UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001215 |
|---|---|
| Receipt number | R000001472 |
| Scientific Title | Controlled comparative study for the efficacy between famotidine and omeprazole on prevention of delayed bleeding from ulcer after ESD for early gastric cancer |
| Date of disclosure of the study information | 2008/06/30 |
| Last modified on | 2014/07/01 16:11:12 |
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Basic information
Public title
Controlled comparative study for the efficacy between famotidine and omeprazole on prevention of delayed bleeding from ulcer after ESD for early gastric cancer
Acronym
Effect of H2RA and PPI on prevention of bleeding after ESD for early gastric cancer
Scientific Title
Controlled comparative study for the efficacy between famotidine and omeprazole on prevention of delayed bleeding from ulcer after ESD for early gastric cancer
Scientific Title:Acronym
Effect of H2RA and PPI on prevention of bleeding after ESD for early gastric cancer
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy between famotidine and omeprazole on prevention of delayed bleeding from ulcer after ESD for early gastric cancer by single-blined-control method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Retio of delayed bleeding(hematemesis or melena required endoscopic hemostasis, decreased the hemoglobin count by more than 2g/dl)
Key secondary outcomes
The curative rate for ulcer after ESD at 6 weeks later
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of famotidine 40mg P.O./day for 8weeks
Interventions/Control_2
Administration of famotidine 40mg P.O./day for 1day and omeprazole 40mg I.V./day for 3days after ESD and omeprazole 20mg P.O./day for 7weeks and 4 days
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. early gastric cancer patients who undergo ESD
2. patients who are older than 20 years at entry.
3. patients who understand the study contents and give informed consents by themselves
Key exclusion criteria
1. patients with severe liver, renal and cardiopulumonary diseases.
2. patients who took medicines described below within one week before the first day of the study; H2RA, PPI
3. patients who had underwent eradication therapy for H.pylori within 6 months before the first day of the study
4. patients who are pregnancy, in breast-feeding or who wish pregnancy during the study period.
5. patients who are regarded in-eligible by the doctor who participates in this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto Miwa |
Organization
Hyogo College of Medicine
Division name
Upper gastroenterology Department of internal medicine
Zip code
Address
1-1, Mukogawa-cho Nishinomiya
TEL
0798-45-6665
miwahgi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yongmin Kim |
Organization
Hyogo College of Medicine
Division name
Upper gastroenterology Department of internal medicine
Zip code
Address
1-1, Mukogawa-cho Nishinomiya
TEL
0798-45-6665
Homepage URL
miwa-sec@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine Upper gastroenterology Department of internal medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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 | 06 | Month | 30 | 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
| 2008 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 27 | Day |
Last modified on
| 2014 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001472
