Drug Information for Amoxicillin Tablets, USP (Aurobindo Pharma Limited): CLINICAL STUDIES

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  • H. pylori  Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Randomized, double-blind clinical studies performed in the United States in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in combination with amoxicillin capsules as dual 14-day therapy, for the eradication of H. pylori. Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established:Triple Therapy Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily.Dual Therapy Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily. All treatments were for 14 days. H. pylori eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment. Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.  H. pylori Eradication Rates – Triple Therapy (amoxicillin/clarithromycin/lansoprazole)           Percent of Patients Cured [95% Confidence Interval] (Number of Patients)
    * This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, (Delta West Ltd., Bentley, Australia), histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy.Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy. (p<0.05) versus lansoprazole/amoxicillin and lansoprazole/clarithromycin dual therapy.§ (p<0.05) versus clarithromycin/amoxicillin dual therapy.
    Study Triple Therapy Triple Therapy
    Evaluable Analysis* Intent-to-Treat Analysis
    Study 1 92 [80 - 97.7] (n = 48) 86 [73.3 - 93.5] (n = 55)
    Study 2 86§ [75.7 - 93.6] (n = 66) 83§ [72 - 90.8] (n = 70)
    H. pylori Eradication Rates – Dual Therapy (amoxicillin/lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients)
    * This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy.Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy. (p<0.05) versus lansoprazole alone.§ (p<0.05) versus lansoprazole alone or amoxicillin alone.
    Study Dual Therapy Dual Therapy
    Evaluable Analysis* Intent-to-Treat Analysis
    Study 1 77 [62.5 - 87.2] (n = 51) 70 [56.8 - 81.2] (n = 60)
    Study 2 66§ [51.9 - 77.5] (n = 58) 61§ [48.5 - 72.9] (n = 67)
  • Drug Information Provided by National Library of Medicine (NLM).
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