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Randomized Controlled Trial Multicenter Study Clinical Trial
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, and S A Cooper.
- Clinical Research Department, Whitehall-Robins Healthcare, Madison, NJ 07940, USA. kellstd@ahp.com
- Cephalalgia. 2000 May 1; 20 (4): 233-43.
AbstractA 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.
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