Two replicate randomized, double-blind, placebo-controlled trials of the time to onset of pain relief in the acute treatment of migraine with a fast-disintegrating/rapid-release formulation of sumatriptan tablets

Clinical Therapeutics

Volumn 27, Issue 4, 2005, Pages 407-417

  Sheftell, Fred D ^a   Dahlöf, Carl G H ^b   Brandes, Jan Lewis ^c   Agosti, Reto ^d   Jones, Martin W ^e   Barrett, Pamela S ^f  

^a NEW ENGLAND CENTER FOR HEADACHE   (United States)

^b Gothenburg Migraine Clinic   (Sweden)

^c Nashville Neuroscience Group   (United States)

^d Headache Centre Zurich Hirslanden   (Switzerland)

^e GLAXOSMITHKLINE   (United Kingdom)

^f GLAXOSMITHKLINE   (United States)

Author keywords

Fast disintegrating rapid release formulation; Migraine; Sumatriptan

Indexed keywords

PLACEBO; SUMATRIPTAN;

ADULT; ANALGESIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG EFFICACY; DRUG FORMULATION; DRUG RELEASE; FEMALE; HUMAN; MALE; MIGRAINE; NAUSEA; PARESTHESIA; RANDOMIZED CONTROLLED TRIAL; TABLET DISINTEGRATION; TABLET DISINTEGRATION TIME;

ADULT; AREA UNDER CURVE; CHEMISTRY, PHARMACEUTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INTESTINAL ABSORPTION; MALE; MIDDLE AGED; MIGRAINE DISORDERS; PAIN; SEROTONIN AGONISTS; SUMATRIPTAN; TABLETS; TIME FACTORS;

EID: 19544379522     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2005.04.003     Document Type: Article

References (25)

1. Dahlöf C. Clinical applications of new therapeutic deliveries in migraine Neurology 61 Suppl 4 2003 531 534
2. Kaniecki R.G. Mixing sumatriptan: A prospective study of stratified care using multiple formulations Headache 41 2001 862 866
3. Gruffydd-Jones K., Hood C.A., and Price D.B. A within-patient comparison of subcutaneous and oral sumatriptan in the acute treatment of migraine in general practice Cephalalgia 17 1998 31 36
4. Dahlöf C.G., and Saiers J. Sumatriptan injection and tablets in clinical practice: Results of a survey of 707 migraineurs Headache 38 1998 756 763
5. Lipton R.B., and Stewart W.F. Acute migraine therapy: Do doctors understand what patients with migraine want from therapy? Headache 39 Suppl 2 1999 520 526
6. Davies G.M., Santanello N., and Lipton R. Determinants of patient satisfaction with migraine therapy Cephalalgia 20 2000 554 560
7. MacGregor E.A., Brandes J., and Eikermann A. Migraine prevalence and treatment patterns: The global Migraine and Zolmitriptan Evaluation survey Headache 43 2003 19 26
8. Gallagher R.M., and Kunkel R. Migraine medication attributes important for patient compliance: Concerns about side effects may delay treatment Headache 43 2003 36 43
9. Massiou H. Migraine medication attributes are important for patient compliance Drugs Today (Barc) 39 Suppl D 2003 25 29
10. Ryan R., Elkind A., and Baker C.C. Sumatriptan nasal spray for the acute treatment of migraine. Results of two clinical studies Neurology 49 1997 1225 1230
11. Peikert A., Becker W.J., and Ashford E.A. Sumatriptan nasal spray: A dose-ranging study in the acute treatment of migraine Eur J Neurol 6 1999 43 49
12. Cady R.K., Wendt J.K., and Kirchner J.R. Treatment of acute migraine with subcutaneous sumatriptan JAMA 265 1991 2831 2835
13. Mushet G.R., Cady R.K., and Baker C.C. Efficacy and tolerability of subcutaneous sumatriptan administered using the IMITREX STATdose System Clin Ther 18 1996 687 699
14. Spierings E.L., Rapoport A.M., Dodick D.W., and Charlesworth B. Acute treatment of migraine with zolmitriptan 5 mg orally disintegrating tablet CNS Drugs 18 2004 1133 1141
15. Sheftell F., Ryan R., Pitman V., and Eletriptan Steering Committee Efficacy, safety, and tolerability of oral eletriptan for treatment of acute migraine: A multicenter, double-blind, placebo-controlled study conducted in the United States Headache 43 2003 202 213
16. Walls C., Lewis A., and Bullman J. Pharmacokinetic profile of a new form of sumatriptan tablets in healthy volunteers Curr Med Res Opin 20 2004 803 809
17. Available at: Center for Drug Evaluation and Research, US Food and Drug Administration Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products General Considerations Accessed January 3, 2005
18. Available at: Committee for Proprietary Medicinal Products, European Agency for the Evaluation of Medicinal Products Note for Guidance on the Investigation o f Bioavailability and Bioequivalence Accessed January 3, 2005
19. Carpay J., Schoenen J., and Ahmad F. Efficacy and tolerability of sumatriptan tablets in a fast-disintegrating, rapid-release formulation for the acute treatment of mi graine: Results of a multicenter, randomized, placebo-controlled study Clin Ther 26 2004 214 223
20. Headache Classification Committee of the International Headache Society Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain Cephalalgia 8 Suppl 7 1988 1 96
21. Kalbfleisch J.D., and Prentice R.L. The Statistical Analysis of Failure Time Data 1980 John Wiley & Sons New York
22. Pfaffenrath V., Cunin G., Sjonell G., and Prendergast S. Efficacy and safety of sumatriptan tablets (25 mg, 50 mg, and 100 mg) in the acute treatment of migraine: Defining the optimum doses of oral sumatriptan Headache 38 1998 184 190
23. Imitrex tablets 2004 GlaxoSmithKline Research Triangle Park, NC
24. Volans G.N. Migraine and drug absorption Clin Pharmacokinet 3 1978 313 318
25. Boyle R., Behan P.O., and Sutton J.A. A correlation between severity of migraine and delayed gastric emptying measured by an epigastric impedance method Br J Clin Pharmacol 30 1990 405 409