Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease

Launched by TAKEDA · May 27, 2010

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Voluntary participation in the study with signature on Informed Consent Form (ICF) prior to specific protocol procedures
• • Patients of any race
• • On outpatient treatment
• • History of frequent symptom crises related to GERD within the last 3 months (at least a frequency of twice a week, for about four to eight weeks)
• • Diagnosis of erosive esophagitis (grade A to D, according to Los Angeles Classification)
• • In good health condition, except GERD symptoms
• • Able to follow the protocol directions and to complete daily the questionnaire ReQuest™ throughout the study
• Exclusion Criteria:
• • Gastrointestinal disorder, even when related to chlorhydropeptic disorders: Barret's esophagus, peptic ulcer, Zollinger-Ellison syndrome and pyloric stenosis
• • Previous history of surgery to reduce acid secretion, or other upper gastrointestinal tract surgeries (excepting polypectomy and cholecystectomy)
• • At initial endoscopy presenting complicated disorders due to erosive esophagitis: obstructive esophageal stenoses, Schatzki ring, esophageal diverticulum, esophageal varices, achalasia and hiatal hernia
• • Pregnant women or during nursing period
• • Proton Pump Inhibitors (PPIs) within the last 10 days prior to start of the study
• • Triple therapy based on PPIs to eradicate H. pylori within the last 28 days prior to start of the study
• • H2-blockers, sucralfate and prokinetics within the last 7 days prior to start of the study
• • Systemic glucocorticoids and/or nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors) for more than 3 consecutive days a week, within the last 28 days prior to start of study, with exception of regular intake of acetyl salicylic acid in dosages of up to 163 mg/day.