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Clinical Trial Summary

This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.


Clinical Trial Description

A randomized, double-blind, single migraine attack, placebo-controlled, parallel group, multicenter study to evaluate the efficacy and tolerability of TREXIMA* (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea. (TREXIMET was formerly known as TREXIMA) ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00329459
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date May 2006
Completion date November 2006

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