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Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01199536
Collaborator
(none)
59
Enrollment
1
Location
36
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    59 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Observational Study to Evaluate Helicobacter Pylori Eradication at the End of Routine Triple Eradication Therapy With Duodenal Ulcer Relapses Control.
    Study Start Date :
    Nov 1, 2010
    Actual Primary Completion Date :
    Nov 1, 2013
    Actual Study Completion Date :
    Nov 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    1

    patients with Helicobacter-positive duodenal ulcer

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage) [2 years]

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Moscow Russian Federation

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT01199536
    Other Study ID Numbers:
    • NIS-GRU-NEX-2009/1
    First Posted:
    Sep 13, 2010
    Last Update Posted:
    Nov 25, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by AstraZeneca
    Helicobacter-positive duodenal ulcer
    Additional relevant MeSH terms:
    Duodenal Ulcer
    Ulcer

    Study Results

    No Results Posted as of Nov 25, 2013