The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. The study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. During this period, the patients will receive pantoprazole (tablet) at one dose level once daily. The following observational phase lasts up to 6 months. The study will provide further data on efficacy, safety, and tolerability of pantoprazole.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
639
Altana Pharma/Nycomed
Belo Horizonte-MG, Brazil
Altana Pharma/Nycomed
Blumenau - SC, Brazil
Altana Pharma/Nycomed
Botucatu - SP, Brazil
Altana Pharma/Nycomed
Campinas - Sao Paulo, Brazil
Altana Pharma/Nycomed
Campinas - SP, Brazil
Altana Pharma/Nycomed
time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms
further efficacy criteria
safety
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Curitiba - PR, Brazil
Altana Pharma/Nycomed
Ilha Do Fundao - Rio de Janeiro - RJ, Brazil
Altana Pharma/Nycomed
Pinheiros Sao Paulo - SP, Brazil
Altana Pharma/Nycomed
Porto Alegre - RS, Brazil
Altana Pharma/Nycomed
Porto Alegre-RS, Brazil
...and 35 more locations