- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02759029
Development of Treatment Algorithm for Eradication of Helicobacter Pylori Based on Antibiotic Susceptibility Test
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 135720
- Recruiting
- Gangnam Severance Hospital
-
Contact:
- Da Hyun Jung, MD
- Phone Number: 82-2-2019-3310
- Email: leah1004@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. positive results of rapid urease test
Exclusion Criteria:
- liver cirrhosis,
- chronic kidney disease,
- bleeding tendency,
- pregnant,
- allergy to antibiotics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Susceptibility-guided group
Drugs according to antimicrobial susceptibility-guided treatment
|
clarithromycin-based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk
|
Sham Comparator: triple therapy group
Drugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk
|
clarithromycin-based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk
|
Sham Comparator: concomitant therapy group
Drugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk Metronidazole 500mg, PO, BID, 1wk
|
clarithromycin-based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
eradication rate of Helicobacter pylori
Time Frame: the H. pylori status was checked 4 weeks aft er the end of treatment using the 13 C-urea breath test.
|
the H. pylori status was checked 4 weeks aft er the end of treatment using the 13 C-urea breath test.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3-2015-0193
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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