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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
