NCT00443963 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Hawkey C, Talley NJ, Yeomans ND, Jones R, Sung JJ, Långström G, Naesdal J, Scheiman JM; NASA1 SPACE1 Study Group
Improvements with esomeprazole in patients with upper gastrointestinal symptoms taking non-steroidal antiinflammatory drugs, including selective COX-2 inhibitors. Am J Gastroenterol. 2005 May;100(5):1028-36.
Koch TR, Petro A, Darrabie M, Opara EC
Effect of the H, K-ATPase inhibitor, esomeprazole magnesium, on gut total antioxidant capacity in mice. J Nutr Biochem. 2004 Sep;15(9):522-6.
Koch TR, Petro A, Darrabie M, Opara EC
Effects of esomeprazole magnesium on nonsteroidal anti-inflammatory drug gastropathy. Dig Dis Sci. 2005 Jan;50(1):86-93.
Ofman JJ, Maclean CH, Straus WL, Morton SC, Berger ML, Roth EA, Shekelle PG
Meta-analysis of dyspepsia and nonsteroidal antiinflammatory drugs. Arthritis Rheum. 2003 Aug 15;49(4):508-18. Review.
Yeomans ND, Tulassay Z, Juhász L, Rácz I, Howard JM, van Rensburg CJ, Swannell AJ, Hawkey CJ
A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. Acid Suppression Trial: Ranitidine versus Omeprazole for NSAID-associated Ulcer Treatment (ASTRONAUT) Study Group. N Engl J Med. 1998 Mar 12;338(11):719-26.

Effects of Esomeprazole Magnesium on Gastric Free Radical Production and Total Antioxidant Capacity in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs

Details for clinical trial NCT00443963

Clinical trial NCT00443963 - References