Effect of duration of postherpetic neuralgia on efficacy analyses in a multicenter, randomized, controlled study of NGX-4010, an 8% capsaicin patch evaluated for the treatment of postherpetic neuralgia

BMC Neurology

Volumn 10, Issue , 2010, Pages

  Webster, Lynn R ^a   Tark, Marvin ^b   Rauck, Richard ^c   Tobias, Jeffrey K ^d   Vanhove, Geertrui F ^d  

^a Lifetree Clinical Research and Pain Clinic   (United States)

^b Georgia Medical Research Institute   (United States)

^c Center for Clinical Research   (United States)

^d NeurogesX Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CAPSAICIN; HYDROCODONE BITARTRATE; PARACETAMOL; AGENTS ACTING ON THE PERIPHERAL NERVOUS AND NEUROMUSCULAR SYSTEMS;

ADULT; ANALGESIA; APPLICATION SITE BURNING; APPLICATION SITE DISCOLORATION; APPLICATION SITE DRYNESS; APPLICATION SITE ERYTHEMA; APPLICATION SITE PAIN; APPLICATION SITE PAPULE; APPLICATION SITE PRURITUS; APPLICATION SITE SWELLING; APPLICATION SITE URTICARIA; APPLICATION SITE VESICLE; ARTHRITIS; ARTICLE; BACKACHE; BRONCHITIS; CHOLELITHIASIS; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE DURATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOOD POISONING; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HERPES ZOSTER; HUMAN; HYPERTENSION; INJURY; LUNG TUMOR; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NOSE CONGESTION; ORTHOSTATIC HYPERTENSION; OUTCOME ASSESSMENT; PAIN; PAIN ASSESSMENT; PNEUMOTHORAX; POST HOC ANALYSIS; POSTHERPETIC NEURALGIA; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; RIB FRACTURE; SKIN IRRITATION; TACHYCARDIA; TRANSDERMAL PATCH; UPPER RESPIRATORY TRACT INFECTION; VALVULAR HEART DISEASE; VIRAL GASTROENTERITIS; VOMITING; AGED; TIME;

AGED; CAPSAICIN; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; NEURALGIA, POSTHERPETIC; PAIN MEASUREMENT; SENSORY SYSTEM AGENTS; TIME; TRANSDERMAL PATCH;

EID: 77957671908     PISSN: None     EISSN: 14712377     Source Type: Journal    
DOI: 10.1186/1471-2377-10-92     Document Type: Article

References (27)

