UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007467 |
|---|---|
| Receipt number | R000008805 |
| Scientific Title | The prevntional effect of celecoxib on acute pancreatitis after endoscopic retrograde cholangiopancreatography. |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2018/03/12 09:27:42 |
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Basic information
Public title
The prevntional effect of celecoxib on acute pancreatitis after endoscopic retrograde cholangiopancreatography.
Acronym
The preventional effect of celecoxib on acute pancreatitis after endoscopic retrograde cholangiopancreatography.
Scientific Title
The prevntional effect of celecoxib on acute pancreatitis after endoscopic retrograde cholangiopancreatography.
Scientific Title:Acronym
The preventional effect of celecoxib on acute pancreatitis after endoscopic retrograde cholangiopancreatography.
Region
| Japan |
Condition
Condition
acute pancreatitis after endoscopic retrograde cholangiopancreatography
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will invesigate the preventional effect of celecoxib on acute pancreatitis after endoscopic retrograde cholangiopancreatography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1:incidence rate of acute pancreatitis
2:serum amylase level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
celecoxib fo oral administration
Interventions/Control_2
no treatment
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
all patients who are examined endoscopic retrograde cholangiopancreatography
Key exclusion criteria
digestive organ ulcer
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Adachi Tomohiko |
Organization
Nagasaki University
Division name
department of surgery
Zip code
Address
1-7-1 Sakamoto Nagasaki
TEL
095-819-7316
adatomo-ngs@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Adachi |
Organization
University of Nagasaki
Division name
department surgery
Zip code
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7316
Homepage URL
adatomo@nifty.com
Sponsor or person
Institute
Depatment of surgery
University of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 04 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 07 | Day |
Last modified on
| 2018 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008805
