Status:
COMPLETED
Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers
Lead Sponsor:
AstraZeneca
Conditions:
Duodenal Ulcer
Eligibility:
All Genders
18+ years
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 treatmen...
Eligibility Criteria
Inclusion
- Active duodenal ulcer with duodenal ulcer exacerbation confirmed by endoscopic signs of duodenal ulcer disease (acute ulcer or scar deformity of the duodenal bulb) and anamnesis data.
- Helicobacter pylori positive diagnosis at entry by 13C-Urea Breath Test (UBT)
- Prescription of the standard 7-day eradication therapy including esomeprazole 20 mg bd, amoxicillin 1000 mg bd, clarithromycin 500 mg bd
- Written informed consent provided prior the start of participation in the study.
Exclusion
- Subjects who are unwilling or unable to provide informed consent
- Current complication of duodenal ulcer disease, e.g. perforation, bleeding or pyloric stenosis
- History of esophageal/gastric/duodenal surgery except of the patients underwent perforated ulcer closure or endoscopic hemostasis more than 6 months ago
- Contraindications to Esomeprazole, Amoxicillin or Clarythromycin including known or suspected hypersensitivity or allergy
- Treatment with Amoxicillin, Clarythromycin or Bismuth containing drugs one month prior to inclusion
- Two or more previous attempts to eradicate H. Pylori
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01199536
Start Date
November 1 2010
End Date
November 1 2013
Last Update
November 25 2013
Active Locations (1)
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1
Research Site
Moscow, Russia