Efficacy of dosing and re-dosing of two oral fixed combinations of indomethacin, prochlorperazine and caffeine compared with oral sumatriptan in the acute treatment of multiple migraine attacks: A double-blind, double-dummy, randomised, parallel group, multicentre study

International Journal of Clinical Practice

Volumn 61, Issue 8, 2007, Pages 1256-1269

  Sandrini, G ^a   Cerbo, R ^b   Del Bene, E ^c   Ferrari, A ^d   Genco, S ^e   Grazioli, I ^f   Martelletti, P ^b   Nappi, G ^a,b   Pinessi, L ^g   Sarchielli, P ^h   Tamburro, P ⁱ   Uslenghi, C ^f   Zanchin, G ^j  

^a C MONDINO NATIONAL NEUROLOGICAL INSTITUTE   (Italy)

^b SAPIENZA UNIVERSITY OF ROME   (Italy)

^c UNIVERSITY OF FLORENCE   (Italy)

^d UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^e UNIVERSITY OF BARI   (Italy)

^f Solvay Pharma SpA   (Italy)

^g UNIVERSITY OF TURIN   (Italy)

^h UNIVERSITY OF PERUGIA   (Italy)

ⁱ UNIVERSITY OF CHIETI   (Italy)

^j UNIVERSITY OF PADOVA   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIMIGRAINE AGENT; CAFFEINE; INDOMETACIN; INDOPROCAF; PROCHLORPERAZINE; SUMATRIPTAN; UNCLASSIFIED DRUG;

ADULT; ANALGESIA; ARTICLE; CENTRAL NERVOUS SYSTEM DISEASE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FORMULATION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; EFFERVESCENT TABLET; ENCAPSULATION; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; MAJOR CLINICAL STUDY; MALAISE; MALE; MIGRAINE; MULTICENTER STUDY; PAIN ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STATISTICAL SIGNIFICANCE; SYNCOPE; VERTIGO;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; ANALGESICS; CAFFEINE; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; HUMANS; INDOMETHACIN; MALE; MIDDLE AGED; MIGRAINE DISORDERS; PROCHLORPERAZINE; RECURRENCE; SUMATRIPTAN; TREATMENT OUTCOME;

EID: 34447341670     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/j.1742-1241.2007.01458.x     Document Type: Article

References (31)

