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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016274
Receipt No. R000018884
Scientific Title effectiveness of prophylaxis of post-ercp pancreatitis by a rectal diclofenac and sublingual nitrate.-randomized controlled multicenter trial-
Date of disclosure of the study information 2015/02/05
Last modified on 2018/07/04

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Basic information
Public title effectiveness of prophylaxis of post-ercp pancreatitis by a rectal diclofenac and sublingual nitrate.-randomized controlled multicenter trial-
Acronym a randomized trial of rectal diclofenac and sublingual nitrate for prevention of post ercp pancreatitis
Scientific Title effectiveness of prophylaxis of post-ercp pancreatitis by a rectal diclofenac and sublingual nitrate.-randomized controlled multicenter trial-
Scientific Title:Acronym a randomized trial of rectal diclofenac and sublingual nitrate for prevention of post ercp pancreatitis
Region
Japan

Condition
Condition Post-ERCP pancretitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to evaluate the effi cacy
of rectally administered diclofenac plus sublingual nitrate compared with diclofenac alone to prevent post-ERCP panceatitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence rate of post-ERCP pancreatitis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 patients received a 5mg
of sublingual nitrate before ERCP and received a suppository containing 50mg of diclofenac after ERCP.
Interventions/Control_2 patients received a suppository containing 50mg of diclofenac after ERCP.
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 ERCP
Key exclusion criteria 1)Patients with performance status 4.
2)Age<20
3)Body weight<50Kg
4)Patients who cannot access to Vater,s papilla.
5)Patients with a history of EST and EPBD.
6)Patients with acute pancreatitis
7)Patients with chronic pancreatitis
8)Patients with pancreatic head tumor
9)Patients who performed operation of reconstraction for intestinal track by gastrectomy.
10) Patients who had a contraindication
to the use of NSAIDs and nitrate.
11) Patients who were already taking nitrates.
12)Patietns without informed concent.
13)Patients who are judged inappropriate by chief medical examiner.
Target sample size 900

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironari Kato
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Gastroenterology & Hepatology
Zip code
Address 2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL 086-235-7219
Email drkatocha@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Tomoda
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Gastroenterology & Hepatology
Zip code
Address 2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL 086-235-7219
Homepage URL
Email tomotake79@yahoo.co.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
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
2015 Year 02 Month 05 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
2015 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 18 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
2015 Year 01 Month 20 Day
Last modified on
2018 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018884

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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