NCT00433732

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

A Double-Blind, Multicenter, Randomized, Placebo-Controlled Single Dose Study to Evaluate the Safety and Efficacy Opf Trexima in the Acute Treatment of Migraine Headaches

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,400 (planned)
• Sponsor: POZEN · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy of the Trexima versus placebo as assessed by pain relief and the incidences of photophobia, phonophobia and nausea at 2 hours after treatment as the primary endpoints.

Detailed description

The primary objective of this study is to determine the efficacy of the Trexima versus placebo as assessed by pain relief and the incidences of photophobia, phonophobia and nausea at 2 hours after treatment as the primary endpoints. Another objective of this study is to evaluate the efficacy of Trexima when compared to the individual components (sumatriptan and naproxen sodium) using sustained pain-free as the endpoint. It is the intent that this study be sufficiently powered to detect differences that are clinically meaningful and statistically significant in order to meet both objectives.

Conditions

• Migraine Headaches

Interventions

Type	Name	Description
DRUG	sumatriptan
DRUG	naproxen sodium

Timeline

• Start date: 2004-08-01
• Completion: 2005-04-01
• First posted: 2007-02-12
• Last updated: 2007-02-12

Locations

2 sites across 1 country: United States