Premium
Solubilized Ibuprofen: Evaluation of Onset, Relief, and Safety of a Novel Formulation in the Treatment of Episodic Tension‐type Headache
Author(s) -
Packman Barry,
Packman Elias,
Doyle Geraldine,
Cooper Stephen,
Ashraf Elizabeth,
Koronkiewicz Karen,
Jayawardena Shyamalie
Publication year - 2000
Publication title -
headache: the journal of head and face pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.14
H-Index - 119
eISSN - 1526-4610
pISSN - 0017-8748
DOI - 10.1046/j.1526-4610.2000.00087.x
Subject(s) - ibuprofen , acetaminophen , placebo , medicine , analgesic , anesthesia , pain relief , pharmacology , alternative medicine , pathology
Objective.—To evaluate the relative efficacy of a new solubilized formulation 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; acetaminophen, 1000 mg; or placebo for the relief of episodic tension‐type headache. Time to relief was measured using a stopwatch, and overall efficacy was measured using traditional categorical pain and relief scales.Results.—Ibuprofen capsules (liquigel), 400 mg, were significantly faster than both acetaminophen, 1000 mg, and placebo for all time‐to‐relief measures. 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 time of 39 minutes compared with 53 minutes for acetaminophen and more than 180 minutes for placebo ( P .02 for both measures). In addition, ibuprofen liquigels demonstrated significantly superior overall analgesic efficacy compared with acetaminophen, 1000 mg, for the relief of episodic tension‐type headache. Both active treatments had a side effect profile similar to placebo.Conclusions.—Although several other studies have demonstrated the overall analgesic superiority of ibuprofen to acetaminophen, this study demonstrated that the liquigel formulation also provides a clinically relevant advantage for time to analgesic effects.