title: Evaluation of a novel solubilized formulation of ibuprofen in the treatment of migraine headache: a randomized, double-blind, placebo-controlled, dose-ranging study.
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.
authors.affiliation: Clinical Research Department, Whitehall-Robins Healthcare, Madison, NJ 07940, USA. kellstd@ahp.com
authors.forename: D E
authors.initials: DE
authors.lastname: Kellstein
authors.forename: R B
authors.initials: RB
authors.lastname: Lipton
authors.forename: R
authors.initials: R
authors.lastname: Geetha
authors.forename: K
authors.initials: K
authors.lastname: Koronkiewicz
authors.forename: F T
authors.initials: FT
authors.lastname: Evans
authors.forename: W F
authors.initials: WF
authors.lastname: Stewart
authors.forename: K
authors.initials: K
authors.lastname: Wilkes
authors.forename: S A
authors.initials: SA
authors.lastname: Furey
authors.forename: T
authors.initials: T
authors.lastname: Subramanian
authors.forename: S A
authors.initials: SA
authors.lastname: Cooper
mesh_terms: D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D000704:Analysis of Variance; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D010919:Placebos
chemical_list: D018712:Analgesics, Non-Narcotic; D005782:Gels; D010919:Placebos; D007052:Ibuprofen