The aim of this trial is to evaluate the complete remission of erosive gastroesophageal reflux disease with pantoprazole magnesium 40 mg once daily versus esomeprazole 40 mg once daily during four-week treatment with an extension treatment for non-responding patients. The study includes a baseline period up to 14 days and a treatment period of either 4 weeks (28 -2 + 5 days), or 8 weeks depending on the cure of esophagitis due to gastroesophageal reflux. The study will provide further data on safety and tolerability of pantoprazole magnesium.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
713
1 capsule daily, 40 mg, orally, 30 minutes before breakfast
1 capsule daily, 40 mg, orally, 30 minutes before breakfast
Investigational site
Belo Horizonte/MG, Brazil
Investigational site
Curitiba/PR, Brazil
Investigational site
Goiânia/GO, Brazil
Investigational site
Porto Alegre/RS, Brazil
Comparatively evaluation of the clinical efficacy of pantoprazole magnesium and esomeprazole in the treatment of patients with erosive gastroesophageal reflux disease (GERD), considering the proportion of patients in complete remission.
A patient is considered at complete remission if he/she achieved symptoms relief and confirmed endoscopic healing at treatment end. A patient achieves symptoms relief if Reflux Questionnaire-GI score ((ReQuest™) stays below 1,73 for at least the three last consecutive treatment days, that can occur at visit V2 or visit V3 for those that did not achieve complete remission at V2 and repeated the treatment for 4 weeks more.
Time frame: After 4 treatment weeks
Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured
Time frame: After 4 and 8 treatment weeks
Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief
Treatments comparative evaluation for endoscopic healing rate
Time frame: After 4 and 8 treatment weeks
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Investigational site
Ribeirão Preto/SP, Brazil
Investigational site
Rio de Janeiro/RJ, Brazil
Investigational site
Salvador/BA, Brazil
Investigational site
Santo André/SP, Brazil
Investigational site
São Paulo/SP, Brazil