consent
Key exclusion criteria 1) Patients who have already administered steroid and/or immunosuppressive drugs
2) Severe drug hypersensitivity
3) Active infection
4) Infection of HBV (patients with HBc antigen-positive or with HBs antibody-positive, or patients previously unvaccinated against HBV with HBs antibody-positive alone)
5) Patients who require the treatment of cerebrovascular or cardiovascular disorder
6) Patients with uncontrollable diabetes mellitus
7) Patients with uncontrollable hypertension
8) Patients with severe mental disorder
9) Patients with severe cataract or glaucoma
10) Patients with severe renal disorder
11) Patients with severe lung disorder
12) Patients with severe liver disorder
13) Patients with severe osteoporosis
14) Past history of pancreatectomy
15) Pregnant or lactating women, or women with suspected pregnancy
16) Patients seems inadequate for this study judged by investigators
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3621
Email office@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Suda
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3621
Homepage URL
Email mm2043st@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Osaka University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 06 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 Preinitiation
Date of protocol fixation
2016 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 06 Day
Last modified on
2016 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025723

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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