UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001316 |
|---|---|
| Receipt number | 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 21:39:01 |
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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
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
Sponsor or person
Institute
Faculty of Mediceine, 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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001491
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
