Solubilized ibuprofen: Evaluation of onset, relief, and safety of a novel formulation in the treatment of episodic tension-type headache

Objective.-To evaluate the relative efficacy of a new solubilized formulati on of ibuprofen compared with acetaminophen caplets. Methods.-This double-blind, randomized, parallel group study evaluated 154 subjects taking a single dose of solubilized ibuprofen, 400 mg; acetaminoph en, 1000 mg; or placebo for the relief of episodic tension-type headache. T ime to relief was measured using a stopwatch, and overall efficacy was meas ured using traditional categorical pain and relief scales. Results.-Ibuprofen capsules (liquigel), 400 mg, were significantly faster t han both acetaminophen, 1000 mg, and placebo for all time-to-relief measure s. Ibuprofen liquigel had a median time to first perceptible pain relief of 39 minutes compared with 47 minutes for acetaminophen and 113 minutes for placebo. For median time to meaningful relief, ibuprofen liquigel had a tim e of 39 minutes compared with 53 minutes for acetaminophen and more than 18 0 minutes for placebo (P less than or equal to.02 for both measures). In ad dition, ibuprofen liquigels demonstrated significantly superior overall ana lgesic efficacy compared with acetaminophen, 1000 mg, for the relief of epi sodic tension-type headache. Both active treatments had a side effect profi le similar to placebo. Conclusions.-Although several other studies have demonstrated the overall a nalgesic superiority of ibuprofen to acetaminophen, this study demonstrated that the liquigel formulation also provides a clinically relevant advantag e for time to analgesic effects.