A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain

Summary

The purpose of this study is to investigate the population pharmacokinetics of acetaminophen and naproxen from a novel acetaminophen /naproxen sodium fixed combination tablet in adolescents 12 to less than (\<) 17 years of age with post-procedure orthodontic pain and to describe the effect of subject-specific covariates, including age and body weight, on inter-subject variability in acetaminophen and naproxen pharmacokinetics in adolescents 12 to \<17 years of age with post-procedure orthodontic pain.

Timeline

Start

2023-09-13

Primary completion

2024-02-12

Completion

2024-02-14

Publications

• Background World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
• Background GUZMAN F, BRAUN C, LIM RK, POTTER GD, RODGERS DW. NARCOTIC AND NON-NARCOTIC ANALGESICS WHICH BLOCK VISCERAL PAIN EVOKED BY INTRA-ARTERIAL INJECTION OF BRADYKININ AND OTHER ALGESIC AGENTS. Arch Int Pharmacodyn Ther. 1964 Jun 1;149:571-88. No abstract available.
• Background LIM RK, GUZMAN F, RODGERS DW, GOTO K, BRAUN C, DICKERSON GD, ENGLE RJ. SITE OF ACTION OF NARCOTIC AND NON-NARCOTIC ANALGESICS DETERMINED BY BLOCKING BRADYKININ-EVOKED VISCERAL PAIN. Arch Int Pharmacodyn Ther. 1964 Nov 1;152:25-58. No abstract available.
• Background Aronoff DM, Oates JA, Boutaud O. New insights into the mechanism of action of acetaminophen: Its clinical pharmacologic characteristics reflect its inhibition of the two prostaglandin H2 synthases. Clin Pharmacol Ther. 2006 Jan;79(1):9-19. doi: 10.1016/j.clpt.2005.09.009. No abstract available.
• Background Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8. doi: 10.1016/j.clpt.2005.12.307.
• Background Mallet C, Daulhac L, Bonnefont J, Ledent C, Etienne M, Chapuy E, Libert F, Eschalier A. Endocannabinoid and serotonergic systems are needed for acetaminophen-induced analgesia. Pain. 2008 Sep 30;139(1):190-200. doi: 10.1016/j.pain.2008.03.030. Epub 2008 May 15.
• Background McGilveray IJ, Mattok GL, Fooks JR, et al. Acetaminophen II: A comparison of the physiological availabilities of different commercial dosage forms. Can J Pharmaceut Sci 1971;6:38-42.
• Background Liu DJ, Collaku A, Youngberg SP. Bioavailability and pharmacokinetic profile of a newly-developed twice-a-day sustained-release paracetamol formulation. Int J Clin Pharmacol Ther. 2015 Feb;53(2):172-81. doi: 10.5414/CP202146.
• Background Paracetamol. In: Sweetman S, ed. Martindale - The Complete Drug Reference. London, UK: The Pharmaceutical Press. 37th ed. 2011:76-79.
• Background Grosser T, Smyth E, FitzGerald. Anti-Inflammatory, Antipyretic, and Analgesic Agents; Pharmacotherapy of Gout. In: Goodman LS, Brunton LL, Chabner B, Knollman BC. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 12th ed. New York, McGraw-Hill. 2011:959- 1004.
• Background McNeil Consumer & Specialty Pharmaceuticals Clinical Pharmacology Report for Protocol 02- 161: Tolerability and multiple-dose pharmacokinetics of acetaminophen (paracetamol) at and above the currently recommended dose. Fort Washington, PA. McNeil Consumer & Specialty Pharmaceuticals Company. Aug 2005.
• Background McNeil Consumer Products Company Statistical Report 7: Interim statistical analysis of the study of the bioavailability and antipyretic effectiveness of acetaminophen in children. Fort Washington, PA. McNeil Consumer Products Company. Dec 1978. [Meta-Analysis Code P00102]
• Background McNeil Consumer Products Company Statistical Report 65 for Protocol 0-220: A double-blind multiple-dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Fort Washington, PA. McNeil Consumer Products Company. Jun 1986. [Meta-Analysis Code P80220]
