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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001215
Receipt No. 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

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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
Email 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
Email miwa-sec@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine Upper gastroenterology Department of internal medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001472

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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