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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011322
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute YOKOHAMA CITY UNIVERSITY HOSPITAL
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013267

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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