Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients
|ClinicalTrials.gov Identifier: NCT00574925|
Recruitment Status : Completed
First Posted : December 17, 2007
Last Update Posted : December 18, 2007
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
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease (GERD)||Drug: Esomeprazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|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)|
|Study Start Date :||November 2003|
|Estimated Study Completion Date :||October 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574925
|University Hospital Zurich|
|Principal Investigator:||Werner Schwizer, MD||UniversitaetsSpital Zuerich|