Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

Completed · Phase 3

Conditions studied: Esophagitis, Reflux, Esophagitis, Peptic

In brief

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.

Key facts

Study ID

NCT00251719

Run by

Takeda

People needed

2054

Starts

2005-12-01

Expected to finish

2007-01-01

Last updated by the study team

2012-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).

You may not qualify if…

• 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

Where it is running

• Study site — Hueytown, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Tallassee, Alabama, United States
• Study site — Tuscaloosa, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — North Little Rock, Arkansas, United States
• Study site — Azusa, California, United States
• Study site — Carmichael, California, United States
• Study site — Cypress, California, United States
• Study site — Fresno, California, United States
• Study site — Los Angeles, California, United States
• Study site — Modesto, California, United States
• Study site — Newport Beach, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Maria, California, United States
• Study site — Littleton, Colorado, United States
• Study site — Longmont, Colorado, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Bristol, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — Fort Myers, Florida, United States
• Study site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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