Back to resultsLong-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy
Primary Purpose
Helicobacter Infections
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
esomeprazole
tripotassium dicitrate bismuthate
metronidazole
tetracycline
moxifloxacin
amoxicillin
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Infections
Eligibility Criteria
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.
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
MEA
EBMT
Arm Description
MEA: moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.)
EBMT: 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)
Outcomes
Primary Outcome Measures
Helicobacter pylori reinfection rate
Secondary Outcome Measures
Full Information
NCT ID
NCT01792700
First Posted
February 12, 2013
Last Updated
February 14, 2013
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01792700
Brief Title
Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
648 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEA
Arm Type
Active Comparator
Arm Description
MEA: moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.)
Arm Title
EBMT
Arm Type
Active Comparator
Arm Description
EBMT: 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)
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Intervention Type
Drug
Intervention Name(s)
tripotassium dicitrate bismuthate
Intervention Type
Drug
Intervention Name(s)
metronidazole
Intervention Type
Drug
Intervention Name(s)
tetracycline
Intervention Type
Drug
Intervention Name(s)
moxifloxacin
Intervention Type
Drug
Intervention Name(s)
amoxicillin
Primary Outcome Measure Information:
Title
Helicobacter pylori reinfection rate
Time Frame
From date of randomization until the date of first documented reinfection of Helicobacter pylori, whichever came first, assessed up to 90 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24050512
Citation
Kim MS, Kim N, Kim SE, Jo HJ, Shin CM, Park YS, Lee DH. Long-term follow up Helicobacter Pylori reinfection rate after second-line treatment: bismuth-containing quadruple therapy versus moxifloxacin-based triple therapy. BMC Gastroenterol. 2013 Sep 19;13:138. doi: 10.1186/1471-230X-13-138.
Results Reference
derived
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Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy
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