At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 679 enrolled
Drug / intervention
sumatriptan succinate / naproxen sodium +1 moredrug
Likely dose
sumatriptan succinate / naproxen sodium 85mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of TREXIMA* (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1) (*TREXIMET)
In Brief
A Phase 3 clinical trial evaluating sumatriptan succinate / naproxen sodium and Placebo for Migraine, Without Aura. Completed, enrolled 679 participants across 70 sites.
Detailed Summary
This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine, Without Aura
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2006
First PostedOct 2006
Primary CompletionFeb 2008
TodayJul 2026
First PostedOct 13, 2006
Enrollment StartSep 1, 2006
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.7 years ago
Interventions
sumatriptan succinate / naproxen sodiumdrug
sumatriptan 85mg / naproxen sodium 500mg
Placebodrug
Placebo to match Treximet tablets