Status:
COMPLETED
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Lead Sponsor:
Takeda
Conditions:
Esophagitis, Reflux
Esophagitis, Peptic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 subj...
Detailed Description
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 and 90 mg) ...
Eligibility Criteria
Inclusion
- Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
2054 Patients enrolled
Trial Details
Trial ID
NCT00251719
Start Date
December 1 2005
End Date
January 1 2007
Last Update
February 3 2012
Active Locations (144)
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1
Anniston, Alabama, United States
2
Hueytown, Alabama, United States
3
Huntsville, Alabama, United States
4
Tallassee, Alabama, United States