CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 147 enrolled
Drug / intervention
sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)drug
Likely dose
sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)from record
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Search/NCT00893737
NCT00893737Phase 4Completed
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An Open-label Study to Evaluate "Completeness of Response" Following Treatment With Treximet™ for Migraine

Cady, Roger, M.D.·interventional·Posted May 6, 2009·Updated Jan 25, 2011

In Brief

A Phase 4 clinical trial evaluating sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet) for Migraine. Completed, enrolled 147 participants across 8 sites.

Detailed Summary

Many clinical trials may not fully explore criteria that are important to some migraine patients' definition of "complete response." This study offers the opportunity to evaluate the effectiveness of Treximet™ when non-standard criteria are examined (for example, neck pain, irritability or fatigue). Subjects enrolled at 8 investigative sites will complete 2 visits. Subjects will complete a Completeness of Response Survey at Visit 1 considering their usual migraine medication (a triptan) and a Completeness of Response Survey at Visit 2 considering their study medication (Treximet™).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 6, 2009
Enrollment StartJun 1, 2009
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.2 years ago

Interventions

sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)drug

Treximet 1 tablet as soon as the patient has headache indicative of migraine. May be repeated between 2 and 24 hours post-treatment for persistent or recurring headache. Subjects should not take more than 2 Treximet tablets in 24 hours.