• Background McNeil Protocol 2-227 Data Listings. A double-blind study of the comparative antipyretic effectiveness and safety of a single 15 mg/kg, 30 mg/kg or 40 mg/kg dose of acetaminophen. Oct 1982 [Meta-Analysis Code P82227]
• Background McNeil Consumer Products Company Report for Protocol 93-308: Pharmacokinetic and pharmacodynamic modeling of acetaminophen in febrile children: Evaluation of three products. Fort Washington, PA. McNeil Consumer Products Company. 1994. [Meta-Analysis Code P93308]
• Background McNeil Consumer Products Company Data Listings for Protocol 1-224: A double-blind study of the comparative antipyretic effectiveness and safety of a single 10 mg/kg, 20 mg/kg or 30 mg/kg dose of acetaminophen. Sep 1981. [Meta-Analysis Code P81224]
• Background Ji P, Wang Y, Li Z, Doddapaneni S, Hertz S, Furness S, Sahajwalla CG. Regulatory review of acetaminophen clinical pharmacology in young pediatric patients. J Pharm Sci. 2012 Dec;101(12):4383-9. doi: 10.1002/jps.23331. Epub 2012 Oct 16.
• Background Wilson JT, Brown RD, Bocchini JA Jr, Kearns GL. Efficacy, disposition and pharmacodynamics of aspirin, acetaminophen and choline salicylate in young febrile children. Ther Drug Monit. 1982;4(2):147-80. doi: 10.1097/00007691-198206000-00003. No abstract available.
• Background Levy G. Comparative pharmacokinetics of aspirin and acetaminophen. Arch Intern Med. 1981 Feb 23;141(3 Spec No):279-81. doi: 10.1001/archinte.141.3.279.
• Background Milligan TP, Morris HC, Hammond PM, Price CP. Studies on paracetamol binding to serum proteins. Ann Clin Biochem. 1994 Sep;31 ( Pt 5):492-6. doi: 10.1177/000456329403100512.
• Background Forrest JA, Clements JA, Prescott LF. Clinical pharmacokinetics of paracetamol. Clin Pharmacokinet. 1982 Mar-Apr;7(2):93-107. doi: 10.2165/00003088-198207020-00001.
• Background Paracetamol In: Dollery C., editor. Therapeutic drugs. 2nd ed. Vol 2. Edinburgh: Churchill Livingstone. 1999
• Background Peterson RG, Rumack BH. Pharmacokinetics of acetaminophen in children. Pediatrics. 1978 Nov;62(5 Pt 2 Suppl):877-9.
• Background Davies NM, Anderson KE. Clinical pharmacokinetics of naproxen. Clin Pharmacokinet. 1997 Apr;32(4):268-93. doi: 10.2165/00003088-199732040-00002.
• Background Product Monograph for Aleve (Naproxen Sodium Tablets USP/Liquid Gels/Capsules 220 mg). Bayer Inc. Consumer Care. Revised January 8th, 2015.
• Background Todd PA, Clissold SP. Naproxen. A reappraisal of its pharmacology, and therapeutic use in rheumatic diseases and pain states. Drugs. 1990 Jul;40(1):91-137. doi: 10.2165/00003495-199040010-00006.
• Background Segre EJ. Naproxen sodium (Anaprox): pharmacology, pharmacokinetics and drug interactions. J Reprod Med. 1980 Oct;25(4 Suppl):222-5.
• Background Sevelius H, Runkel R, Segre E, Bloomfield SS. Bioavailability of naproxen sodium and its relationship to clinical analgesic effects. Br J Clin Pharmacol. 1980 Sep;10(3):259-63. doi: 10.1111/j.1365-2125.1980.tb01753.x.
• Background Setiawati S et al. Bioequivalence study with two naproxen sodium tablet formulations in healthy subjects. J Bioequival Availab 2009;1: 28-33.
• Background Inc., P., PRODUCT MONOGRAPH, PEDIAPHARM NAPROXEN SUSPENSION, naproxen, 25 mg/mL Suspension, USP, Non-Steroidal Anti-Inflammatory Drug (NSAID) 2018.
• Background Valitalo P, Kumpulainen E, Manner M, Kokki M, Lehtonen M, Hooker AC, Ranta VP, Kokki H. Plasma and cerebrospinal fluid pharmacokinetics of naproxen in children. J Clin Pharmacol. 2012 Oct;52(10):1516-26. doi: 10.1177/0091270011418658. Epub 2011 Nov 8.
• Background Altman RD. A rationale for combining acetaminophen and NSAIDs for mild-to-moderate pain. Clin Exp Rheumatol. 2004 Jan-Feb;22(1):110-7.
• Background Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
