A Phase 3 interventional study of Pantoprazole + Domperidone and Pantozol® in Gastroesophageal Reflux Disease, sponsored by Eurofarma Laboratorios S.A.. Withdrawn at 8 sites in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-07-24.
Sponsored by Eurofarma Laboratorios S.A. · Phase 3, Interventional, and Treatment
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
Browse Gastroesophageal Reflux studies →Eurofarma Laboratorios S.A. is the lead sponsor of 64 studies on the registry; 7 are open to participants now.
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The combination of pantoprazole and domperidone provided for the study will be the new incremental formulation produced by Eurofarma. For this study will be used doses of capsules containing 20 mg pantoprazole, 20 mg of domperidone.
Drug: Pantoprazole + Domperidone
The Pantozol® may be presented in boxes of coated tablets of 20 mg or 40 mg. For this study will be used 20 mg tablets.
Drug: Pantozol®
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
This study is withdrawn, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Eurofarma Laboratorios S.A.