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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007639
Receipt No. R000009012
Scientific Title Adequate therapy against low-dose aspirin-induced ulcer: comparison of two acid-inhibitory drugs, rabeprazole and famotidine (Quality study)
Date of disclosure of the study information 2012/04/02
Last modified on 2014/04/15

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Basic information
Public title Adequate therapy against low-dose aspirin-induced ulcer: comparison of two acid-inhibitory drugs, rabeprazole and famotidine (Quality study)
Acronym Quality study
Scientific Title Adequate therapy against low-dose aspirin-induced ulcer: comparison of two acid-inhibitory drugs, rabeprazole and famotidine (Quality study)
Scientific Title:Acronym Quality study
Region
Japan

Condition
Condition gastric ulcer during usage of low dose aspirin (80-100 mg/day)
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate which is more effective drug for improvement of low-dose aspirin-induced ulcer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of endscopic finding 4 weeks and 8 weeks after initiating rabeprazole or famotidine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 rabeprazole sodium
Interventions/Control_2 famotidine
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. Patients of 20 years or older
2. Patients taking low-dose aspirin more than 4 weeks
3. Patients who will take low-dose aspirin at least 8 weeks
4. Patients with written informed consent


Key exclusion criteria 1. Patients with allergy for rabeprazole and famotidine
2. Patients who have taken endoscopic banding
3. Patients who have taken digestive surgical procedure
4. Patients under treatment of atazanavir sulfate
5. Patients who have taken proton pomp inhibiter within 2 weeks before endoscopy
6. Patients who have taken NSAIDS or steroid
7. Patients who have malignant neoplasm or serious disease
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Watanabe
Organization Osaka City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-4-3 Asahimachi, Abeno-ku Osaka City, Osaka 545-8585, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email watanabet@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka City University Graduate 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
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
2012 Year 04 Month 02 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 Terminated
Date of protocol fixation
2012 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 04 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
2012 Year 04 Month 02 Day
Last modified on
2014 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009012

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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