UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001818
Receipt No. R000002173
Scientific Title A multicenter randomized controlled trial of steroid maintenance therapy for preventing relapse of autoimmune pancreatitis.
Date of disclosure of the study information 2009/03/31
Last modified on 2016/11/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A multicenter randomized controlled trial of steroid maintenance therapy for preventing relapse of autoimmune pancreatitis.
Acronym A multicenter randomized controlled trial of steroid maintenance therapy for preventing relapse of autoimmune pancreatitis.
Scientific Title A multicenter randomized controlled trial of steroid maintenance therapy for preventing relapse of autoimmune pancreatitis.
Scientific Title:Acronym A multicenter randomized controlled trial of steroid maintenance therapy for preventing relapse of autoimmune pancreatitis.
Region
Japan

Condition
Condition Autoimmune pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficacy and safety of steroid maintenance therapy for autoimmune pancreatitis after induction of remission.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 36-month relapse free rate.
Key secondary outcomes Relapse-free duration, quality of life, and adverse events.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Continuation of steroid maintenance therapy until the 36th month from the start of remission induction therapy.
Interventions/Control_2 Discontinuation of steroid maintenance therapy at the 6th month from the start of remission induction therapy. From 7th to 36th month, closely follow-up without steroid treatment.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Diagnosed as autoimmune pancreatitis by diagnostic criteria proposed by the Japanese Pancreas Society in 2006. Without past treatment.
2) With notification of the diagnosis of autoimmune pancreatitis.
3) 20-79 years old.
4) Performance Status : 0 or 1.
5) With adequate oral intake.
6) With adequate organ functions.
7) Written informed consent.
Key exclusion criteria 1) With steroid treatment within 3 months before the start of remission induction therapy.
2) With uncontrolled infection.
3) With chronic hepatitis B or HBs antigen-positive.
4) With malignant neoplasm.
5) With severe complications.
6) Unsuitable for this clinical trial due to some complications or other critial medical phenomena.
7) Pregnant, breast-feeding, with chance of pregnancy, or expecting to give birth.
8) With severe mental disorders.
9) Judged as being unsuitable for this trial by investigators.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tooru Shimosegawa
Organization Tohoku University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL 022-717-7171
Email suizo@gastroente.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Masamune
Organization Tohoku University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL 022-717-7171
Homepage URL
Email suizo@gastroente.med.tohoku.ac.jp

Sponsor
Institute Division of Gastroenterology, Tohoku University Graduate School of Medicine
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 Kochi Medical School Hospital
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
2009 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://gut.bmj.com/content/early/2016/08/19/gutjnl-2016-312049.long
Number of participants that the trial has enrolled
Results
Between April 2009 and March 2012, 49 patients with AIP were randomly assigned to the maintenance therapy group (n=30) or the cessation group (n=19). Baseline characteristics were not different between the two groups. Relapses occurred within 3?years in 11 out of 19 (57.9%) patients assigned to the cessation group, and in 7 of 30 (23.3%) patients in the maintenance therapy group. The relapse rate over 3?years was significantly lower in the maintenance therapy group than that in the cessation group (p=0.011). The relapse-free survival was significantly longer in the maintenance therapy group than that in the cessation group (p=0.007). No serious corticosteroid-related complications requiring discontinuation of PSL were observed. 
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 Completed
Date of protocol fixation
2009 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 30 Day
Last modified on
2016 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002173

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.