Phase 3
N=2,054
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Esophagitis, Reflux · Esophagitis, Peptic
Bottom Line
View on ClinicalTrials.gov: NCT00251719 ↗Enrolled (actual)
2,054
Serious AEs
0.5%
Results posted
Mar 2009
Primary outcome: Primary: Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. — 86.9; 89.4; 84.6 percentage of subjects — p=0.234
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexlansoprazole MR (Drug); Lansoprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jan 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. |
86.9; 89.4; 84.6 | 0.234 |
| PRIMARY Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method |
93.1; 94.9; 91.5 | 0.167 |
| SECONDARY 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. |
77.8; 86.3; 78.9 | 0.768 |
| SECONDARY 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. |
87.6; 93.3; 87.7 | 0.727 |
| SECONDARY Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis. |
69.7; 70.6; 65.4 | 0.100 |
| SECONDARY Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method |
80.1; 80.4; 77.0 | 0.117 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).
Exclusion Criteria
- Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
- Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
- Use of antacids [except for study supplied Gelusil®]
- Need for continuous anticoagulant therapy (Blood Thinners)
- Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
- History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
- Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition
- History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer
- Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy
Data sourced from ClinicalTrials.gov (NCT00251719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.