Modelling of pain intensity and informative dropout in a dental pain model after naproxcinod, naproxen and placebo administration

British Journal of Clinical Pharmacology

Volumn 71, Issue 6, 2011, Pages 899-906

  Björnsson, Marcus A ^a,b   Simonsson, Ulrika S H ^b  

^a ASTRAZENECA R AND D   (Sweden)

^b UPPSALA UNIVERSITY   (Sweden)

Author keywords

Dropout; Naproxcinod; Naproxen; NONMEM; Time to event

Indexed keywords

IBUPROFEN; NAPROXCINOD; NAPROXEN; PLACEBO;

ADULT; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MOLAR TOOTH; NONLINEAR SYSTEM; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TOOTH EXTRACTION; TOOTH PAIN; VISUAL ANALOG SCALE;

ADULT; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; MOLAR, THIRD; NAPROXEN; PAIN MEASUREMENT; PAIN, POSTOPERATIVE; TOOTH EXTRACTION; YOUNG ADULT;

EID: 79955795569     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2011.03924.x     Document Type: Article

References (19)

1. Hill CM, Sindet-Pederson S, Seymour RA, Hawkesford JE III, Coulthard P, Lamey P-J, Cowan CG, Wickens M, Jeppsson L, Dean ADP, Svensson O. Analgesic efficacy of the cyclooxygenase-inhibiting nitric oxide donor AZD3582 in postoperative dental pain: comparison with naproxen and rofecoxib in two randomized, double-blind, placebo-controlled studies. Clin Ther 2006; 28: 1279-95.
2. Lohmander LS, McKeith D, Svensson O, Malmenäs M, Bolin L, Kalla A, Genti G, Szechinski J, Ramos-Remos C. A randomised, placebo controlled, comparative trial of the gastrointestinal safety and efficacy of AZD3582 versus naproxen in osteoarthritis. Ann Rheum Dis 2005; 64: 449-56.
3. Schnitzer TJ, Kivitz AJ, Lipetz RS, Sanders N, Hee A. Comparison of the COX-inhibiting nitric oxide donator AZD3582 and rofecoxib in treating the signs and symptoms of osteoarthritis of the knee. Arthritis Rheum 2005; 53: 827-37.
4. Karlsson J, Pivodic A, Aguirre D, Schnitzer TJ. Efficacy, safety, and tolerability of the cyclooxygenase-inhibiting nitric oxide donator naproxcinod in treating osteoarthritis of the hip or knee. J Rheumatol 2009; 36: 1290-7.
5. Sheiner LB. A new approach to the analysis of analgesic drug trials, illustrated with bromfenac data. Clin Pharmacol Ther 1994; 56: 309-22.
6. Mandema JW, Stanski DR. Population pharmacodynamic model for ketorolac analgesia. Clin Pharmacol Ther 1996; 60: 619-35.
7. Rohatagi S, Kastrissios H, Sasahara K, Truitt K, Moberly JB, Wada R, Salazar DE. Pain relief model for a COX-2 inhibitor in patients with postoperative dental pain. Br J Clin Pharmacol 2008; 66: 60-70.
8. Hu C, Sale ME. A joint model for nonlinear longitudinal data with informative dropout. J Pharmacokinet Pharmacodyn 2003; 30: 83-103.
9. Frame B, Miller R, Hutmacher MM. Joint modeling of dizziness, drowsiness, and dropout associated with pregabalin and placebo treatment of generalized anxiety disorder. J Pharmacokinet Pharmacodyn 2009; 36: 565-84.
10. Beal SL, Sheiner LB, Boeckmann AJ, eds. NONMEM Users Guides. Ellicott City, MD: ICON Development Solutions, 19892006.
11. Zhang L, Beal SL, Sheiner LB. Simultaneous vs. sequential analysis for population PK/PD data I: best-case performance. J Pharmacokinet Pharmacodyn 2003; 30: 387-404.
12. Savic RM, Jonker DM, Kerbusch T, Karlsson MO. Implementation of a transit compartment model for describing drug absorption in pharmacokinetic studies. J Pharmacokinet Pharmacodyn 2007; 34: 711-26.
13. Runkel R, Forchielli E, Sevelius H, Chaplin M, Segre E. Nonlinear plasma level response to high doses of naproxen. Clin Pharmacol Ther 1974; 15: 261-6.
14. Jonsson EN, Karlsson MO. Xpose - an S PLUS population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed 1999; 58: 51-64.
15. Lindbom L, Pihlgren P, Jonsson EN. PsN-Toolkit - a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed 2005; 79: 241-57.
16. Wilkins JJ, Langdon G, McIlleron H, Pillai GC, Smith PJ, Simonsson US. Variability in the population pharmacokinetics of pyrazinamide in South African tuberculosis patients. Eur J Clin Pharmacol 2006; 62: 727-35.
17. Runkel R, Chaplin M, Boost G, Segre E, Forchielli E. Absorption, distribution, metabolism, and excretion of naproxen in various laboratory animals and human subjects. J Pharm Sci 1972; 61: 703-8.
18. Fagerholm U, Björnsson MA. Clinical pharmacokinetics of the cyclooxygenase inhibiting nitric oxide donator (CINOD) AZD3582. J Pharm Pharmacol 2005; 57: 1539-54.
19. Friberg LE, de Greef R, Kerbusch T, Karlsson MO. Modeling and simulation of the time course of asenapine exposure response and dropout patterns in acute schizophrenia. Clin Pharmacol Ther 2009; 86: 84-91.