1. Rowbotham MC, Petersen KL. Zoster-associated pain and neural dysfunction. Pain 2001, 93:1-5. 10.1016/S0304-3959(01)00328-1, 11406332.
2. Johnson RW, Dworkin RH. Treatment of herpes zoster and postherpetic neuralgia. BMJ 2003, 326:748-750. 10.1136/bmj.326.7392.748, 1125653, 12676845.
3. Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain 2002, 18:350-354. 10.1097/00002508-200211000-00002, 12441828.
4. Watson CP. A new treatment for postherpetic neuralgia. N Engl J Med 2000, 343:1563-1565. 10.1056/NEJM200011233432110, 11087888.
5. Finnerup NB, Otto M, McQuay HJ, Jensen TS, Sindrup SH. Algorithm for neuropathic pain treatment: an evidence based proposal. Pain 2005, 118:289-305. 10.1016/j.pain.2005.08.013, 16213659.
6. Backonja M, Irving G, Argoff C. Rational Multidrug Therapy in the Treatment of Neuropathic Pain. Current Pain and Headache Reports 2006, 10:34-38. 10.1007/s11916-006-0007-1, 16499828.
7. Hall GC, Carroll D, McQuay HJ. Primary care incidence and treatment of four neuropathic pain conditions: A descriptive study, 2002-2005. BMC Fam Pract 2008, 9:26. 10.1186/1471-2296-9-26, 2413228, 18460194.
8. Baron R, Wasner G. Prevention and treatment of postherpetic neuralgia. Lancet 2006, 367:186-188. 10.1016/S0140-6736(06)68010-0, 16427472.
9. Dworkin RH, O'Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, Kalso EA, Loeser JD, Miaskowski C, Nurmikko TJ, Portenoy RK, Rice AS, Stacey BR, Treede RD, Turk DC, Wallace MS. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain 2007, 132:237-251. 10.1016/j.pain.2007.08.033, 17920770.
10. Jackson KC. Pharmacotherapy for neuropathic pain. Pain Pract 2006, 6:27-33. 10.1111/j.1533-2500.2006.00055.x, 17309706.
11. Sindrup SH, Jensen TS. Efficacy of pharmacological treatments of neuropathic pain: an update and effect related to mechanism of drug action. Pain 1999, 83:389-400. 10.1016/S0304-3959(99)00154-2, 10568846.
12. Petersen KL, Fields HL, Brennum J, Sandroni P, Rowbotham MC. Capsaicin evoked pain and allodynia in post-herpetic neuralgia. Pain 2000, 88:125-133. 10.1016/S0304-3959(00)00311-0, 11050367.
13. Bley KR. Recent developments in transient receptor potential vanilloid receptor 1 agonist-based therapies. Expert Opin Investig Drugs 2004, 13:1445-1456. 10.1517/13543784.13.11.1445, 15500392.
14. Noto C, Pappagallo M, Szallasi A. NGX-4010, a high-concentration capsaicin dermal patch for lasting relief of peripheral neuropathic pain. Curr Opin Investig Drugs 2009, 10:702-10.
15. Bernstein JE, Korman NJ, Bickers DR, Dahl MV, Millikan LE. Topical capsaicin treatment of chronic postherpetic neuralgia. J Am Acad Dermatol 1989, 21(2 Pt 1):265-270. 10.1016/S0190-9622(89)70171-7, 2768576.
16. Peikert A, Hentrich M, Ochs G. Topical 0.025% capsaicin in chronic post-herpetic neuralgia: efficacy, predictors of response and long-term course. J Neurol 1991, 238:452-456. 10.1007/BF00314653, 1779253.
17. Backonja MM, Malan TP, Vanhove GF, Tobias JK, . the C102/106 Study Group NGX-4010 A High-Concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia: A Randomized, Double-Blind, Controlled Study with an Open-Label Extension. Pain Medicine 2010, 11:600-8. 10.1111/j.1526-4637.2009.00793.x, 20113411, the C102/106 Study Group NGX-4010.
18. Backonja M, Wallace MS, Blonsky ER, Cutler BJ, Malan P, Rauck R, Tobias J, . NGX-4010 C116 Study Group NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol 2008, 7:1106-1112. 10.1016/S1474-4422(08)70228-X, 18977178, NGX-4010 C116 Study Group.
19. Irving GA, Backonja M, Dunteman E, Vanhove GF, Lu S-P, Tobias JK. A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. Pain Medicine 2010,
20. Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001, 94:149-158. 10.1016/S0304-3959(01)00349-9, 11690728.
21. Schneider LS, Clark CM, Doody R, Ferris SH, Morris JC, Raman R, Reisberg B, Schmitt FA. ADCS Prevention Instrument Project: ADCS-clinicians' global impression of change scales (ADCS-CGIC), self-rated and study partner-rated versions. Alzheimer Dis Assoc Disord 2006, 20(4 Suppl 3):S124-S138. 10.1097/01.wad.0000213878.47924.44, 17135806.
22. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 1994, 23:129-138.
23. Melzack R. The short-form McGill Pain Questionnaire. Pain 1987, 30:191-197. 10.1016/0304-3959(87)91074-8, 3670870.
24. Guidance for industry: skin irritation and sensitization testing of generic transdermal drug products. , http://www.fda.gov/ohrms/dockets/98fr/990236Gd.pdf#search=%22HillTop%20Research%2C%20Inc.%20dermal%20irritation%22
25. Kost RG, Straus SE. Postherpetic neuralgia - pathogenesis, treatment, and prevention. N Engl J Med 1996, 335:32-42. 10.1056/NEJM199607043350107, 8637540.
26. Lauria G, Morbin M, Lombardi R, Capobianco R, Camozzi F, Pareyson D, Manconi M, Geppetti P. Expression of capsaicin receptor immunoreactivity in human peripheral nervous system and in painful neuropathies. J Peripher Nerv Syst 2006, 11:262-267. 10.1111/j.1529-8027.2006.0097.x, 16930289.
27. Knotkova H, Pappagallo M, Szallasi A. Capsaicin (TRPV1 Agonist) Therapy for Pain Relief: Farewell or Revival?. Clin J Pain 2008, 24:142-154. 10.1097/AJP.0b013e318158ed9e, 18209521.