Predicting therapeutic efficacy - Experimental pain in human subjects

Brain Research Reviews

Volumn 60, Issue 1, 2009, Pages 243-254

  Chizh, Boris A ^a   Priestley, Tony ^b   Rowbotham, Michael ^c   Schaffler, Klaus ^d  

^a GLAXOSMITHKLINE   (United Kingdom)

^b MERCK RESEARCH LABORATORIES   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d HPR Human Pharmacodynamic Research GmbH   (Germany)

Author keywords

Capsaicin; Clinical trial; Human experimental pain; Translational research; UV irradiation; Vertex EEG

Indexed keywords

ACETYLSALICYLIC ACID; ANALGESIC AGENT; ANTIMIGRAINE AGENT; CANNABINOID RECEPTOR AGONIST; CANNABIS; CAPSAICIN; CELECOXIB; CLONIDINE; CLONIXIN LYSINE; CODEINE; DEXKETOPROFEN; DIPYRONE; ETHENZAMIDE; ETORICOXIB; FENTANYL; GABAPENTIN; IBUPROFEN; KAPPA OPIATE RECEPTOR AGONIST; KETOROLAC; LIDOCAINE; MORPHINE; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE; PARECOXIB; PREGABALIN; ROFECOXIB; TOPIRAMATE; UNINDEXED DRUG; VALDECOXIB;

ANALGESIA; CLINICAL TRIAL; DIABETIC NEUROPATHY; DISEASE MODEL; DRUG EFFICACY; ELECTROENCEPHALOGRAM; ELECTROSTIMULATION; HIV NEUROPATHY; HUMAN; HYPERALGESIA; NEUROPATHIC PAIN; NEUROPATHY; PAIN; PAIN ASSESSMENT; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PLACEBO EFFECT; PREDICTION; PRIORITY JOURNAL; REVIEW; SAMPLE SIZE; ULTRAVIOLET IRRADIATION;

ANALGESICS; CLINICAL TRIALS AS TOPIC; DRUG DESIGN; HUMANS; MODELS, NEUROLOGICAL; NEUROPHARMACOLOGY; OUTCOME ASSESSMENT (HEALTH CARE); PAIN; PAIN MEASUREMENT; PATIENT SELECTION; PHYSICAL STIMULATION;

EID: 63449091467     PISSN: 01650173     EISSN: 18726321     Source Type: Journal    
DOI: 10.1016/j.brainresrev.2008.12.016     Document Type: Review

References (54)

