Clinical Trial: Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Observational Study to Evaluate Helicobacter Pylori Eradication at the End of Routine Triple Eradication Therapy With Duodenal Ulcer Relapses Control.
Brief Summary: The Study purpose is to evaluate Helicobacter pylori susceptibility to Clarithromycin and to estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the end of treatment and 52 weeks from the therapy start
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome: Eradication rate of H. pylori at the end routine triple eradication therapy [ Time Frame: 1 year ]
Original Primary Outcome: H. pylori susceptibility rate to Clarithromycin in strains isolated from patients with active duodenal ulcer [ Time Frame: 1 year ]
Current Secondary Outcome:
- Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage) [ Time Frame: 2 years ]
- Frequency of duodenal ulcer relapses [ Time Frame: 2 years ]Frequency of duodenal ulcer relapses based on gastroscopy data and recurrence rate of H.Pylori infection based on breath test data after 52 weeks from the start of the therapy.
Original Secondary Outcome:
- Healing rates after routine H. pylori eradication therapy at the end of treatment and 52 weeks from the start of the therapy [ Time Frame: 2 years ]
- Eradication rates of H. pylori at the end of eradication treatment and 52 weeks from the start of the therapy [ Time Frame: 2 years ]
Information By: AstraZeneca
Dates:
Date Received: September 9, 2010
Date Started: November 2010
Date Completion:
Last Updated: November 22, 2013
Last Verified: November 2013
