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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000008109
Receipt No. R000009519
Scientific Title Oral administration of diclofenac in the prevention of post-ERCP pancreatitis: A double-blind, multicenter study.
Date of disclosure of the study information 2012/07/01
Last modified on 2016/08/15

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Basic information
Public title Oral administration of diclofenac in the prevention of post-ERCP pancreatitis: A double-blind, multicenter study.
Acronym DBT of diclofenac in the prevention of post-ERCP pancreatitis.
Scientific Title Oral administration of diclofenac in the prevention of post-ERCP pancreatitis: A double-blind, multicenter study.
Scientific Title:Acronym DBT of diclofenac in the prevention of post-ERCP pancreatitis.
Region
Japan

Condition
Condition post-ERCP pancreatitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of diclofenac in prevention of post-ERCP pancreatitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence rate of post-ERCP pancreatitis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Diclofenac group is orally administered with 50mg diclofenac before and after ERCP.
Interventions/Control_2 placebo group is orally administered with capsule filled with lactose before and after ERCP.
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) age>20.
2) body weight >50kg.
3) Patients without sphincter of oddi dysfunction.
Key exclusion criteria 1) Patients with hypersensitivity to diclofenac.
2) Patients with performance status 4.
3) Patients who are treated with diclofenac or received diclofenac within a week.
4) Patients with a history of EST and EPBD.
5) Patients with Vater tumor
6) Patients with divism
7) Patients with chronic pancreatitis
8) Patients with biliary pancreatitis
9) Patients who are judged inappropriate by chief (responsive) medical examiner.
Target sample size 430

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotoshi Ishiwatari
Organization Sapporo Medical University
Division name The 4th department of internal medicine
Zip code
Address West 16, South 1, Chuoku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Email ishihiro@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Iwaizumi
Organization Sapporo Medical University
Division name The 4th department of internal medicine
Zip code
Address West 16, South 1, Chuoku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Homepage URL
Email yuko-iwa@sapmed.ac.jp

Sponsor
Institute The 4th department of internal medicine, Sapporo Medical University
Institute
Department

Funding Source
Organization Sapporo Medical 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
2012 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2011 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 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
2012 Year 06 Month 05 Day
Last modified on
2016 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009519

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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