Phase 3
N=2,038
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Esophagitis, Reflux · Esophagitis, Peptic
Bottom Line
View on ClinicalTrials.gov: NCT00251693 ↗Enrolled (actual)
2,038
Serious AEs
0.6%
Results posted
Mar 2009
Primary outcome: Primary: Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. — 85.3; 85.8; 79.0 Percentage of subjects — p=0.004
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 (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. |
85.3; 85.8; 79.0 | 0.004 sig |
| PRIMARY Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method. |
92.3; 92.2; 86.1 | 0.060 |
| 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. |
79.7; 74.1; 65.0 | 0.002 sig |
| 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. |
88.9; 83.8; 74.5 | 0.011 sig |
| SECONDARY Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses. |
66.2; 68.8; 64.8 | 0.705 |
| SECONDARY Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method. |
77.0; 78.8; 76.5 | 0.896 |
Summary
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.
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 hemorrhage within 4 weeks of the screening endoscopy
Data sourced from ClinicalTrials.gov (NCT00251693). 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.