Clinical trial: Evaluation of gastric acid suppression with three doses of immediate-release esomeprazole in the fixed-dose combination of PN 400 (naproxenesomeprazole magnesium) compared with naproxen 500 mg and enteric-coated esomeprazole 20 mg: A randomized, open-label, Phase i study in healthy volunteers

Alimentary Pharmacology and Therapeutics

Volumn 32, Issue 3, 2010, Pages 414-424

  Miner Jr , P ^a   Plachetka, J ^b   Orlemans, E ^b   Fort, J G ^b   Sostek, M ^c  

^a Oklahoma Foundation for Digestive Research   (United States)

^b POZEN Inc   (United States)

^c ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ESOMEPRAZOLE; ESOMEPRAZOLE MAGNESIUM PLUS NAPROXEN; GASTROINTESTINAL AGENT; NAPROXEN; PN 400; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG HALF LIFE; DRUG RELEASE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; ENTERIC COATED TABLET; EPIGASTRIC DISCOMFORT; ERYTHROCYTE COUNT; EVENING DOSAGE; FATIGUE; FEMALE; FLU LIKE SYNDROME; GASTRIC PH MONITORING; HEADACHE; HEMATOCRIT; HEMOGLOBIN BLOOD LEVEL; HUMAN; IRON DEFICIENCY; LOWER ABDOMINAL PAIN; MALE; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMACH ACID; STOMACH DISTENSION; TIME TO MAXIMUM PLASMA CONCENTRATION; UPPER ABDOMINAL PAIN; VIRAL GASTROENTERITIS;

ADOLESCENT; ADULT; ANTI-ULCER AGENTS; CLINICAL TRIALS, PHASE I AS TOPIC; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; GASTRIC ACID; HUMANS; MAGNESIUM; MALE; MIDDLE AGED; NAPROXEN; OMEPRAZOLE; YOUNG ADULT;

EID: 77954346981     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2010.04361.x     Document Type: Article

References (21)

1. Singh G. Gastrointestinal complications of prescription and over-the-counter nonsteroidal anti-inflammatory drugs: a view from the ARAMIS database. Arthritis, Rheumatism, and Aging Medical Information System. Am J Ther 2000 7:115 121.
2. Laine L. Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient. Gastroenterology 2001 120:594 606.
3. Laine L, Bombardier C, Hawkey CJ, et al. Stratifying the risk of NSAID-related upper gastrointestinal clinical events: results of a double-blind outcomes study in patients with rheumatoid arthritis. Gastroenterology 2002 123:1006 1012.
4. Lanza FL, Chan FK, Quigley EMM. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol 2009 104:728 738.
5. Hawkey CJ, Karrasch JA, Szczepanski L, et al. Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. Omeprazole versus Misoprostol for NSAID-induced Ulcer Management (OMNIUM) Study Group. N Engl J Med 1998 338:727 734.
6. Scheiman JM. Prevention of NSAID-induced ulcers. Curr Treat Options Gastroenterol 2008 11:125 134.
7. Sturkenboom MC, Burke TA, Dieleman JP, et al. Underutilization of preventive strategies in patients receiving NSAIDs. Rheumatology (Oxford) 2003 42 (Suppl. 3 23 31.
8. Abraham NS, El-Serag HB, Johnson ML, et al. National adherence to evidence-based guidelines for the prescription of nonsteroidal anti-inflammatory drugs. Gastroenterology 2005 129:1171 1178.
9. Sturkenboom MCJM, Burke TA, Tangelder MJD, et al. Adherence to proton pump inhibitors or H2-receptor antagonists during the use of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther 2003 18:1137 1147.
10. van Soest EM, Sturkenboom MCJM, Dieleman JP, et al. Adherence to gastroprotection and the risk of NSAID-related upper gastrointestinal ulcers and haemorrhage. Aliment Pharmacol Ther 2007 26:265 275.
11. Goldstein JL, Howard KB, Walton SM, et al. Impact of adherence to concomitant gastroprotective therapy on nonsteroidal-related gastroduodenal ulcer complications. Clin Gastroenterol Hepatol 2006 4:1337 1345.
12. Kearney PM, Baigent C, Godwin J, et al. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ 2006 332:1302 1308.
13. McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA 2006 296:1633 1644.
14. Singh G, Fort JG, Goldstein JL, et al. Celecoxib versus naproxen and diclofenac in osteoarthritis patients: SUCCESS-I Study. Am J Med 2006 119:255 266.
15. Miner P Jr., Katz PO, Chen Y, et al. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole: a five-way crossover study. Am J Gastroenterol 2003 98:2616 2620.
16. Scheiman JM, Yeomans ND, Talley NJ, et al. Prevention of ulcers by esomeprazole in at-risk patients using non-selective NSAIDs and COX-2 inhibitors. Am J Gastroenterol 2006 101:701 710.
17. Yeomans ND. New data on healing of nonsteroidal anti-inflammatory drug-associated ulcers and erosions. Omeprazole NSAID Steering Committee. Am J Med 1998 104:56S 61S.
18. Wilder-Smith C, Lind T, Lundin C, et al. Acid control with esomeprazole and lansoprazole: a comparative dose-response study. Scand J Gastroenterol 2007 42:157 164.
19. Goldstein JL, Sostek MB, Fort JG, et al. A single-tablet multilayer formulation of enteric-coated naproxen coupled with non-enteric-coated omeprazole is associated with a significantly reduced incidence of gastric ulcers vs. enteric-coated naproxen: a prospective, randomized, double-blind study. Gastroenterology 2008 134 (Suppl 1 A-19.
20. Goldstein JL, Hochberg M, Fort JG, et al. PN400 significantly improved upper gastrointestinal tolerability compared with enteric-coated naproxen alone in patients requiring chronic NSAID therapy: results from two prospective, randomized controlled trials. Am J Gastroenterol 2009 104:S50.
21. Hassan-Alin M, Andersson T, Bredberg E, et al. Pharmacokinetics of esomeprazole after oral and intravenous administration of single and repeated doses to healthy subjects. Eur J Clin Pharmacol 2000 56:665 670.