The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.
This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8-week treatment period. This study will compare the efficacy of dexlansoprazole MR (60 mg QD and 90 mg QD) with that of lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease-related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,038
Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.
Time frame: 8 Weeks
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
Time frame: 8 weeks
Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
Percentage of subjects with baseline EE grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
Time frame: 8 Weeks
Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.
Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
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Unnamed facility
Alabaster, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Chula Vista, California, United States
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Fullerton, California, United States
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Garden Grove, California, United States
...and 130 more locations
Time frame: 8 Weeks
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
Time frame: 4 Weeks
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
Time frame: 4 Weeks