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| Sponsor: | University of Zurich |
|---|---|
| Collaborator: |
AstraZeneca |
| Information provided by: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT00574925 |
Purpose
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
Secondary endpoints will be analyzed by the following parameters and their interactions:
NSAID/ASA intake (for histological results)
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease (GERD) |
Drug: Esomeprazole |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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) |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
For inclusion in the study the subject must fulfill all of the following criteria:
Table 2: Lead GERD criteria
For inclusion in the study, all of the following lead GERD criteria should hold:
Exclusion criteria:
Any of the following is regarded as a criterion for exclusion from the study:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00574925 History of Changes |
| Other Study ID Numbers: | ACH-QBE-0201 |
| Study First Received: | December 13, 2007 |
| Last Updated: | December 17, 2007 |
| Health Authority: | Switzerland: Swissmedic |
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H. pylori |
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Omeprazole |
Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |