A Phase 3 interventional study of esomeprazole and moxifloxacin in Helicobacter Pylori Infection and Chronic Gastritis, sponsored by Technische Universität Dresden. Status unknown at 9 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-04-04.
Sponsored by Technische Universität Dresden · Phase 3, Interventional, and Treatment
Successful H. pylori eradication therapy remains a challenge in medical practice. Despite promising data for first-line, second-line and rescue treatment options based on clinical trials as well as guidelines and expert recommendations, success rates can often not be reproduced in general practice. Rescue options for patients with failed initial or second-line therapy are definitely needed. The new fluoroquinolone moxifloxacin may represent an effective and save treatment option (in combination with a PPI and amoxicillin) for rescue therapy of H- pylori positive patients.However, optimal duration of therapy (7-day course vs 14-day course) has to be determined
Successful H. pylori eradication therapy remains a challenge in medical practice. Currently, a PPI - based triple therapy containing clarithromycin, amoxicillin or nitroimidazole given for 7 days is the recommended first line treatment approach with an expected eradication success rate of approximately 80%. As second-line treatment option in case of failure, a RBC-based quadruple therapy is currently recommended curing another 80% of patients, leaving a subset of patients with persistent H. pylori infection. Resistance to fluoroquinolones is low in most countries,hence these compounds are potential candidates for second-line and rescue treatment. The new fluoroquinolone moxifloxacin launched by Bayer in 1999 for the treatment of respiratory tract infections, has a broad antibacterial spectrum comparable to levofloxacin but fewer phototoxic and central nervous system excitatory effects. The possible role of moxifloxacin in H. pylori eradication is since under clinical investigation
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 132 is close to the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
Efficacy of a combination of esomeprazole (E), moxifloxacin (M) and amoxicillin (A) for third line therapy of H. pylori infection.
Comparison of EMA 7 days versus EMA 14 days. Hypothesis: superiority of EMA 14 days 4 weeks after end of eradication therapy
Tolerability,safety, post treatment resistance, influence of host genetics (CYP status) and pathogenicity factors of H. pylori on treatment success.
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Technische Universität Dresden