Status:
COMPLETED
Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease (GERD)
Lead Sponsor:
AstraZeneca
Conditions:
Heartburn
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A double-blind study comparing Esomeprazole Magnesium 40 mg once daily and Lansoprazole 30 mg twice daily to control the symptoms in patients with gastroesophageal reflux disease (GERD) with continued...
Eligibility Criteria
Inclusion
- Subjects must have reported history of heartburn symptoms whilst on lansoprazole 30 mg twice daily during the 30 days prior to screening.
- Subjects must have a minimal cumulative heartburn score of at least 4 for a minimum of 14 days, where zero = none, one = mild, two = moderate, three = severe.
Exclusion
- subjects history of esophageal ulcers, esophageal strictures, esophageal neoplasms, gastric or duodenal ulcers, or any other significant gastric or esophageal pathology judged to be clinically significant by the investigator.
- Subjects with persistent heartburn symptoms while on lansoprazole 30 mg twice daily for a period of \> 6 months
- Subjects with a history of severe hepatic insufficiency (specifically, Childs-Pugh Class C liver disease) that may adversely affect the metabolism abd pharmacokinetics of esomeprazole and/or lansoprazole.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2003
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00637845
Start Date
June 1 2002
End Date
February 1 2003
Last Update
January 21 2011
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