This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
320
placebo to match
Score on a 4-point migraine pain scale for a single menstrual migraine attack
Time frame: 2 to 48 hours
Freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, menstrual symptoms, recurrence of head pain, safety and tolerability
Time frame: from 2 to 48 hours
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Mesa, Arizona, United States
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Little Rock, Arkansas, United States
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Fair Oaks, California, United States
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Newport Beach, California, United States
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Miami, Florida, United States
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Atlanta, Georgia, United States
...and 24 more locations