Status:
UNKNOWN
Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection
Lead Sponsor:
Technische Universität Dresden
Conditions:
Helicobacter Pylori Infection
Chronic Gastritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 gu...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
End Date :
February 1 2008
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00455806
Start Date
January 1 2007
End Date
February 1 2008
Last Update
April 4 2007
Active Locations (9)
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1
Gastroenterologist, private praxis
Cologne, Germany, 51063
2
Med. Dept. I, Gastroenterology, University Hospital, Technical University of Dresden
Dresden, Germany
3
Gastroenterologist / private praxis
Görlitz, Germany
4
Medical Department, University Homburg/Saar
Homburg/Saar, Germany