Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection

• Status: Unknown status
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Amoxicillin; Esomeprazole; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• male/female, age >/=18 years

• Helicobacter pylori infection proven by histology and culture

• indication for eradication therapy according to the Maastricht-III

• at least one failed prior eradication attempt

• pretherapeutic resistance testing (culture)

• written informed consent

Exclusion Criteria:

• in vitro resistance to moxifloxacin or amoxicillin

• current complicated peptic ulcer disease

• daily intake of NSAIDs

• co-medication with drugs known to interact with the study medication

• history of gastric surgery/vagotomy

• medical treatment for depression, known suicide attempt

• severe cardiological diseases such as bradyarrythmia, QT changes

• malignant disease

• gravidity, nursing

• women with child bearing potential must perform contraceptive measures