Status:
COMPLETED
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)
Lead Sponsor:
Takeda
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks ba...
Eligibility Criteria
Inclusion
- Main
- Outpatients
- Reflux disease-related symptoms for at least 12 weeks, which need not be consecutive, in the previous 12 months or endoscopically confirmed reflux esophagitis grade A to D, according to LA-classification
- Main
Exclusion
- Regular intake of systemic glucocorticosteroids, NSAIDs including COX-2 inhibitors on \>3 consecutive days per week within the previous 28 days; exception: regular intake of acetylsalicylic acid up to a daily dose of 150 mg/day
- Intake of PPIs (proton pump inhibitor) during the last 10 days, of histamine 2-receptor antagonists or prokinetics during the last 5 days, intake of sucralfate during the last 2 days before the start of the study
- Intake of PPIs in combination with antibiotics for eradication of H. pylori during the last 28 days prior to study start
- Eradication of H. pylori during the last 28 days prior to study start
- Acute peptic ulcer and/or ulcer complications
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00163306
Start Date
May 1 2005
Last Update
May 7 2012
Active Locations (79)
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1
Altana Pharma/Nycomed
Deutschlandsberg, Austria, 8539
2
Altana Pharma/Nycomed
Feldbach, Austria, 8330
3
Altana Pharma/Nycomed
Graz, Austria, 8010
4
Altana Pharma/Nycomed
Graz, Austria, 8020