Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients
Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
Participant gender:
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