UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010229 |
|---|---|
| Receipt number | R000009454 |
| Scientific Title | Randomized trial of PPI-amoxicillin-clarithromycin and PPI-amoxicillin-metronidazole as first-line Helicobacter pylori eradication therapy |
| Date of disclosure of the study information | 2013/03/13 |
| Last modified on | 2014/10/01 11:54:41 |
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Basic information
Public title
Randomized trial of PPI-amoxicillin-clarithromycin and PPI-amoxicillin-metronidazole as first-line Helicobacter pylori eradication therapy
Acronym
Randomized trial of clarithromycin and metronidazole as first-line Helicobacter pylori eradication therapy
Scientific Title
Randomized trial of PPI-amoxicillin-clarithromycin and PPI-amoxicillin-metronidazole as first-line Helicobacter pylori eradication therapy
Scientific Title:Acronym
Randomized trial of clarithromycin and metronidazole as first-line Helicobacter pylori eradication therapy
Region
| Japan |
Condition
Condition
H. pylori associated gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of our prospective multicenter randomized trial is to compare the efficacy and tolerability of the 7-day first-line H. pylori eradication regimen composed of PPI, clarithromycin, and amoxicillin, with those of a regimen composed of PPI, metronidazole, and amoxicillin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Eradication rate
Key secondary outcomes
Adverse effect
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
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The 7-day triple regimen composed of rabeprazole (10 mg, b.d.), clarithromycin (400 mg, b.d.), and amoxicillin (750 mg, b.d.), is administered.
Interventions/Control_2
The 7-day triple regimen composed of rabeprazole (10 mg, b.d.), metronidazole (250 mg, b.d.), and amoxicillin (750 mg, b.d.) is administered.
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
Patients have H. pylori gastritis without peptic ulcer disease and no history of antibacterial therapy for eradication.
Key exclusion criteria
(1) age <20 years; (2) presence of clinically significant underlying disease (hepatic or renal disease, diabetes mellitus); (3) history of gastric surgery; (4) allergy to any of the drugs used in the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Nishizawa |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Division of Gastroenterology,
Zip code
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Division of Gastroenterology,
Zip code
Address
TEL
03-3411-0111
Homepage URL
Sponsor or person
Institute
The National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
the National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2013 | Year | 03 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 13 | 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
| 2013 | Year | 03 | Month | 13 | Day |
Last modified on
| 2014 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009454
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
