To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches

Summary

* to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate 85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine * to demonstrate the superiority of Trexima versus the individual components (sumatriptan as the succinate 85 mg and naproxen sodium 500 mg), and * to evaluate the safety of the Trexima.

Timeline

Start

2004-07

Primary completion

—

Completion

2005-01

Outcome

Met primary endpoint

paper Sumatriptan-naproxen sodium was more effective than placebo for headache relief at 2 hours after dosing (study 1, 65% vs 28%; P<.001 PMID 17405970 ↗

paper The absence of nausea 2 hours after dosing was higher with sumatriptan-naproxen sodium than placebo in study 1 (71% vs 65%; P = .007) PMID 17405970 ↗

paper For 2- to 24-hour sustained pain-free response, sumatriptan-naproxen sodium was superior at P<.01 PMID 17405970 ↗

Publications

• Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. doi: 10.1001/jama.297.13.1443.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naproxen	Small molecule	500 mg	—
Subject	Sumatriptan	Unknown	85 mg	—

Indications