Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

Duodenal Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199536
• Other study ID #: NIS-GRU-NEX-2009/1
• Status: Completed
• Phase: N/A
• First received: September 9, 2010
• Last updated: November 22, 2013
• Start date: November 2010
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Duodenal Ulcer
• Ulcer

Locations

Country	Name	City	State
Russian Federation	Research Site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate of H. pylori at the end routine triple eradication therapy		1 year	No
Secondary	Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage)		2 years	No
Secondary	Frequency of duodenal ulcer relapses	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.	2 years	No