Clinical trial: endoscopic evaluation of naproxen etemesil, a naproxen prodrug, vs. naproxen – a proof-of-concept, randomized, double-blind, active-comparator study
Version of Record online: 23 AUG 2010
© 2010 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 32, Issue 9, pages 1091–1101, November 2010
How to Cite
Goldstein, J. L., Jungwirthová, A., David, J., Spindel, E., Bouchner, L., Pešek, F., Searle, S., Škopek, J., Grim, J., Ulč, I. and Sewell, K. L. (2010), Clinical trial: endoscopic evaluation of naproxen etemesil, a naproxen prodrug, vs. naproxen – a proof-of-concept, randomized, double-blind, active-comparator study. Alimentary Pharmacology & Therapeutics, 32: 1091–1101. doi: 10.1111/j.1365-2036.2010.04442.x
- Issue online: 6 OCT 2010
- Version of Record online: 23 AUG 2010
- Publication data Submitted 28 June 2010 First decision 7 July 2010 Resubmitted 3 August 2010 Accepted 3 August 2010 EV Pub Online 23 August 2010
- 1Changing perceptions and practices regarding aspirin, nonsteroidal anti-inflammatory drugs, and cyclooxygenase-2 selective nonsteroidal anti-inflammatory drugs among US primary care providers. Aliment Pharmacol Ther 2008; 28: 1249–58., , , , .
- 3NSAID-associated deaths: the rise and fall of NSAID-associated GI mortality. Am J Gastroenterol 2005; 100: 1694–5..Direct Link:
- 4A nationwide study of mortality associated with hospital admission due to severe gastrointestinal events and those associated with nonsteroidal antiinflammatory drug use. Am J Gastroenterol 2005; 100: 1685–93., , , et al.Direct Link:
- 21NSAID injury to the gastrointestinal tract: evidence that NSAIDs interact with phospholipids to weaken the hydrophobic surface barrier and induce the formation of unstable pores in membranes. J Pharm Pharmacol 2006; 58: 1421–8., , , .
- 23Clinical trial: incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone. Aliment Pharmacol Ther 2010; 32: 401–13., , , , , .
- 24Does high-dose famotidine reduce gastric and duodenal ulcers in NSAID users? Two double-blind six-month trials of single-tablet combination ibuprofen-famotidine vs. ibuprofen alone (REDUCE-1 and 2) [abstract]. Gastroenterology 2009; 136(5 Suppl 1): A69., , .
- 25LT-NS001, a naproxen pro-drug with minimal COX inhibition while intact, results in equal plasma exposure to naproxen in volunteers aged 45–70 compared with Naprosyn®. Gut 2009; 58(Suppl II): A270., , , et al.
- 28A multicenter, randomized, double-blind, active-comparator, placebo-controlled, parallel-group comparison of the incidence of endoscopic gastric and duodenal ulcer rates with valdecoxib or naproxen in healthy subjects aged 65 to 75 years. Clin Ther 2006; 28: 340–51., , , et al.
- 32Reliability, validity, and responsiveness of severity of dyspepsia assessment (SODA) in a randomized clinical trial of a COX-2-specific inhibitor and traditional NSAID therapy. Am J Gastroenterol 2002; 97: 32–9., , , , , .Direct Link:
- 40Preliminary study of the safety and efficacy of SC-58635, a novel cyclooxygenase 2 inhibitor: efficacy and safety in two placebo-controlled trials in osteoarthritis and rheumatoid arthritis, and studies of gastrointestinal and platelet effects. Arthritis Rheum 1998; 41: 1591–602., , , et al.