UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012964 |
|---|---|
| Receipt number | R000015156 |
| Scientific Title | Randomized trial for prevention of post ERCP pancreatitis with celecox tablets |
| Date of disclosure of the study information | 2014/01/27 |
| Last modified on | 2017/01/28 09:47:16 |
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Basic information
Public title
Randomized trial for prevention of post ERCP pancreatitis with celecox tablets
Acronym
Randomized trial for prevention of post ERCP pancreatitis with celecox tablets
Scientific Title
Randomized trial for prevention of post ERCP pancreatitis with celecox tablets
Scientific Title:Acronym
Randomized trial for prevention of post ERCP pancreatitis with celecox tablets
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 randomized study is to evaluate the efficacy and safety of Celecox tablets for prevention of post ERCP pancreatitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoints are frequency of post ERCP pancreatitis.
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
control group(Non-administration of celecox tablets)
Interventions/Control_2
celecox tablets administered before ERCP group
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
Patients who are planned to perform ERCP for further evaluation or treatment. Written informed consent is obtained from patient before the study.
Key exclusion criteria
Patients who have severe heart disease, hepatic insufficiency, renal dysfunction, endocrine disease, or gastrointestinal tract disturbance.
Patients with acute or chronic pancreatitis which need fasting therapy.
Patients who take NSAIDs usually.
Patients with a history of asthma of aspirin and allergia of iodine.
Patients who performed operation of reconstraction for intestinal track by gastorectomy.
Patients without informed consent.
Patients who are judged inappropriate by chief (responsive) medical examiner.
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Sugimori |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of gastroenterological medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3811
m1151329@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Sugimori |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of gastroenterological medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3811
Homepage URL
m1151329@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
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
| 2014 | Year | 01 | Month | 27 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 26 | Day |
Last modified on
| 2017 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015156
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
