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A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once-daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis
This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 2054 |
| Start date | 2005-12 |
| Completion | 2007-01 |
Conditions
- Esophagitis, Reflux
- Esophagitis, Peptic
Interventions
- Dexlansoprazole MR
- Dexlansoprazole MR
- Lansoprazole
Primary outcomes
- Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. — 8 Weeks
Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. 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. - Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method — 8 Weeks
Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. 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.
Countries
United States, Australia, Bulgaria, Canada, Colombia, Czechia, Germany, India, Latvia, Lithuania, New Zealand, Peru, Poland, Russia, Slovakia, South Africa