To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches
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|ClinicalTrials.gov Identifier: NCT00434083|
Recruitment Status : Completed
First Posted : February 12, 2007
Last Update Posted : February 12, 2007
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headaches||Drug: sumatriptan Drug: naproxen sodium||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-Blind Multicenter, Randomized, Placebo-Controlled Single Dose Study to Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches|
|Study Start Date :||July 2004|
|Study Completion Date :||January 2005|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434083
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27517|
|United States, Tennessee|
|Nashville Neuroscience Group, PC|
|Nashville, Tennessee, United States, 37203|
|Study Director:||David Taylor||POZEN|