Description

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.

Resources

Name	Format	Description	Link
Guidance when Developing Therapeutic Regimens for the Eradication of Helicobacter pylori in GI diseases	HTML		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 diseases	HTML		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

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