UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028900
Receipt number 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 11:02:08

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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 or person

Institute

Tane General Hospital

Department of Gastroenterology

Institute

Department

Personal name



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

Value
https://center6.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