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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007550
Receipt No. R000008877
Scientific Title A randomized study comparing Esomeprazole based versus rabeprazole based triple therapy for the eradication of Helicobacter pylori.
Date of disclosure of the study information 2012/03/31
Last modified on 2016/03/22

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Basic information
Public title A randomized study comparing Esomeprazole based versus rabeprazole based triple therapy for the eradication of Helicobacter pylori.
Acronym A randomized study comparing Esomeprazole based versus rabeprazole based triple therapy for the eradication of Helicobacter pylori.
Scientific Title A randomized study comparing Esomeprazole based versus rabeprazole based triple therapy for the eradication of Helicobacter pylori.
Scientific Title:Acronym A randomized study comparing Esomeprazole based versus rabeprazole based triple therapy for the eradication of Helicobacter pylori.
Region
Japan

Condition
Condition Helicobacter pylori infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine an efficacy and safety of Esomeprazole based triple therapy as the first-line treatment for H. pylori positive patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of the eradication rate of the two regimens, Esomeprazole based vs Rabeprazole based triple therapy.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Esomeprazole 20mg, AMPC 750mg, CAM 200mg, twice a day for 7days
Interventions/Control_2 Rabeprazole 10mg, AMPC 750mg, CAM 200mg, twice a day for 7days
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 Subjects who want to receive a Helicobacter pylori infection test and to take eradication treatment if its result is positive.
Patients who give a written informed consent
Key exclusion criteria Past history of allergy for the drugs used in this
study.
Past history of taking eradication therapy.
Past history of gastrectomy.
Gastric cancer patients, pregnancy or lactation .
Severe renal dysfunction ,Blood disease,
Infectious Mononucleosis
Patients who are disqualified for the study by their physicians
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadayoshi Okimoto
Organization Oita University Hospital
Division name Dpt. of Gastroenterology
Zip code
Address 1-1 Idaigaoka Hasama-machi Yufu Oita
TEL 097-586-6193
Email okimoto@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadayoshi Okimoto
Organization Oita University Hospital
Division name Dpt. of Gastroenterology
Zip code
Address 1-1 Idaigaoka Hasama-machi Yufu Oita
TEL 097-586-6193
Homepage URL
Email okimoto@oita-u.ac.jp

Sponsor
Institute Oita University Hospital
Institute
Department

Funding Source
Organization Dpt. of General Medicine Oita University
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 03 Month 31 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
2012 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 22 Day
Last modified on
2016 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008877

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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