UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002369 |
|---|---|
| Receipt number | R000002908 |
| Scientific Title | Clinical trial on efficacy and safety of long-term Rebamipide therapy for successful eradication of Helicobacter pylori. |
| Date of disclosure of the study information | 2010/01/01 |
| Last modified on | 2015/06/12 13:44:40 |
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Basic information
Public title
Clinical trial on efficacy and safety of long-term Rebamipide therapy for successful eradication of Helicobacter pylori.
Acronym
Efficacy of rebamipide for gastritis after eradication of Helicobacter pylori.
Scientific Title
Clinical trial on efficacy and safety of long-term Rebamipide therapy for successful eradication of Helicobacter pylori.
Scientific Title:Acronym
Efficacy of rebamipide for gastritis after eradication of Helicobacter pylori.
Region
| Japan |
Condition
Condition
Patients who successful eradication therapy of Helicobacter pylori.
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of our study is to investigate efficacy in long term rebamipide therapy for prevention of histological gastritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of histological gastritis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment group receive rebamipide 300mg three times daily for 1 year.
Interventions/Control_2
control group do not receive rebamipide.
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
Patient who fills everything the following
1) Helicobacter pylori-positive patient.
2) Patient of 20 years or more
3) Early gastric cancer, planning to have endoscopic treatment.
4) Patient who gives written informed consent
Key exclusion criteria
1) Subjects with malignancy
2) Drug allergy
3) Severe complication
4) take non-steroidal inflammatory drugs
5) H. pylori eradication failure after first and second-line therapy.
6) Cases with unsuitable recognition by doctors
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Haruma |
Organization
Kawasaki Medical School
Division name
Department of Internal Medicine, division of Gastroenterology
Zip code
Address
577 Matsushima, Kurashiki, Okayama, 701-0192, Japan,
TEL
086-462-1111
tkamada@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoari Kamada |
Organization
Kawasaki Medical School
Division name
Department of Internal Medicine, division of Gastroenterology
Zip code
Address
577 Matsushima, Kurashiki, Okayama, 701-0192, Japan,
TEL
086-462-1111
Homepage URL
tkamada@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, division of Gastroenterology
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine, division of Gastroenterology
Kawasaki Medical School
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 | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 23 | Day |
Last modified on
| 2015 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002908
