Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy 10 Days in the First Line Therapy

Study Overview
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Brief Summary
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The investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days

Official Title
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Comparison of the Efficacy of Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy for 10 Days in the First Line Therapy for Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial

Conditions
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Eradication Rates of the Two Regimens

Intervention / Treatment
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* Drug: D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)
* Drug: D1-D14: (lansoprazole + clarithromycin + amoxicillin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrollment. Written informed consents will be obtained from all patients prior to enrollment. Exclusion Criteria: Patients will be excluded from the study if any one of the following criteria is present: children and teenagers aged less than 20 years, history of gastrectomy, gastric malignancy, including adenocarcinoma and lymphoma, previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole), - contraindication to treatment drugs, pregnant or lactating women, severe concurrent disease Patients who cannot give informed consent by himself or herself.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential therapy 10 days<br>Sequential therapy | Drug: D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)<br>* D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid<br>* Other names: Flagyl;|
| Active Comparator: Triple therapy 14 days<br>Triple therapy | Drug: D1-D14: (lansoprazole + clarithromycin + amoxicillin)<br>* D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid<br>* Other names: Amoxicillin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis | C13-UBT will be used to assess the existence of H. pylori | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse effects | to assess the adverse effects | during eradication therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H pylori, eradication