Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199536
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : November 25, 2013
Information provided by (Responsible Party):

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
Duodenal Ulcer

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 : November 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

patients with Helicobacter-positive duodenal ulcer

Primary Outcome Measures :
  1. Eradication rate of H. pylori at the end routine triple eradication therapy [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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.

Biospecimen Retention:   Samples Without DNA
Blood samples for Hematology (whole blood) and Chemistry (serum), gasric mucosa biopsies taken during esophagogastroduodenoscopy (EGDS) in routine practice of Moscow Medical Academy n/a I.M. Sechenov, Moscow State Medical and Stomatological University, Central Clinical Hospital of Presidential Administration

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01199536

Russian Federation
Research Site
Moscow, Russian Federation
Sponsors and Collaborators
Principal Investigator: Vladimir T. Ivashkin Head of Chair of Internal Diseases Propedeutics and Gastroenterology at MMA n/a I.M. Sechenov

Responsible Party: AstraZeneca Identifier: NCT01199536     History of Changes
Other Study ID Numbers: NIS-GRU-NEX-2009/1
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by AstraZeneca:
Helicobacter-positive duodenal ulcer

Additional relevant MeSH terms:
Duodenal Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases