UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001316
Receipt No. R000001491
Scientific Title Multicenter randomized trial of the prevention of gastric mucosal injury with Rabeprazol in chemotherapeutic cases of pancreatic cancer
Date of disclosure of the study information 2008/08/20
Last modified on 2008/08/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multicenter randomized trial of the prevention of gastric mucosal injury with Rabeprazol in chemotherapeutic cases of pancreatic cancer
Acronym G-RAP Test
Scientific Title Multicenter randomized trial of the prevention of gastric mucosal injury with Rabeprazol in chemotherapeutic cases of pancreatic cancer
Scientific Title:Acronym G-RAP Test
Region
Japan

Condition
Condition Pancreatic Cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy of Rabeprazole in chemotherapeutic cases of pancreatic cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Modified Lanza score
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A:Rabeprazole(10mg/Day)adiminisitration between 8weeks
Interventions/Control_2 B:Without administration of any kind of PPI or H2RA
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 1 Patients who were diagnosed with pancreatic cancer and will receive chomothrapy of GEM or GEM+TS-1
2 Patients more than equal 20 years old
3 Patients who can decide themselves
Key exclusion criteria 1 Patients with gastric ulcer or esophagial varices
2 Lanza score, greater or equal 2
3 Direct invasion to gastric or duodenal mucosa
4 Patients who have the symptom of abdominal pain or heartburn
5 Patients who take NSAIDs or steroids
6 Patients who had taken PPI or H2RA within 14 days before start of chemothrapy
7 Patients who had liver chirrosis
8 Patients who ware given gastric resection
9 Performance status, greater or equal 3
10 Patients who had undertaken adverse event caused by PPI
11 Patients who were determined inadequate by doctor
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization Tokyo University Hospital
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 Yoko Yashima
Organization Tokyo University Hospital
Division name Department of gastroenterology
Zip code
Address 7-3-1,Hongo,Bunkyo-ku,Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Faculty of Mediceine, 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
2008 Year 08 Month 20 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
Date of protocol fixation
2007 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2010 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 08 Month 17 Day
Last modified on
2008 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001491

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.