UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002068 |
|---|---|
| Receipt number | R000002522 |
| Scientific Title | Effectiveness of rebamipide for human gastric membrane after distal gastrectomy |
| Date of disclosure of the study information | 2009/06/11 |
| Last modified on | 2016/06/15 11:51:58 |
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Basic information
Public title
Effectiveness of rebamipide for human gastric membrane after distal gastrectomy
Acronym
rebamipide trial for gastritis after distal gastrectomy
Scientific Title
Effectiveness of rebamipide for human gastric membrane after distal gastrectomy
Scientific Title:Acronym
rebamipide trial for gastritis after distal gastrectomy
Region
| Japan |
Condition
Condition
Gastritis in remnant stomach
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To avoid gastritis in remnant stomach, rebamipide will protect the inflammatory change of the membrane.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Patient number with gastritis or inflammatory change in remnant stomach
Key secondary outcomes
Loss of body weight
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Rebamipide 300mg per day for a year
Interventions/Control_2
No treatment
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
Patient who underwent distal gastrectomy
Key exclusion criteria
1.Patients treated with gastric secretion inhibitor in a month prior to this study.
2.Patients with thoracotomy, hepatectomy, pancreatomy or colectomy.
3.Patients with other malignancy.
4.Patients with cardiac, hepatic or hematologic disease.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisahiro Matsubara |
Organization
Chiba University Graduate School of Medicine
Division name
Frontier Surgery
Zip code
Address
1-8-1, Inohana, Chuouku,Chiba
TEL
043-222-7171
hk@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kawahira |
Organization
Chiba University Graduate School of Medicine
Division name
Frontier Surgery
Zip code
Address
1-8-1, Inohana, Chuouku,Chiba
TEL
043-222-7171
Homepage URL
hk@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Scholarship donation
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
| 2009 | Year | 06 | Month | 11 | 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
| 2009 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 06 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 11 | Day |
Last modified on
| 2016 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002522