1. Abrams D.I., Jay C.A., Shade S.B., Vizoso H., Reda H., Press S., Kelly M.E., Rowbotham M.C., and Petersen K.L. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology 68 (2007) 515-521
2. Ando K., Wallace M.S., Braun J., and Schulteis G. Effect of oral mexiletine on capsaicin-induced allodynia and hyperalgesia: a double-blind, placebo-controlled, crossover study. Reg. Anesth. Pain Med. 25 (2000) 468-474
3. Angst, M.S., Clark, J.D., Carvalho, B., Tingle, M., Schmelz, M., Yeomans, D.C., 2008. Cytokine profile in human skin in response to experimental inflammation, noxious stimulation, and administration of a COX-inhibitor: a microdialysis study. Pain, in press. doi:10.1016/j.pain.2008.02.028
4. Averbeck M., Beilharz S., Bauer M., Gebhardt C., Hartmann A., Hochleitner K., Kauer F., Voith U., Simon J.C., and Termeer C. In situ profiling and quantification of cytokines released during ultraviolet B-induced inflammation by combining dermal microdialysis and protein microarrays. Exp. Dermatol. 15 (2006) 447-454
5. Backonja M., Beydoun A., Edwards K.R., Schwartz S.L., Fonseca V., Hes M., LaMoreaux L., and Garofalo E. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial. JAMA 280 (1998) 1831-1836
6. Baliki M.N., Geha P.Y., and Apkarian A.V. Spontaneous pain and brain activity in neuropathic pain: functional MRI and pharmacologic functional MRI studies. Curr. Pain Headache Rep. 11 (2007) 171-177
7. Benrath J., Eschenfelder C., Zimmerman M., and Gillardon F. Calcitonin gene-related peptide, substance P and nitric oxide are involved in cutaneous inflammation following ultraviolet irradiation. Eur. J. Pharmacol. 293 (1995) 87-96
8. Bickel A., Dorfs S., Schmelz M., Forster C., Uhl W., and Handwerker H.O. Effects of antihyperalgesic drugs on experimentally induced hyperalgesia in man. Pain 76 (1998) 317-325
9. Bishop T., Hewson D.W., Yip P.K., Fahey M.S., Dawbarn D., Young A.R., and McMahon S.B. Characterisation of ultraviolet-B-induced inflammation as a model of hyperalgesia in the rat. Pain 131 (2007) 70-82
10. Black A.K., Fincham N., Greaves M.W., and Hensby C.N. Time course changes in levels of arachidonic acid and prostaglandins D2, E2, F2 alpha in human skin following ultraviolet B irradiation. Br. J. Clin. Pharmacol. 10 (1980) 453-457
11. Borsook D., Moulton E.A., Schmidt K.F., and Becerra L.R. Neuroimaging revolutionizes therapeutic approaches to chronic pain. Mol. Pain 3 (2007) 1-8
12. Byas-Smith M.G., Max M.B., Muir J., and Kingman A. Transdermal clonidine compared to placebo in painful diabetic neuropathy using a two-stage 'enriched enrollment' design. Pain 60 (1995) 267-274
13. Challapalli V., Tremont-Lukats I.W., McNicol E.D., Lau J., and Carr D.B. Systemic administration of local anesthetic agents to relieve neuropathic pain. Cochrane Database Syst. Rev. (2005) CD003345
14. Chizh B.A., Dusch M., Puthawala M., Schmelz M., Cookson L.M., Martina R., Brown J., and Koppert W. The effect of intravenous infusion of adenosine on electrically-evoked hyperalgesia in a healthy volunteer model of central sensitization. Anesth. Analg. 99 (2004) 816-822
15. Chizh B.A., Gohring M., Troster A., Quartey G.K., Schmelz M., and Koppert W. Effects of oral pregabalin and aprepitant on pain and central sensitization in the electrical hyperalgesia model in human volunteers. Br. J. Anaesth. 98 (2007) 246-254
16. Chizh B.A., O'Donnell M.B., Napolitano A., Wang J., Brooke A.C., Aylott M.C., Bullman J.N., Gray E.J., Lai R.Y., Williams P.M., and Appleby J.M. The effects of the TRPV1 antagonist SB-705498 on TRPV1 receptor-mediated activity and inflammatory hyperalgesia in humans. Pain 132 (2007) 132-141
17. Colloca L., Lopiano L., Lanotte M., and Benedetti F. Overt versus covert treatment for pain, anxiety, and Parkinson's disease. Lancet Neurol. 3 (2004) 679-684
