Randomized controlled trial of the combined monoaminergic and opioid investigational compound GRT9906 in painful polyneuropathy

European Journal of Pain (United Kingdom)

Volumn 16, Issue 6, 2012, Pages 849-859

  Sindrup, S H ^a   Konder, R ^b   Lehmann, R ^c   Meier, T ^d   Winkel, M ^b   Ashworth, J ^b   Baron, R ^e   Jensen, T S ^f  

^a ODENSE UNIVERSITY HOSPITAL   (Denmark)

^b GRÜNENTHAL GMBH   (Germany)

^c Berlin Buch GmbH   (Germany)

^d UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^e UNIVERSITY OF KIEL   (Germany)

^f AARHUS UNIVERSITY HOSPITAL   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

GRT 9906; MU OPIATE RECEPTOR AGONIST; TRAMADOL; UNCLASSIFIED DRUG;

ADULT; AGED; ANALGESIA; ARTICLE; CONSTIPATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUROPATHIC PAIN; PAIN ASSESSMENT; POLYNEUROPATHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SLEEP DISORDER;

ADMINISTRATION, ORAL; ADULT; AGED; ANALGESICS, OPIOID; DIABETIC NEUROPATHIES; DIMETHYLAMINES; FEMALE; HUMANS; MALE; MIDDLE AGED; NEURALGIA; PHENOLS; POLYNEUROPATHIES; TRAMADOL; TREATMENT OUTCOME;

EID: 84867719250     PISSN: 10903801     EISSN: 15322149     Source Type: Journal    
DOI: 10.1002/j.1532-2149.2011.00069.x     Document Type: Article

References (39)

