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


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 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


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

Value
https://center6.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