|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
26 April 2013 |
|
Main ID: |
JPRN-UMIN000003074 |
|
Date of registration:
|
21/01/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Randomized control trial of secondary eradication therapies of Helicobacter pylori
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
2009/01/01 |
|
Target sample size:
|
180 |
|
Recruitment status: |
Open public recruiting |
|
URL:
|
http://www.umin.ac.jp/ctr/index.htm |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
Japan |
|
Telephone:
|
shinmaeda2-gi@umin.ac.jp |
|
Email:
|
shinmaeda2-gi@umin.ac.jp |
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
Japan |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The University of Tokyo Hospital Department of Gastroenterology |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Patients who fills everything the following
1)Patients with gastric or duodenal ulcer
2)Patients of primary eradication failure
3)Patients infected by Helicobacter pylori, confirmed by bacterial culture test or rapid urease test or urea breath test
4)Patients of 20 years or more
5)Patients who gives written informed consent
Exclusion criteria: 1)Pregnant females
2)Lacting woman
3)Patients who has past history of allergy for the drugs used in this study
4)Patients who has coexisting severe disease
5)Patient whom examination doctor judged improper as testee
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Gastroduodenal ulcer infected by Helicobacter pylori
|
|
Intervention(s)
|
rabeprazole 10mg bid, amoxicillin 750mg bid and metronidazole 250mg bid
lansorazole 10mg bid, amoxicillin 750mg bid and metronidazole 250mg bid
omeprazole 10mg bid, amoxicillin 750mg bid and metronidazole 250mg bid
|
|
Primary Outcome(s)
|
|
Assessment of the Helicobacter pylori eradication on the bassis of the urea breath test result
|
|
Source(s) of Monetary Support
|
|
None
|
|