Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

AstraZeneca

Status: Completed

Conditions: Duodenal Ulcer

Study type: Observational

Funder types: Industry

Identifiers

NCT01199536

NIS-GRU-NEX-2009/1

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

59 participants in 1 patient group

1

Description:

patients with Helicobacter-positive duodenal ulcer