UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective trial on the safety of rectal indomethacin 100mg for prophylaxis of post endoscopic retrograde cholangiopancreatography pancreatitis for Japanese.
Title of the study (Brief title)	Trial on the safety of rectal indomethacin 100mg.
Region	Japan

Condition
Condition	post ERCP pancreatitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this trial is to confirm the safety of rectal indomethacin 100mg for the prophylaxis of post ERCP pancreatitis for Japanese population as a pilot single arm prospective trial before large scale trial in the future.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	rate of adverse event
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	preprocedural rectal indomethacin 100mg all at once
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	19 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	patients who undergo ERCP related procedure
Key exclusion criteria	1 patients who are contraindicated of rectal indomethacin according to the drug information ex.) gastrointestinal ulcer, severe commorbidity(hematologic disease, liver dysfunction, renal disorder, heart failure, hypertention) history of hypersensitivity to salicylic acid-based compound procitis, rectal bleeding or hemorrhoid aspirin-induced asthma pregnancy 2 patients who don't agree to perticipate in this trial
Target sample size	100

Research contact person
Name of lead principal investigator	Satoshi Asai
Organization	Tane General Hospital
Division name	Department of Gastroenterology
Address	1-12-21 Kujouminami Nishiku Osaka, Japan
TEL	06-6581-1071
Email	satoshi.asai@tane.or.jp

Public contact
Name of contact person	Kotaro Takeshita
Organization	Tane General Hospital
Division name	Department of Gastroenterology
Address	1-12-21 Kujouminami Nishiku Osaka, Japan
TEL	06-6581-1071
Homepage URL
Email	karaagrkun@hotmail.com

Sponsor
Institute	Tane General Hospital Department of Gastroenterology
Institute
Department

Funding Source
Organization	nothing
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	2017 Year 09 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 28 Day
Anticipated trial start date	2017 Year 09 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 30 Day
Last modified on	2018 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033072