UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007550 |
|---|---|
| Receipt number | 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 20:31:05 |
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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
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
okimoto@oita-u.ac.jp
Sponsor or person
Institute
Oita University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008877