18. Cruccu G., Anand P., Attal N., Garcia-Larrea L., Haanpaa M., Jorum E., et al. EFNS guidelines on neuropathic pain assessment. Eur. J. Neurol. 11 (2004) 153-162
19. de Hoon J., de Lepeleire I., Hickey L., Kane S.A., Murphy M.G., Palcza J., Sinclair S., Vanmolkot F., Willson K., Xiao A., and Xu Y. Inhibition of capsaicin-induced increase in dermal microvascular blood flow by the oral CGRP antagonist, MK-0974. Cephalalgia 27 (2007) #F060
20. Doods H., Arndt K., Rudolf K., and Just S. CGRP antagonists: unravelling the role of CGRP in migraine. Trends Pharmacol. Sci. 28 (2007) 580-587
21. Dworkin R.H., Thakur R., Griesing T., Sharma U., and Young J.P. Randomized clinical trials of pregabalin for neuropathic pain: methods, results, and implications. Prog. Neurotherapeutics Neuropsychopharmacol. (2007) 1-21
22. Elliott C. Guinea-Pigging (January 7, 2008), The New Yorker
23. Fedele L., Marchini M., Acaia B., Garagiola U., and Tiengo M. Dynamics and significance of placebo response in primary dysmenorrhea. Pain 36 (1989) 43-47
24. Galer B.S., Twilling L.L., Harle J., Cluff R.S., Friedman E., and Rowbotham M.C. Lack of efficacy of riluzole in the treatment of peripheral neuropathic pain conditions. Neurology 55 (2000) 971-975
25. Gottrup H., Hansen P.O., Arendt-Nielsen L., and Jensen T.S. Differential effects of systemically administered ketamine and lidocaine on dynamic and static hyperalgesia induced by intradermal capsaicin in humans. Br. J. Anaesth. 84 (2000) 155-162
26. Gunthorpe M.J., and Szallasi A. Peripheral TRPV1 receptors as targets for drug development: new molecules and mechanisms. Curr. Pharm. Des. 14 (2008) 32-41
27. Gustorff B., Hoechtl K., Sycha T., Felouzis E., Lehr S., and Kress H.G. The effects of remifentanil and gabapentin on hyperalgesia in a new extended inflammatory skin pain model in healthy volunteers. Anesth. Analg. 98 (2004) 401-407
28. Hruza L.L., and Pentland A.P. Mechanisms of UV-induced inflammation. J. Invest. Dermatol. 100 (1993) 35S-41S
29. Iannetti G.D., Zambreanu L., Wise R.G., Buchanan T.J., Huggins J.P., Smart T.S., Vennart W., and Tracey I. Pharmacological modulation of pain-related brain activity during normal and central sensitization states in humans. Proc. Natl. Acad. Sci. 102 (2005) 18195-18200
30. Katz J., Finnerup N.B., and Dworkin R.H. Clinical trial outcome in neuropathic pain: relationship to study characteristics. Neurology 70 (2008) 263-272
31. Klede M., Handwerker H.O., and Schmelz M. Central origin of secondary mechanical hyperalgesia. J. Neurophysiol. 90 (2003) 353-359
32. Kola I., and Landis J. Can the pharmaceutical industry reduce attrition rates?. Nat. Rev. Drug Discov. 3 (2004) 711-715
33. Koppert W., Ostermeier N., Sittl R., Weidner C., and Schmelz M. Low-dose lidocaine reduces secondary hyperalgesia by a central mode of action. Pain 85 (2000) 217-224
34. Koppert W., Dern S.K., Sittl R., Albrecht S., Schuttler J., and Schmelz M. A new model of electrically evoked pain and hyperalgesia in human skin: the effects of intravenous alfentanil, S(+)-ketamine, and lidocaine. Anesthesiology 95 (2001) 395-402
35. Koppert W., Wehrfritz A., Korber N., Sittl R., Albrecht S., Schuttler J., and Schmelz M. The cyclooxygenase isozyme inhibitors parecoxib and paracetamol reduce central hyperalgesia in humans. Pain 108 (2004) 148-153
36. Koppert W., Ihmsen H., Korber N., Wehrfritz A., Sittl R., Schmelz M., and Schuttler J. Different profiles of buprenorphine-induced analgesia and antihyperalgesia in a human pain model. Pain 118 (2005) 15-22
37. Laska E., and Sunshine A. Anticipation of analgesia. A placebo effect. Headache 13 (1973) 1-11
38. McQuay H.J., Derry S., Moore R.A., Poulain P., and Legout V. Enriched enrolment with randomised withdrawal (EERW): time for a new look at clinical trial design in chronic pain. Pain 135 (2008) 217-220