1. Sicuteri F, Nicolodi M. The holistic hypothesis of migraine. Ann Ital Med Int 1997 12 (Suppl. 1 1S 32S.
2. Hu XH, Tang H, Li Q, Huang X. Central mechanism of indomethacin analgesia. Eur J Pharmacol 1994 263 : 53 7.
3. Akerman S, Williamson DJ, Kaube H, Goadsby PJ. The effect of anti-migraine compounds on nitric oxide-induced dilation of dural meningeal vessels. Eur J Pharmacol 2002 452 : 223 8.
4. Tassorelli C, Joseph SA, Buzzi MG, Nappi G. The effects on the central nervous system of nitroglycerin - Putative mechanisms and mediators. Prog Neurobiol 1999 57 : 607 24.
5. Jurna I, Brune K. Central effect of the non-steroid anti-inflammatory agents, indomethacin, ibuprofen, and diclofenac, determined in C fibre-evoked activity in single neurones of the rat thalamus. Pain 1990 41 : 71 80.
6. Guieu R, Blin O, Pouget J, Serratrice G. Analgesic effect of indomethacin shown using the nociceptive flexion reflex in humans. Ann Rheum Dis 1992 51 : 391 3.
7. Ghelardini C, Galeotti N, Grazioli I, Uslenghi C. Indomethacin, alone and combined with prochlorperazine and caffeine, but not sumatriptan, abolishes peripheral and central sensitization in in vivo models of migraine. J Pain 2004 5 : 413 9.
8. Jakubowski M, Levy D, Goor-Aryeh I et al. Terminating migraine with allodynia and ongoing central sensitization using parenteral administration of COX1/COX2 inhibitors. Headache 2005 45 : 850 61.
9. Headache Classification Subcommittee of the International Headache Society. The international classification of headache disorders - 2nd edition. Cephalalgia 2004 24 (Suppl. 1 1 160.
10. Sicuteri F, Michelacci S, Anselmi B. Termination of migraine headache by a new anti-inflammatory vasoconstrictor agent. Clin Pharmacol Ther 1965 6 : 336 44.
11. Pradalier A, Vincent D. Migraine and non-steroidal anti-inflammatory agents. Pathol Biol 1992 40 : 397 405.
12. Dodick DW. Indomethacin-responsive headache syndromes. Curr Pain Headache Rep 2004 8 : 19 26.
13. Ghelardini C, Galeotti N, Uslenghi C et al. Prochlorperazine induces central antinociception mediated by the muscarinic system. Pharmacol Res 2004 50 : 351 8.
14. US Headache Consortium. Evidence-based Guidelines for Migraine Headache in the Primary Care Setting: Pharmacological Management of Acute Attacks. http://www.aan.com/ (accessed 23 May 2007)
15. Sharma S, Prasad A, Nehru R et al. Efficacy and tolerability of prochlorperazine buccal tablets in treatment of acute migraine. Headache 2002 42 : 896 902.
16. Ghelardini C, Galeotti N, Bartolini A. Caffeine induces central cholinergic analgesia. Naunyn Schmiedebergs Arch Pharmacol 1997 356 : 590 5.
17. Laska EM, Sunshine A, Mueller F et al. Caffeine as an analgesic adjuvant. JAMA 1984 251 : 1711 8.
18. Zhang WY. A benefit-risk assessment of caffeine as an analgesic adjuvant. Drug Saf 2001 24 : 1127 42.
19. Galeotti N, Ghelardini C, Grazioli I, Uslenghi C. Indomethacin, caffeine and prochlorperazine alone and combined revert hyperalgesia in ''in vivo'' models of migraine. Pharmacol Res 2002 46 : 245 50.
20. Burstein R, Collins B, Jakubowski M. Defeating migraine pain with triptans: a race against the development of cutaneous allodynia. Ann Neurol 2004 55 : 19 26.
21. Di Monda V, Nicolodi M, Aloisio A et al. Efficacy of a fixed combination of indomethacin, prochlorperazine, and caffeine versus sumatriptan in the acute treatment of multiple migraine attacks: a multicenter, randomized, crossover trial. Headache 2003 43 : 835 44.
22. Cerbo R, Centonze V, Grazioli I et al. Efficacy of a fixed combination of indomethacin, prochlorperazine, and caffeine in the treatment of episodic tension-type headache: a double-blind, randomized, nimesulide-controlled, parallel group, multicentre trial. Eur J Neurol 2005 12 : 759 67.
23. Ferrari MD, Goadsby PJ, Roon KI, Lipton RB. Triptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia 2002 22 : 633 58.
24. International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia 2000 20 : 765 86.
25. Headache Classification Committee of the International Headache Society. Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia 1988 8 (Suppl. 7 1 96.
26. Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Migraine. CPMP/EWP/788/01 Final, December 2003.
27. Stewart WF, Lipton RB, Kolodner K et al. Reliability of the migraine disability assessment score in a population-based sample of headache sufferers. Cephalalgia 1999 19 : 107 14.
28. Spierings ELH, Gomez-Mancilla B, Grosz DE et al. Oral almotriptan vs oral sumatriptan in the abortive treatment of migraine. A double-blind, randomized, parallel-group, optimum-dose comparison. Arch Neurol 2001 58 : 944 50.
29. Goldstein J, Ryan R, Jiang K et al. Crossover comparison of rizatriptan 5 mg and 10 mg versus sumatriptan 25 mg and 50 mg in migraine. Headache 1998 38 : 737 47.
30. Mandema JW, Cox E, Alderman J. Therapeutic benefit of eletriptan compared to sumatriptan for the acute relief of migraine pain - results of a model-based meta-analysis that accounts for encapsulation. Cephalalgia 2005 25 : 715 25.
31. Tfelt-Hansen P, De Vries P, Saxena PR. Triptans in migraine. A comparative review of pharmacology, pharmacokinetics and efficacy. Drugs 2000 60 : 1259 87.