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Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01199536
First received: September 9, 2010
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Duodenal Ulcer

Study Type: Observational
Study Design: 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.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Eradication rate of H. pylori at the end routine triple eradication therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Frequency of duodenal ulcer relapses [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: October 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients with Helicobacter-positive duodenal ulcer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital patients

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199536

Locations
Russian Federation
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01199536     History of Changes
Other Study ID Numbers: NIS-GRU-NEX-2009/1
Study First Received: September 9, 2010
Last Updated: February 27, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by AstraZeneca:
Helicobacter-positive duodenal ulcer

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

ClinicalTrials.gov processed this record on May 16, 2013