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Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients

NCT00444275 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3029

Last updated 2012-12-11

Study results available
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Summary

To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.

Conditions

  • GERD

Interventions

DRUG

esomeprazole (Nexium®)

This randomized study was conducted on parallel groups and included two phases: * One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision * One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

DRUG

Xolaam®

This randomized study was conducted on parallel groups and included two phases: * One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision * One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca France Medical Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00444275 on ClinicalTrials.gov