Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients
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|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|
|Study Completion Date :||October 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574925
|University Hospital Zurich|
|Principal Investigator:||Werner Schwizer, MD||UniversitaetsSpital Zuerich|