UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004837 |
|---|---|
| Receipt number | R000005762 |
| Scientific Title | Randomized control study of eradication therapy for Helicobacter pylori |
| Date of disclosure of the study information | 2011/01/07 |
| Last modified on | 2011/01/07 13:05:24 |
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Basic information
Public title
Randomized control study of eradication therapy for Helicobacter pylori
Acronym
Randomized control study of eradication therapy for Helicobacter pylori
Scientific Title
Randomized control study of eradication therapy for Helicobacter pylori
Scientific Title:Acronym
Randomized control study of eradication therapy for Helicobacter pylori
Region
| Japan |
Condition
Condition
Atrophic gastritis, Gastric ulcer, Duodenal ulcer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Find out the way to improve H. pylori eradication rate of first-line therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of eradication treatment which is evaluated by 13C-urea breath test three month after treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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
7-day quadruple therapy (lansoprazole, amoxicillin, clarithromycin, metronidazole )
Interventions/Control_2
7-day triple therapy(lansoprazole, amoxicillin, clarithromycin, metronidazole)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
H. pylori infected patients diagnosed with peptic ulcer or atrophic gastritis by endoscopic examinations.
Key exclusion criteria
(1) age less than 18 years, (2)allergy to antibiotics, (3) active peptic ulcer undergoing PPI treatment, (4) present malignancy or history of malignancy, (5) previous subtotal or total gastrectomy, (6) pregnancy or nursing, and (7) previous failed H. pylori eradication therapy.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayako Yanai |
Organization
Institute for Adult Diseases, Asahi Life Foundation
Division name
Gastroenterology
Zip code
Address
1-6-1 Marunouchi, Chiyoda-ku, Tokyo 100-0005, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Institute for Adult Diseases, Asahi Life Foundation
Division name
Gastroenterology
Zip code
Address
1-6-1 Marunouchi, Chiyoda-ku, Tokyo 100-0005, Japan
TEL
Homepage URL
Sponsor or person
Institute
Institute for Adult Diseases, Asahi Life Foundation
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2011 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2007 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | 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
| 2011 | Year | 01 | Month | 07 | Day |
Last modified on
| 2011 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005762
