Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

Completed · Phase 3

Conditions studied: NSAIDs, Upper GI Symptoms

In brief

This study was a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs placebo and esomeprazole 20 mg orally qd vs placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a treatment period of 4 weeks for relief of upper GI symptoms.

Key facts

Study ID

NCT00241527

Run by

AstraZeneca

People needed

556

Starts

2000-12-01

Expected to finish

2002-09-01

Last updated by the study team

2011-01-24

Who can join

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

You may qualify if…

• Signed informed consent.
• 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.)
• Hp negative by UBT, serology or biopsy based test, at visit 1.

You may not qualify if…

• 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.

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Garden Grove, California, United States
• Research Site — Orange, California, United States
• Research Site — Bradenton, Florida, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — Hollywood, Florida, United States
• Research Site — St. Petersburg, Florida, United States
• Research Site — Tavares, Florida, United States
• Research Site — Zephyrhills, Florida, United States
• Research Site — Nampa, Idaho, United States
• Research Site — Elkhart, Indiana, United States
• Research Site — Evansville, Indiana, United States
• Research Site — Newburgh, Indiana, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Hollywood, Maryland, United States
• Research Site — Butte, Montana, United States
• Research Site — Princeton, New Jersey, United States
• Research Site — Toms River, New Jersey, United States
• Research Site — Endwell, New York, United States
• Research Site — Hewlett, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Erie, Pennsylvania, United States
• Research Site — Tallassee, Alabama, United States

Full record on ClinicalTrials.gov

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