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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028900
Receipt No. R000033072
Scientific Title Prospective trial on the safety of rectal indomethacin 100mg for prophylaxis of post endoscopic retrograde cholangiopancreatography pancreatitis for Japanese.
Date of disclosure of the study information 2017/09/01
Last modified on 2018/12/09

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Basic information
Public title Prospective trial on the safety of rectal indomethacin 100mg for prophylaxis of post endoscopic retrograde cholangiopancreatography pancreatitis for Japanese.
Acronym Trial on the safety of rectal indomethacin 100mg.
Scientific Title Prospective trial on the safety of rectal indomethacin 100mg for prophylaxis of post endoscopic retrograde cholangiopancreatography pancreatitis for Japanese.
Scientific Title:Acronym 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
1st name
Middle name
Last name Satoshi Asai
Organization Tane General Hospital
Division name Department of Gastroenterology
Zip code
Address 1-12-21 Kujouminami Nishiku Osaka, Japan
TEL 06-6581-1071
Email satoshi.asai@tane.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Takeshita
Organization Tane General Hospital
Division name Department of Gastroenterology
Zip code
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)

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
2017 Year 09 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 28 Day
Date of IRB
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

Other
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

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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