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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004592
Receipt No. R000005423
Scientific Title Multicenter, placebo-controlled randomized trial for prevention of post ERCP pancreatitis with Risperidone
Date of disclosure of the study information 2010/12/01
Last modified on 2012/10/26

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Basic information
Public title Multicenter, placebo-controlled randomized trial for prevention of post ERCP pancreatitis with Risperidone
Acronym Tokyo P3R-2
Scientific Title Multicenter, placebo-controlled randomized trial for prevention of post ERCP pancreatitis with Risperidone
Scientific Title:Acronym Tokyo P3R-2
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, placebo-controlled study is to evaluate the efficacy and safety of Risperidone for prevention of post ERCP pancreatitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The primary endpoints are frequency and severity of post ERCP pancreatitis.
Post ERCP pancreatitis is defined according to Consensus Guideline (by Cotton Classification) published in 1991 as follows.
1)Serum amylase level that is three times higher than normal upper limit.
2)Abdominal pain persisting for at least 24 hours.
Key secondary outcomes 1) Change in serum amylase, pancreatic amylase, and lipase
2) The incidence of abdominal pain and hyperenzymemia.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Risperidone group is orally administered with 2 capsules filled with 1mg risperidone and lactose 50 to 120 minutes before ERCP.
Interventions/Control_2 Placebo group is administered orally with 2 capsules filled with lactose 50 to 120 minutes before 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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who are planned to undergo first ERCP. Written informed consent is obtained from patient before the study.
Key exclusion criteria Patients with a history of ERCP.
Patients with acute pancreatitis which need fasting therapy.
Patients who have disseminated intravascular coagulation, sepsis, or acute circulatory failure.
Patients with more severe disturbance of consciousness than Japan Coma Scale1-1.
Patients who have severe heart disease, hepatic insufficiency, renal dysfunction, endocrine disease, or gastrointestinal tract disturbance.
Pregnant or breast-feeding women. Women who have possibility of pregnancy or who are not willing to avoid pregnancy during the study.
Patients who are treated with risperidone.
Patients with severe hypersensitivity to risperidone
Patients with mental illness or depression, who need drug therapy or can not comply with the protocol.
Patients with Parkinson's disease or parkinsonism.
Patients who have received banned drug within 2 weeks before ERCP
Patients with chronic pancreatitis
Patients who are judged inappropriate by chief (responsive) medical examiner
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization Faculty of Medicine, University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Isayama
Organization Faculty of Medicine, University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Faculty of Medicine, University of Tokyo
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
2010 Year 12 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 Completed
Date of protocol fixation
2010 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2012 Year 10 Month 06 Day
Date of closure to data entry
2012 Year 10 Month 18 Day
Date trial data considered complete
2012 Year 10 Month 20 Day
Date analysis concluded
2012 Year 10 Month 25 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 19 Day
Last modified on
2012 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005423

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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