Status:
COMPLETED
Sequential Therapy Versus Quadruple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection
Lead Sponsor:
Soroka University Medical Center
Conditions:
Optimization of Second Line Treatment Protocol for H Pylori Eradication
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI + amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and tinidazole ) versus qu...
Detailed Description
a total of 101 patients were randomized to 2 groups : 50 in sequential group and 51 patients in quadruple group . mean age was 43 in both groups. In sequential therapy group 42 patients(84%) completed...
Eligibility Criteria
Inclusion
- signed informed consent
- age at least 18 years
- persisting H.pylori infection after at least one course of first-line standard triple therapy (Amoxycillin, Clarithromycin or Metronidazole based)
Exclusion
- history of gastrectomy
- gastric malignancy, including adenocarcinoma and lymphoma
- previous allergic reaction to antibiotics (amoxicillin, clarithromycin, metronidazole, tetracycline) and proton pump inhibitors
- Active upper gastrointestinal bleeding within the previous 1 week
- contraindications to the treatment drugs
- Pregnant or lactating women
- Severe concurrent disease or malignancy
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01481844
Start Date
November 1 2011
End Date
December 1 2014
Last Update
July 8 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Soroca UMC
Beersheba, Israel