Phase 3
Completed N=2,054
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Esophagitis, Reflux · Esophagitis, Peptic
Source: ClinicalTrials.gov NCT00251719 ↗
Enrolled (actual)
2,054
Serious AEs
0.5%
Results posted
Mar 2009
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.