A double-blind, randomized, placebo-controlled, single-dose study of the cyclooxygenase-2 inhibitor, GW406381, as a treatment for acute migraine.

Abstract

The objective of the present study was to explore the clinical efficacy and tolerability of GW406381, a cyclooxygenase-2 (COX-2) inhibitor with relatively high CNS penetration, in acute migraine. This was a double-blind, single-dose study of GW406381 compared with placebo and naproxen sodium compared with placebo (protocol number CXA20008). Three hundred and thirty-seven subjects were randomized 1:1:1 to GW406381 (70 mg), naproxen sodium (825 mg), or placebo for the treatment of one migraine headache of moderate or severe intensity in a potential 8-week period. The primary end-point was the proportion of subjects with headache relief [reduction in headache severity score from pre-dose 2 (moderate) or 3 (severe) to 0 (no pain) or 1 (mild)] at 2 h post-dose for GW406381 compared with placebo. Significantly higher proportions of subjects treated with GW406381 (50%, P = 0.032) or naproxen sodium (56%, P = 0.005) than with placebo (35%) reported headache relief at 2 h post-dose. Additional significant benefits were observed on many secondary outcomes, including proportions of subjects pain-free, for both GW406381 and naproxen sodium treatment compared with placebo. Both active treatments were well tolerated. Single-dose GW406381 (70 mg) and naproxen sodium (825 mg) were effective and well tolerated in the treatment of acute migraine.

• Authors: A L Wentz, T B Jimenez, R M Dixon, S K Aurora, M Gold, CXA20008 Study Investigators
• Journal: European journal of neurology (Eur J Neurol) Vol. 15 Issue 4 Pg. 420-7 (Apr 2008) ISSN: 1468-1331 [Electronic] England
• PMID: 18312401 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Cyclooxygenase 2 Inhibitors
• GW406381X
• Hydrocarbons, Aromatic
• Pyrazoles
• Pyridazines
• Naproxen
• Nitrogen

Topics

• Adolescent
• Adult
• Aged
• Cyclooxygenase 2 Inhibitors (therapeutic use)
• Double-Blind Method
• Drug Evaluation
• Female
• Humans
• Hydrocarbons, Aromatic (therapeutic use)
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Naproxen (therapeutic use)
• Nitrogen (therapeutic use)
• Pain Measurement
• Pyrazoles
• Pyridazines
• Statistics, Nonparametric
• Time Factors