UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004592 |
|---|---|
| Receipt number | 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 21:46:51 |
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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
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
Sponsor or person
Institute
Faculty of Medicine, University of Tokyo
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005423
