Conditions: Migraine, Without Aura
Keywords: sumatriptan succinate, naproxen sodium, parallel group, double-blind, placebo-controlled, Combination product, migrainous headache Probable migraine, a sub-type of Migraine probable migraine,
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 679
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: sumatriptan succinate / naproxen sodium intervention 2: Placebo
Intervention descriptions: intervention 1: sumatriptan 85mg / naproxen sodium 500mg intervention 2: Placebo to match Treximet tablets

Protocol document: