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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012964
Receipt No. 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

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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
Email 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
Email m1151329@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015156

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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