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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01792700
Other study ID # B-0603/031-013
Secondary ID
Status Completed
Phase Phase 4
First received February 12, 2013
Last updated February 14, 2013
Start date January 2003
Est. completion date December 2010

Study information

Verified date February 2013
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority south korea:Seoul National University Bundang Hospital
Study type Interventional

Clinical Trial Summary

patients who had failed previous H. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO test, and culture). In patients who maintained continuous H. pylori negativity for the first year after eradication therapy, H. pylori status was assessed every year. For the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.


Recruitment information / eligibility

Status Completed
Enrollment 648
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 23 Years to 84 Years
Eligibility Inclusion Criteria:

- Patients were considered persistent H. pylori infection if 13C-urea breath test (UBT) or invasive H. pylori test (Giemsa histology, CLO test, culture) were positive despite PPI-based triple therapy.

Exclusion Criteria:

- Patients were excluded from the study if they had a history of renal or hepatic impairment, previous gastric surgery, pregnancy or lactation, therapy with steroids or non-steroidal anti-inflammatory drugs, or therapy with a proton pump inhibitor (PPI) or antibiotics within four weeks of entry.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
esomeprazole

tripotassium dicitrate bismuthate

metronidazole

tetracycline

moxifloxacin

amoxicillin


Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Helicobacter pylori reinfection rate From date of randomization until the date of first documented reinfection of Helicobacter pylori, whichever came first, assessed up to 90 months Yes
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