UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Oral administration of diclofenac in the prevention of post-ERCP pancreatitis: A double-blind, multicenter study.
Title of the study (Brief title)	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	Hirotoshi Ishiwatari
Organization	Sapporo Medical University
Division name	The 4th department of internal medicine
Address	West 16, South 1, Chuoku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Email	ishihiro@sapmed.ac.jp

Public contact
Name of contact person	Yuko Iwaizumi
Organization	Sapporo Medical University
Division name	The 4th department of internal medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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