UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011322 |
|---|---|
| Receipt number | R000013267 |
| Scientific Title | Low dose flurbiprofen for prevention of postendoscopic retrograde cholangiopancreatography pancreatitis |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2017/08/16 19:19:12 |
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Basic information
Public title
Low dose flurbiprofen for prevention of postendoscopic retrograde cholangiopancreatography pancreatitis
Acronym
Low dose flurbiprofen for prevention of post endoscopic retrograde cholangiopancreatography pancreatitis
Scientific Title
Low dose flurbiprofen for prevention of postendoscopic retrograde cholangiopancreatography pancreatitis
Scientific Title:Acronym
Low dose flurbiprofen for prevention of post endoscopic retrograde cholangiopancreatography pancreatitis
Region
| Japan |
Condition
Condition
all desease that is needed ERCP
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of validity to the prevention of pancreatitis by Low-dose flurbiprofen
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Does pancreatitis happened post ERCP or not
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients who were scheduled to undergo ERCP were receive 50 mg of flurbiprofen infusion. The dose of flurbiprofen was reduced to 25 mg in patients weighing<50 kg
Interventions/Control_2
A medicine is not prescribed for the patient.
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)older than 20years old
2)the patient performed ERCP
3) The patient who understands the details of this research and by whom the consent of research participation is got from himself/herself with a document
Key exclusion criteria
1) acute or active pancreatitis
2)metalicstent was inserted across the papilla
3)history of endoscopic sphincterotomy
4) peptic ulcer diseases
5) aspirin-induced asthma
6) NSAIDs during the preceding 1 week
7) hypersensitivity to NSAIDs
8) pregnant or breast-feeding
9) severe renal dysfunction,
10) the patient whom the doctor in attendance judged to be unsuitable
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Fujita |
Organization
YOKOHAMA CITY UNIVERSITY HOSPITAL
Division name
Gastroenterology
Zip code
Address
3-9 fukuura kanazawa-ku yokohamacity
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
YOKOHAMA CITY UNIVERSITY HOSPITAL
Division name
Gastroenterology
Zip code
Address
TEL
045-787-2800
Homepage URL
Sponsor or person
Institute
YOKOHAMA CITY UNIVERSITY HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2013 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | 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
| 2013 | Year | 07 | Month | 30 | Day |
Last modified on
| 2017 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013267
