An interventional study of Dexlan and Amoxicillin in Helicobacter Pylori Infection, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-14.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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
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.
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H. pylori-infected outpatients with endoscopically proven peptic ulcer diseases or gastritis.
Exclusion Criteria:
Dexlansoprazole MR 60 mg qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days
Drug: Dexlan · Drug: Amoxicillin · Drug: Clarithromycin 500mg · Drug: Metronidazole
Lansoprazole 30 mg bid., clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days
Drug: Dexlan · Drug: Amoxicillin · Drug: Clarithromycin 500mg · Drug: Metronidazole
Dexlansoprazole MR 60 mg qd for 7 days
Also known as: Dexlansoprazole MR
Amoxicillin (Amolin) 1 g bid. for 7 days
Also known as: Amolin
clarithromycin (Klaricid) 500 mg bid for 7 days
Also known as: Klaricid
Metronidazole (Flagyl) 500 mg bid daily for 7 days
Also known as: Flagyl
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.
Time frame: 8 weeks
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital