UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003001 |
|---|---|
| Receipt number | R000003636 |
| Scientific Title | The evaluation of healing effect of Rebamipide for patients with artificial ulcer after ESD |
| Date of disclosure of the study information | 2010/01/09 |
| Last modified on | 2010/01/08 22:58:48 |
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Basic information
Public title
The evaluation of healing effect of Rebamipide for patients with artificial ulcer after ESD
Acronym
The evaluation of healing effect of Rebamipide for patients with artificial ulcer after ESD
Scientific Title
The evaluation of healing effect of Rebamipide for patients with artificial ulcer after ESD
Scientific Title:Acronym
The evaluation of healing effect of Rebamipide for patients with artificial ulcer after ESD
Region
| Japan |
Condition
Condition
early gastric cancers treated by ESD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of a combination of rebamipide and PPI in comparison to PPI alone on artificial ulcer healing after ESD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The progressing ratio to the Scar-stage and ulcer residual ratio between 2 and 56 days after ESD compared with the PPI and the combination group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and 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
The PPI group administered with rabeprazole 20mg daily for 8 weeks
Interventions/Control_2
The combination group administered rebamipide 300mg daily for 8 weeks with rabeprazole 20mg daily.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
differenciated gastric cancers with no lymphatic -vascular involvement corrlating with a normal risk of lymph node metastasis were defined as: mucosal cancer without ulcer findings irrespective of tumor size; mucosal cancer with ulcer findings less than 30mm in diameter
Key exclusion criteria
EGCs which did not fall into one of the categories were excluded from the study and the patients were urged to receive a gastrectomy with removal of lymph nodes.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Azuma |
Organization
Kobe University, School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
7-5-1, kusunoki-cho,chuo-ku, Kobe city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University, School of Medicine
Division name
Institutional Review Board
Zip code
Address
TEL
078-382-6669
Homepage URL
Sponsor or person
Institute
Kobe University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University, School of Medicine
Organization
Division
Category of Funding Organization
Other
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 | 09 | 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
| 2006 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 08 | Day |
Last modified on
| 2010 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003636
