Dexlansoprazole MR-Based Concomitant Quadruple Therapy

Study Overview
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Brief Summary
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Background: Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently because the increasing incidence of clarithromycin-resistant strains of H. pylori. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising success rate of >90 % in the presence of clarithromycin resistance. However, high dose PPI is needed with a dosage of twice daily but when a dual delayed release formulation PPI in capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production. Thus, it improves acid suppression and offer benefits over conventional single release PPI formulations. by prolonging optimal plasma concentration and create a favorable condition H. pylori eradication Aim: The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy

Detailed Description
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Background: Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently because the increasing incidence of clarithromycin-resistant strains of H. pylori. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising success rate of >90% in the presence of clarithromycin resistance. However, high dose PPI is needed with a dosage of twice daily but when a dual delayed release formulation PPI in capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production. Thus, it improves acid suppression and offer benefits over conventional single release PPI formulations. by prolonging optimal plasma concentration and create a favorable condition H. pylori eradication Aim: The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy Methods: Two hundred and two consecutive H. pylori-infected participants are randomly assigned to a 7-day Dexlansoprazole MR-based non-bismuth quadruple therapy (Dexlansoprazole MR 60 mg qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days) or a 7-day lansoprazole-based non-bismuth quadruple therapy (Lansoprazole 30 mg bid. , clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days). Participants are asked to return at the 2nd week to assess drug compliance and adverse events. Repeated endoscopy with rapid urease test, histological examination is performed at the 8th week after the end of anti- H. pylori therapy. If participants refuse follow-up endoscopy, urea breath tests are conducted to assess H. pylori status. The rates of eradication are analyzed by intention-to-treat and per-protocol analysis.

Official Title
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Anti-Helicobacter Pylori Therapy With Dexlansoprazole MR-Based Concomitant Quadruple Therapy- A Prospective Randomized Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Dexlan
* Drug: Amoxicillin
* Drug: Clarithromycin 500mg
* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: H. pylori-infected outpatients with endoscopically proven peptic ulcer diseases or gastritis. Exclusion Criteria: Previous H. pylori-eradication therapy ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks patients with allergic history to the medications used patients with previous gastric surgery the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia) pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Dexlansoprazole MR group<br>Dexlansoprazole MR 60 mg qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days | Drug: Dexlan<br>* Dexlansoprazole MR 60 mg qd for 7 days<br>* Other names: Dexlansoprazole MR;Drug: Amoxicillin<br>* Amoxicillin (Amolin) 1 g bid. for 7 days<br>* Other names: Amolin;Drug: Clarithromycin 500mg<br>* clarithromycin (Klaricid) 500 mg bid for 7 days<br>* Other names: Klaricid;Drug: Metronidazole<br>* Metronidazole (Flagyl) 500 mg bid daily for 7 days<br>* Other names: Flagyl;|
| Experimental: lansoprazole group<br>Lansoprazole 30 mg bid., clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days | Drug: Dexlan<br>* Dexlansoprazole MR 60 mg qd for 7 days<br>* Other names: Dexlansoprazole MR;Drug: Amoxicillin<br>* Amoxicillin (Amolin) 1 g bid. for 7 days<br>* Other names: Amolin;Drug: Clarithromycin 500mg<br>* clarithromycin (Klaricid) 500 mg bid for 7 days<br>* Other names: Klaricid;Drug: Metronidazole<br>* Metronidazole (Flagyl) 500 mg bid daily for 7 days<br>* Other names: Flagyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rates of H.pylori eradication | The primary outcome variables were the rates of eradication. Chi-square test with or without Yates correction for continuity and Fisher's exact test were used when appropriate to compare the major outcomes between groups. A P value less than 0.05 was considered statistically significant. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-bismuth containing quadruple therapy