Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

NCT01199536 | Completed

• 1 other identifier: NIS-GRU-NEX-2009/1
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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

Conditions

Duodenal Ulcer

Keywords

Helicobacter-positive duodenal ulcer

Outcome Measures

Primary Outcomes (1)

• Eradication rate of H. pylori at the end routine triple eradication therapy

  1 year

Secondary Outcomes (2)

• Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage)

  2 years

• Frequency of duodenal ulcer relapses

  2 years

Study Arms (1)

1

patients with Helicobacter-positive duodenal ulcer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital patients

You may qualify if:

• 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.

You may not qualify if:

• 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
• Two or more previous attempts to eradicate H. Pylori

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Moscow, Russia

Location

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

MeSH Terms

Conditions

Duodenal Ulcer

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Vladimir T. Ivashkin

  Head of Chair of Internal Diseases Propedeutics and Gastroenterology at MMA n/a I.M. Sechenov

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

RU (1)