Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

Observational Study to Evaluate Helicobacter Pylori Eradication at the End of Routine Triple Eradication Therapy With Duodenal Ulcer Relapses Control.

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

Study Overview

• Status: Completed
• Conditions: Duodenal Ulcer

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospital patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; patients with Helicobacter-positive duodenal ulcer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eradication rate of H. pylori at the end routine triple eradication therapy	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage)		2 years
Frequency of duodenal ulcer relapses	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.	2 years

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Vladimir T. Ivashkin, Head of Chair of Internal Diseases Propedeutics and Gastroenterology at MMA n/a I.M. Sechenov

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 10, 2010
• First Posted (Estimate): September 13, 2010

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 22, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Helicobacter-positive duodenal ulcer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Duodenal Ulcer
• Other Study ID Numbers: NIS-GRU-NEX-2009/1