Evaluation of a novel solubilized formulation of ibuprofen in the treatment of migraine headache: a randomized, double-blind, placebo-controlled, dose-ranging study.
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.
Kellstein
D E
DE
Clinical Research Department, Whitehall-Robins Healthcare, Madison, NJ 07940, USA. kellstd@ahp.com
Lipton
R B
RB
Geetha
R
R
Koronkiewicz
K
K
Evans
F T
FT
Stewart
W F
WF
Wilkes
K
K
Furey
S A
SA
Subramanian
T
T
Cooper
S A
SA
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
D018712:Analgesics, Non-Narcotic; D005782:Gels; D010919:Placebos; D007052:Ibuprofen