1. Alvan G, Bechtel P, Iselius L, Gundert-Remy U. Hydroxylation polymorphisms of debrisoquine and mephenytoin in European populations. Eur J Clin Pharmacol 1990; 39:533-7.
2. Bech P, Rasmussen NA, Olsen LR, Nørholm V, Abildgaard W. The sensitivity and specificity of the major depression inventory, using Present State Examination as the index of diagnostic validity. J Affect Dis 2001;66:159-64.
3. Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, et al. Development and validation of the Neuropathic Pain Symptom Inventory. Pain 2004; 108:248-57.
4. Boureau F, Legallicier P, Kabir-Ahmadi M. Tramadol in postherpetic neuralgia: a randomized, double-blind, placebocontrolled trial. Pain 2003;104:323-31.
5. Chow SG, Liu JP, editors. Design and analysis of bioavailability and bioequivalence studies. New York: Marcel Decker Inc.; 1992.
6. Cook RJ, Sackett DL. The number needed to treat: a clinically useful measure of treatment effect. Br Med J 1995; 310:452-4.
7. Costigan M, Scholz J, Woolf CJ. Neuropathic pain: a maladaptive response of the nervous system to damage. Annu Rev Neurosci 2009;32:1-32.
8. Dworkin RH, O'Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, et al. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain 2007;132:237-51.
9. Enggaard TP, Poulsen L, Arendt-Nielsen L, Brøsen K, Ossig J, Sindrup SH. The analgesic effect of tramadol after intravenous injection in healthy volunteers in relation to CYP2D6. Anesth Analg 2006;102:146-50.
10. Finnerup NB, Otto M, McQuay HJ, Jensen TS, Sindrup SH. Algorithm for neuropathic pain treatment: an evidence based proposal. Pain 2005;118:289-305.
11. Finnerup NB, Sindrup SH, Jensen TS. The evidence for pharmacological treatment of neuropathic pain. Pain 2010; 150:573-81.
12. Gilron I, Bailey JM, Tu D, Holden RR, Jackson AC, Houlden RL. Nortriptyline and gabapentin, alone or in combination for neuropathic pain: a double-blind randomized controlled cross-over trial. Lancet 2009;374:1252-61.
13. Gilron I, Bailey JM, Tu D, Holden RR, Weaver DF, Houlden RL. Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med 2005;352:1324-34.
14. Goldstein DJ, Lu Y, Detke MJ, Lee TC, Iyengar S. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain 2005;115:254-63.
15. Harati Y, Gooch C, Swenson M, Edelman S, Greene D, Raskin P, et al. Double-blind randomized trial of tramadol for the treatment of diabetic neuropathy. Neurology 1998;50:1842-6.
16. Jenkins DD, Stanton B-A, Niemcryk SJ, Rose RM. A scale for the estimation of sleep problems in clinical research. J Clin Epidemiol 1988;41:313-21.
17. Jensen TS, Baron R. Translation of symptoms and signs into mechanisms in neuropathic pain. Pain 2003;102:1-8.
18. Jensen TS, Finnerup NB. Neuropathic pain treatment: a further step forward. Lancet 2009;374:1218-9.
19. Laugesen S, Enggaard TP, Pedersen RS, Sindrup SH, Brøsen K. Paroxetine, a cytochrome P450 2D6 inhibitor, diminishes the stereoselective O-demethylation and reduces the hypoalgesic effect of tramadol. Clin Pharmacol Ther 2005;77:312-23.
20. Levy RH, Thummel KE, Trager WF, Hansten PD, Eichelbaum M, editors. Metabolic drug interactions. Philadelphia: Lippencott Williams & Wilkins; 2000.
21. Olsen LR, Jensen DV, Nørholm V, Martiny K, Bech P. The internal and external validity of the Major Depression Inventory in measuring severity of depressive states. Psychol Med 2003;33:351-6.
22. Otto M, Bach FW, Jensen TS, Brøsen K, Sindrup SH. Escitalopram in painful polyneuropathy: a randomized, placebo-controlled, cross-over trial. Pain 2008;139:275-83.
23. Paar WD, Poche S, Gerloff J, Dengler HJ. Polymorphic CYP2D6 mediates O-demethylation of the opioid analgesic tramadol. Eur J Clin Pharmacol 1997;53:235-9.
24. Poulsen L, Arendt-Nielsen L, Brøsen K, Sindrup SH. The hypoalgesic effect of tramadol in relation to CYP2D6. Clin Pharmacol Ther 1996;60:636-44.
25. Raffa RB, Friderichs E, Reimann W, Shank RP, Codd EE, Vaught JL. Opioid and nonopioid components independently contribute to the mechanism of action of tramadol, an atypical opioid analgesic. J Pharmacol Exp Ther 1992;260:275-85.
26. Rahman W, Suzuki R, Webber M, Hunt SP, Dickenson SH. Depletion of endogenous spinal 5-HAT attenuates the behavioural hypersensitivity to mechanical and cooling stimuli induced by spinal nerve ligation. Pain 2006; 123:264-74.
27. Raskin J, Prickett YL, Wang F, D'Souza DN, Waninger AL, Iyengar S, et al. A double-blind, randomized trial comparing duloxetine with placebo in the management of diabetic peripheral neuropathic pain. Pain Med 2005;6:346-56.
28. Rowbotham MC, Goli V, Kunz NR, Lei D. Venlafaxine extended release in the treatment of painful diabetic polyneuropathy: a double-blind, placebo-controlled study. Pain 2004;110:697-706.
29. Sills GJ. The mechanism of action of gabapentin and pregabalin. Curr Opin Pharmacol 2006;6:108-13.
30. Sindrup SH, Andersen G, Madsen C, Smith T, Brøsen K, Jensen TS. Tramadol relieves pain and allodynia in polyneuropathy: a randomized, double-blind, controlled trial. Pain 1999;83:85-90.
31. Sindrup SH, Bach FW, Madsen C, Gram LF, Jensen TS. Venlafaxine versus imipramine in painful polyneuropathy. A randomized, controlled trial. Neurology 2003; 60:1284-9.
32. Sindrup SH, Bjerrre U, Dejgaard A, Brøsen K, Aaes-Jørgensen T, Gram LF. The selective serotonin reuptake inhibitor citalopram relieves the symptoms of diabetic neuropathy. Clin Pharmacol Ther 1992;52:547-52.
33. Sindrup SH, Gram LF, Brøsen K, Eshøj O, Mogensen EF. The selective serotonin reuptake inhibitor paroxetine is effective in the treatment of diabetic neuropathy symptoms. Pain 1990;42:135-44.
34. Sindrup SH, Otto M, Finnerup NB, Jensen TS. Antidepressants in the treatment of neuropathic pain. Basic Clin Pharmacol Toxicol 2006;96:399-409.
35. Sommer C. Is serotonin hyperalgesic or analgesic? Curr Pain Headache Rep 2006;10:101-6.
36. Stamer UM, Lehnen K, Hothker F, Bayerer B, Wolf S, Hoeft A, et al. Impact of CYP2D6 genotype on postoperative tramadol analgesia. Pain 2003;105:231-8.
37. Suzuki R, Rahman W, Rygh LJ, Webber M, Hunt SP, Dickenson AH. Spinal-supraspinal serotonergic circuits regulating neuropathic pain and its treatment with gabapentin. Pain 2005;117:292-303.
38. Wesson DR, Ling MD. The Clinical Opiate Withdrawal Scale (COWS). J Psychoactive Drugs 2003;35:253-9.
39. Woolf CJ. Dissecting out mechanisms responsible for peripheral neuropathic pain: implications for diagnosis and therapy. Life Sci 2004;74:2605-10.