Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-11-30

Brief Summary

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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

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Conditions

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Duodenal Ulcer

Keywords

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Helicobacter-positive duodenal ulcer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

patients with Helicobacter-positive duodenal ulcer

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vladimir T. Ivashkin

Role: PRINCIPAL_INVESTIGATOR

Head of Chair of Internal Diseases Propedeutics and Gastroenterology at MMA n/a I.M. Sechenov

Locations

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Research Site

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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NIS-GRU-NEX-2009/1

Identifier Type: -

Identifier Source: org_study_id