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OpenTrials
Completed

NCT Number: NCT01199536

Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

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

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Key information

Conditions

Duodenal Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Eradication rate of H. pylori at the end routine triple eradication therapy

    Time frame: 1 year

Secondary outcomes

  1. Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage)

    Time frame: 2 years

  2. Frequency of duodenal ulcer relapses

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 13, 2010
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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