Guidance when Developing Therapeutic Regimens for the Eradication of Helicobacter pylori in GI diseases

Guidance when Developing Therapeutic Regimens for the Eradication of Helicobacter pylori in GI diseases The purpose of this document is to suggest elements for consideration when designing clinical trials dealing with eradication of H. pylori in GI diseases and to outline elements to be reviewed in the submissions. It expands on the design of clinical trials when patients with active duodenal ulcers are included as subjects in clinical trials. For other Hp associated GI diseases, the guide provides elements to be considered in the study design. 2021-07-07 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGuidancedeveloping therapeutic regimenseradicationeradication of helicobacter pyloriGI diseases Guidance when Developing Therapeutic Regimens for the Eradication of Helicobacter pylori in GI diseasesHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/helicobacter-pylori/guidance-when-developing-therapeutic-regimens-eradication-helicobacter-pylori-diseases.html Guidance when Developing Therapeutic Regimens for the Eradication of Helicobacter pylori in GI diseasesHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/helicobacter-pylori/guide-developpement-regimes-therapeutiques-visant-eradiquer-helicobacter-pylori-maladies-gastro-intestinales.html

The purpose of this document is to suggest elements for consideration when designing clinical trials dealing with eradication of H. pylori in GI diseases and to outline elements to be reviewed in the submissions. It expands on the design of clinical trials when patients with active duodenal ulcers are included as subjects in clinical trials. For other Hp associated GI diseases, the guide provides elements to be considered in the study design.

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