A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET (Sumatriptan + Naproxen Sodium) vs. Butalbital-containing Combination Medications for the Acute Treatment of Migraine When Administered During the Moderate-Severe Migraine Pain, studies 1 and 2 of 2.

Trial Profile

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET (Sumatriptan + Naproxen Sodium) vs. Butalbital-containing Combination Medications for the Acute Treatment of Migraine When Administered During the Moderate-Severe Migraine Pain, studies 1 and 2 of 2.

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Aug 2016

At a glance

  • Drugs Naproxen sodium/sumatriptan (Primary) ; Butalbital/paracetamol/caffeine
  • Indications Migraine with aura; Migraine without aura
  • Focus Therapeutic Use
  • Sponsors GlaxoSmithKline; POZEN
  • Most Recent Events

    • 24 Jun 2012 Results of a secondary analysis presented at the 54th Annual Scientific Meeting of the American Headache Society.
    • 27 Jan 2010 Actual number of patients (427) added as reported by ClinicalTrials.gov.
    • 27 Jan 2010 Actual number of patients (427) added as reported by ClinicalTrials.gov.
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