Esomeprazole for relief of upper gastrointestinal symptoms associated with continuous use of NSAIDs

Inclusion Criteria

• Inclusion Criteria:
• - 18 years of age, or older.
• - Capable of completing the diary card.
• - Ability to complete the HRQL questionnaires.
• - A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid
• arthritis) that requires continuous daily NSAID treatment for at least 7 months.
• - Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of
• 7 days in any given week and can include COX-2 selective NSAIDs, multiple
• NSAIDs, and high-dose aspirin (>325 mg/day).
• - Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy
• and; Are expected to remain stable for the duration of the study.
• and; Must be administered orally for the duration of the study. If more than one
• type of NSAID treatment is used, at least one type must be given orally).
• Exclusion Criteria:
• - Current, or history of, gastric or duodenal ulcer
• - Current, or history of, esophageal, gastric or duodenal surgery.
• - History of GERD, not associated with NSAID use.
• - Pain, discomfort or burning in the upper abdomen precipitated by exercise or
• relieved by defecation.
• - Pain, discomfort or burning in the upper abdomen not associated with the use of
• NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.
• - Endoscopic Barrett’s esophagus(>3 cm) or significant dysplastic changes in the esophagus