Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

Completed

• Conditions: Duodenal Ulcer

• Registration Number: NCT01199536
• Lead Sponsor: AstraZeneca

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 treatment and 52 weeks from the therapy start

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Study Start: 2010-11
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-22
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eradication rate of H. pylori at the end routine triple eradication therapy	1 year

Secondary Outcome Measures

Name	Time	Method
Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage)	2 years
Frequency of duodenal ulcer relapses	2 years	Frequency of duodenal ulcer relapses based on gastroscopy data and recurrence rate of H.Pylori infection based on breath test data after 52 weeks from the start of the therapy.

Trial Locations

Locations (1)

Research Site; 🇷🇺 Moscow, Russian Federation