Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients

NCT00574925 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2007-12-18

No results posted yet for this study

Summary

The primary objective of this study is to investigate whether eradication treatment of Helicobacter pylori followed by therapy with esomeprazole for a total of 8 weeks extends the time to relapse in patients with gastroesophageal reflux disease (GERD).

A relapse is defined by two consecutive symptom scores of the Eraflux questionnaire within 14 days that are equal or above the critical value of 25.

The secondary objectives are

1. To compare the time to relapse in the two H. pylori positive study groups with the H. pylori negative control group
2. To compare the pattern of inflammation and atrophy in the two H. pylori positive treatment groups with the naturally H. pylori negative control group at relapse.
3. All the above objectives analyzed for the efficacy subset that is the per-protocol patients broken down by effective H. pylori-eradication.

Secondary endpoints will be analyzed by the following parameters and their interactions:

1. Treatment : Eradicated, Non-eradicated, Hp-negative control
2. Esophagitis at study start: grades 0, A/B and C/D
3. Gender
4. Alcohol intake
5. NSAID/ASA intake (for histological results)

* Trial with medicinal product

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

DRUG: Esomeprazole

Sponsors & Collaborators

AstraZeneca
collaborator INDUSTRY
University of Zurich
lead OTHER

Principal Investigators

Werner Schwizer, MD · UniversitaetsSpital Zuerich

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: DOUBLE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Max Age: 70 Years
Sex: ALL
Healthy Volunteers: Yes

Timeline & Regulatory

Start: 2003-11-30
Completion: 2007-10-31

Countries

Switzerland

Study Locations

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Entities

Companies

AstraZeneca