Efficacy and Safety of Pregabalin/Tramadol Combination Versus Pregabalin in Acute Pain of Neuropathic Origin

Summary

Phase IIIb confirmatory study of efficacy and safety, longitudinal, multicenter, randomized, double-blind study of the combination Pregabalin/Tramadol versus Pregabalin in the management of acute pain of neuropathic origin.

Timeline

Start

2022-07-11

Primary completion

2023-04-18

Completion

2023-04-25

Publications

• Background Taylor RS. Epidemiology of refractory neuropathic pain. Pain Pract. 2006 Mar;6(1):22-6. doi: 10.1111/j.1533-2500.2006.00054.x.
• Background Torrance N, Smith BH, Bennett MI, Lee AJ. The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey. J Pain. 2006 Apr;7(4):281-9. doi: 10.1016/j.jpain.2005.11.008.
• Background Matthiesen T, Wohrmann T, Coogan TP, Uragg H. The experimental toxicology of tramadol: an overview. Toxicol Lett. 1998 Mar 16;95(1):63-71. doi: 10.1016/s0378-4274(98)00023-x.
• Background Randinitis EJ, Posvar EL, Alvey CW, Sedman AJ, Cook JA, Bockbrader HN. Pharmacokinetics of pregabalin in subjects with various degrees of renal function. J Clin Pharmacol. 2003 Mar;43(3):277-83. doi: 10.1177/0091270003251119.
• Background Ardakani YH, Rouini MR. Pharmacokinetics of tramadol and its three main metabolites in healthy male and female volunteers. Biopharm Drug Dispos. 2007 Dec;28(9):527-34. doi: 10.1002/bdd.584.
• Background de Moraes NV, Lauretti GR, Lanchote VL. Effects of type 1 and type 2 diabetes on the pharmacokinetics of tramadol enantiomers in patients with neuropathic pain phenotyped as cytochrome P450 2D6 extensive metabolizers. J Pharm Pharmacol. 2014 Sep;66(9):1222-30. doi: 10.1111/jphp.12255. Epub 2014 Apr 10.
• Background Bockbrader HN, Radulovic LL, Posvar EL, Strand JC, Alvey CW, Busch JA, Randinitis EJ, Corrigan BW, Haig GM, Boyd RA, Wesche DL. Clinical pharmacokinetics of pregabalin in healthy volunteers. J Clin Pharmacol. 2010 Aug;50(8):941-50. doi: 10.1177/0091270009352087. Epub 2010 Feb 10.
• Background Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4.
• Background Lee S, Kim Y, Lee JJS, Im G, Cho JY, Chung JY, Yoon S. A pharmacokinetic drug-drug interaction study between pregabalin and tramadol in healthy volunteers. Eur J Clin Pharmacol. 2018 Dec;74(12):1605-1613. doi: 10.1007/s00228-018-2543-0. Epub 2018 Aug 22.
• Background Vandenbossche J, Richards H, Solanki B, Van Peer A. Single- and multiple-dose pharmacokinetic studies of tramadol immediate-release tablets in children and adolescents. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):184-92. doi: 10.1002/cpdd.169. Epub 2014 Dec 22.
• Background Vandenbossche J, Van Peer A, Richards H. Single-Dose Pharmacokinetic Study of Tramadol Extended-Release Tablets in Children and Adolescents. Clin Pharmacol Drug Dev. 2016 Sep;5(5):343-53. doi: 10.1002/cpdd.266. Epub 2016 Jun 12.
• Background Dou Z, Jiang Z, Zhong J. Efficacy and safety of pregabalin in patients with neuropathic cancer pain undergoing morphine therapy. Asia Pac J Clin Oncol. 2017 Apr;13(2):e57-e64. doi: 10.1111/ajco.12311. Epub 2014 Dec 22.
• Background Harati Y, Gooch C, Swenson M, Edelman S, Greene D, Raskin P, Donofrio P, Cornblath D, Sachdeo R, Siu CO, Kamin M. Double-blind randomized trial of tramadol for the treatment of the pain of diabetic neuropathy. Neurology. 1998 Jun;50(6):1842-6. doi: 10.1212/wnl.50.6.1842.
• Background Wang SL, Wang H, Nie HY, Bu G, Shen XD, Wang H. The efficacy of pregabalin for acute pain control in herpetic neuralgia patients: A meta-analysis. Medicine (Baltimore). 2017 Dec;96(51):e9167. doi: 10.1097/MD.0000000000009167.
• Background Markman J, Resnick M, Greenberg S, Katz N, Yang R, Scavone J, Whalen E, Gregorian G, Parsons B, Knapp L. Efficacy of pregabalin in post-traumatic peripheral neuropathic pain: a randomized, double-blind, placebo-controlled phase 3 trial. J Neurol. 2018 Dec;265(12):2815-2824. doi: 10.1007/s00415-018-9063-9. Epub 2018 Sep 21.
• Background Onakpoya IJ, Thomas ET, Lee JJ, Goldacre B, Heneghan CJ. Benefits and harms of pregabalin in the management of neuropathic pain: a rapid review and meta-analysis of randomised clinical trials. BMJ Open. 2019 Jan 21;9(1):e023600. doi: 10.1136/bmjopen-2018-023600.
• Background Freynhagen R, Serpell M, Emir B, Whalen E, Parsons B, Clair A, Latymer M. A comprehensive drug safety evaluation of pregabalin in peripheral neuropathic pain. Pain Pract. 2015 Jan;15(1):47-57. doi: 10.1111/papr.12146. Epub 2013 Nov 27.
• Background Mercier F, Claret L, Prins K, Bruno R. A Model-Based Meta-analysis to Compare Efficacy and Tolerability of Tramadol and Tapentadol for the Treatment of Chronic Non-Malignant Pain. Pain Ther. 2014 Jun;3(1):31-44. doi: 10.1007/s40122-014-0023-5. Epub 2014 Feb 13.
• Background Blanco E, Galvez R, Zamorano E, Lopez V, Perez M. [Prevalence of neuropathic pain according to the NP4 test in primary care]. Semergen. 2012 May-Jun;38(4):203-10. doi: 10.1016/j.semerg.2011.10.012. Epub 2011 Dec 21. Spanish.
• Background Moon DE, Lee DI, Lee SC, Song SO, Yoon DM, Yoon MH, Kim HK, Lee YW, Kim C, Lee PB. Efficacy and tolerability of pregabalin using a flexible, optimized dose schedule in Korean patients with peripheral neuropathic pain: a 10-week, randomized, double-blind, placebo-controlled, multicenter study. Clin Ther. 2010 Dec;32(14):2370-85. doi: 10.1016/j.clinthera.2011.01.014.

Drugs

Indications