Dexlansoprazole MR-Based Concomitant Quadruple Therapy
Condition: Helicobacter Pylori Infection
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Dexlan; Amoxicillin; Clarithromycin 500mg; Metronidazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dexlansoprazole MR 60 mg qd for 7 days; Amoxicillin (Amolin) 1 g bid. for 7 days; clarithromycin (Klaricid) 500 mg bid for 7 days; Metronidazole (Flagyl) 500 mg bid daily for 7 days
Other intervention name(s): Dexlansoprazole MR; Amolin; Klaricid; Flagyl
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-bismuth containing quadruple therapy