Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01199536

Enrollment

Registered

2010-09-13

Start date

2010-11-30

Completion date

2013-11-30

Last updated

2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenal Ulcer

Keywords

Helicobacter-positive duodenal ulcer

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Eradication rate of H. pylori at the end routine triple eradication therapy	1 year

Secondary

Measure	Time frame	Description
Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage)	2 years	—
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.

Countries

Russia

Outcome results