UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022633 |
|---|---|
| Receipt number | 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 19:48:35 |
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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
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
mm2043st@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025723
