To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- Trexima will be evaluated for efficacy as an acute treatment for migraine based on its superiority over placebo at 2 hours for: a) pain relief (no or mild pain), b) incidence of photophobia, c) incidence of phonophobia and d) incidence of nausea.
- a) sustained pain relief over 24 hours, b) sustained photophobia-free over 24 hours, c) sustained phonophobia-free over 24 hours, and d) sustained nausea-free over 24 hours.
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||April 2005|
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.
|United States, Arkansas|
|Little Rock Family Practice Clinic|
|Little Rock, Arkansas, United States, 72205|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27517|
|Study Director:||David Taylor||POZEN|