Evaluation of a novel solubilized formulation of ibuprofen in the treatment of migraine headache: A randomized, double-blind, placebo-controlled, dose-ranging study

D. E. Kellstein, R. B. Lipton, R. Geetha, K. Koronkiewicz, F. T. Evans, W. F. Stewart, K. Wilkes, S. A. Furey, T. Subramanian, S. A. Cooper

Research output: Contribution to journalArticle

79 Scopus citations

Abstract

A total of 729 migraine sufferers with moderate to severe baseline pain evaluated a single 200, 400 or 600 mg dose of a new liquigel formulation of ibuprofen over 8 h. Ibuprofen liquigels were significantly superior to placebo for cumulative headache response (pain reduced to mild or none) from 0.5 (600 mg) or 1 h (200 and 400 mg) to 8 h. At 2 h, respective headache response rates for ibuprofen 200, 400 and 600 mg and placebo were 64%, 72%, 72% and 50%. All three doses were also significantly superior to placebo for 2-h pain-free (25%, 28%, 29% and 13%, respectively) and for proportions with mild or no limitation of activity (2-8 h). Ibuprofen liquigels were generally superior to placebo for reducing photophobia, phonophobia, or nausea (1-4 h) and for global evaluation. All doses were well tolerated. These data demonstrate that ibuprofen liquigels relieve the pain, ancillary symptoms, and limitation of activity, of migraine.

Original languageEnglish (US)
Pages (from-to)233-243
Number of pages11
JournalCephalalgia
Volume20
Issue number4
DOIs
StatePublished - Dec 1 2000

Keywords

  • Ibuprofen
  • Liquigel
  • Migraine
  • NSAID
  • Nonprescription

ASJC Scopus subject areas

  • Clinical Neurology

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    Kellstein, D. E., Lipton, R. B., Geetha, R., Koronkiewicz, K., Evans, F. T., Stewart, W. F., Wilkes, K., Furey, S. A., Subramanian, T., & Cooper, S. A. (2000). Evaluation of a novel solubilized formulation of ibuprofen in the treatment of migraine headache: A randomized, double-blind, placebo-controlled, dose-ranging study. Cephalalgia, 20(4), 233-243. https://doi.org/10.1046/j.1468-2982.2000.00055.x