Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients
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
- To compare the time to relapse in the two H. pylori positive study groups with the H. pylori negative control group
- 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.
- 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:
- Treatment : Eradicated, Non-eradicated, Hp-negative control
- Esophagitis at study start: grades 0, A/B and C/D
- Alcohol intake
NSAID/ASA intake (for histological results)
- Trial with medicinal product
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients With Gastroesophageal Reflux Disease (GERD)|