• Background Mehlisch DR, Aspley S, Daniels SE, Southerden KA, Christensen KS. A single-tablet fixed-dose combination of racemic ibuprofen/paracetamol in the management of moderate to severe postoperative dental pain in adult and adolescent patients: a multicenter, two-stage, randomized, double-blind, parallel-group, placebo-controlled, factorial study. Clin Ther. 2010 Jun;32(6):1033-49. doi: 10.1016/j.clinthera.2010.06.002.
• Background Palma-Aguirre JA, Villalpando-Hernandez J, Novoa-Heckel G, Oliva I, Carino L, Lopez-Bojorquez E, Burke-Fraga V, Namur S, Gonzalez-de la Parra M. Bioavailability of two oral-tablet and two oral-suspension formulations of naproxen sodium/paracetamol (acetaminophen): single-dose, randomized, open-label, two-period crossover comparisons in healthy Mexican adult subjects. Clin Ther. 2009 Feb;31(2):399-410. doi: 10.1016/j.clinthera.2009.02.002.
• Background Topolski F, Moro A, Correr GM, Schimim SC. Optimal management of orthodontic pain. J Pain Res. 2018 Mar 16;11:589-598. doi: 10.2147/JPR.S127945. eCollection 2018.
• Background Cheng C, Xie T, Wang J. The efficacy of analgesics in controlling orthodontic pain: a systematic review and meta-analysis. BMC Oral Health. 2020 Sep 18;20(1):259. doi: 10.1186/s12903-020-01245-w.
• Background Monk AB, Harrison JE, Worthington HV, Teague A. Pharmacological interventions for pain relief during orthodontic treatment. Cochrane Database Syst Rev. 2017 Nov 28;11(11):CD003976. doi: 10.1002/14651858.CD003976.pub2.
• Background Krishnan V. Orthodontic pain: from causes to management--a review. Eur J Orthod. 2007 Apr;29(2):170-9. doi: 10.1093/ejo/cjl081.
• Background Polat O, Karaman AI, Durmus E. Effects of preoperative ibuprofen and naproxen sodium on orthodontic pain. Angle Orthod. 2005 Sep;75(5):791-6. doi: 10.1043/0003-3219(2005)75[791:EOPIAN]2.0.CO;2.
• Background Zarif Najafi H, Oshagh M, Salehi P, Babanouri N, Torkan S. Comparison of the effects of preemptive acetaminophen, ibuprofen, and meloxicam on pain after separator placement: a randomized clinical trial. Prog Orthod. 2015;16:34. doi: 10.1186/s40510-015-0104-y. Epub 2015 Oct 14.
• Background Gritsiuk AI. [On the problem of the effect of prednisolone and salicylates on the fibrinolytic activity of the blood in patients with rheumatism]. Ter Arkh. 1967 Sep;39(9):60-1. No abstract available. Russian.
• Background Harrington JT, Isner JM, Kassirer JP. Our national obsession with potassium. Am J Med. 1982 Aug;73(2):155-9. doi: 10.1016/0002-9343(82)90171-1. No abstract available.
• Background Bernhardt MK, Southard KA, Batterson KD, Logan HL, Baker KA, Jakobsen JR. The effect of preemptive and/or postoperative ibuprofen therapy for orthodontic pain. Am J Orthod Dentofacial Orthop. 2001 Jul;120(1):20-7. doi: 10.1067/mod.2001.115616.
• Background U.S. Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER). Population Pharmacokinetics, Guidance for Industry. (February 2022). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/population-pharmacokinetics
• Background U.S. Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research (CDER). General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products. Guidance for Industry (Draft). (September 2022). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-clinical-pharmacologyconsiderations- pediatric-studies-drugs-including-biological-products
• Background Wang Y, Jadhav PR, Lala M, Gobburu JV. Clarification on precision criteria to derive sample size when designing pediatric pharmacokinetic studies. J Clin Pharmacol. 2012 Oct;52(10):1601-6. doi: 10.1177/0091270011422812. Epub 2011 Dec 12. No abstract available.

Drugs

Indications

No indication recorded.