39. Petersen K.L., and Rowbotham M.C. A new human experimental pain model: the heat/capsaicin sensitization model. Neuroreport. 10 (1999) 1511-1516
40. Petersen K.L., Fields H.L., Brennum J., Sandroni P., and Rowbotham M.C. Capsaicin evoked pain and allodynia in post-herpetic neuralgia. Pain 88 (2000) 125-133
41. Rowbotham M.C., and Fields H.L. The relationship of pain, allodynia and thermal sensation in post-herpetic neuralgia. Brain 119 (1996) 347-354
42. Rowbotham M., Harden N., Stacey B., Bernstein P., and Magnus-Miller L. Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. J.A.M.A. 280 (1998) 1837-1842
43. Saade N.E., Nasr I.W., Massaad C.A., Safieh-Garabedian B., Jabbur S.J., and Kanaan S.A. Modulation of ultraviolet-induced hyperalgesia and cytokine upregulation by interleukins 10 and 13. Br. J. Pharmacol. 131 (2000) 1317-1324
44. Saade N.E., Farhat O., Rahal O., Safieh-Garabedian B., Le Bars D., and Jabbur S.J. Ultra violet-induced localized inflammatory hyperalgesia in awake rats and the role of sensory and sympathetic innervation of the skin. Brain Behav. Immun. 22 (2008) 245-256
45. Salvatore C.A., Hershey J.C., Corcoran H.A., Fay J.F., Johnston V.K., Moore E.L., Mosser S.D., Burgey C.S., Paone D.V., Shaw A.W., Graham S.L., Vacca J.P., Williams T.M., Koblan K.S., and Kane S.A. Pharmacological characterization of MK-0974 [N-[(3R,6S)-6-(2,3-difluorophenyl)-2-oxo-1-(2,2,2-trifluoroethyl)azepan-3-yl]-4-(2-oxo-2,3-dihydro-1H-imidazo[4,5-b]pyridin-1-yl)piperidine-1-carboxamide], a potent and orally active calcitonin gene-related peptide receptor antagonist for the treatment of migraine. J. Pharmacol. Exp. Ther. 324 (2008) 416-421
46. Schaffler K. Drug effects on laser-evoked nociceptive eeg-responses obtained from uv- and capsaicin-irritated skin of healthy humans. Keystone Symposia: "Pain Mechanisms And The Development of Analgesics" 11.-16.06.2006 (2006), Keystone Resort, Colorado USA
47. Schaffler K., Wauschkuhn C.H., and Gierend M. Analgesic potency of a new anticonvulsant drug versus acetylsalicylic acid via laser somatosensory evoked potentials. Randomised placebo-controlled double-blind (5-way) crossover study. Arzneim.-Forsch. /Drug Res. 41 4 (1991) 427-435
48. Schaffler K., Wauschkuhn C.H., Brunnauer H., and Rehn D. Evaluation of the local anaesthetic activity of dimethindene maleate by means of laser algesimetry in healthy volunteers. Arzneim.-Forsch. /Drug Res. 42 (II) Nr. 11 (1992) 1332-1335
49. Segerdahl M. Multiple dose gabapentin attenuates cutaneous pain and central sensitisation but not muscle pain in healthy volunteers. Pain 125 (2006) 158-164
50. Sycha T., Gustorff B., Lehr S., Tanew A., Eichler H.G., and Schmetterer L. A simple pain model for the evaluation of analgesic effects of NSAIDs in healthy subjects. Br. J. Clin. Pharmacol. 56 (2003) 165-172
51. Sycha T., Anzenhofer S., Lehr S., Schmetterer L., Chizh B., Eichler H.G., and Gustorff B. Rofecoxib attenuates both primary and secondary inflammatory hyperalgesia: a randomized, double blinded, placebo controlled crossover trial in the UV-B pain model. Pain 113 (2005) 316-322
52. Thienel U., Neto W., Schwabe S.K., and Vijapurkar U. Topiramate in painful diabetic polyneuropathy: findings from three double-blind placebo-controlled trials. Acta Neurol. Scand. 110 (2004) 221-231
53. Turner E.H., Matthews A.M., Linardatos E., Tell R.A., and Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N. Eng. J. Med. 358 (2008) 252-260
54. Wallace M.S., Laitin S., Licht D., and Yaksh T.L. Concentration-effect relations for intravenous lidocaine infusions in human volunteers: effects on acute sensory thresholds and capsaicin-evoked hyperpathia. Anesthesiology 86 (1997) 1262-1272