This superiority phase III study to compare the combination of Pantoprazole and Domperidone with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The hypothesis is that combination of the two medication at the unique capsule is better to the patients because decrease the quantity of times the patients need to take medicines during the day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Goiania
Goiânia, Goiás, Brazil
Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Curitiba
Curitiba, Paraná, Brazil
Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
Evaluate the efficacy of pantoprazole + domperidone Eurofarma at the treatment of gastroesophageal reflux disease in relation to the reference drug during 56 days using the score of symptoms
The primary objective of the study is to evaluate the efficacy of combining incremental pantoprazole and domperidone Eurofarma the treatment of gastroesophageal reflux disease in relation to the reference drug. The primary endpoint is the score of symptoms (heartburn and regurgitation) including the severity and frequency after treatment
Time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
Quality of life during the study treatment
Time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
Endoscopic cure rate for patients with erosive gastroesophageal reflux disease
Time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
Frequency of adverse events observed
Time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
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Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Campinas
Campinas, São Paulo, Brazil
Jaú
Jaú, São Paulo, Brazil
São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil