Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Naproxen; Sumatriptan

Criteria

Inclusion Criteria:

• At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month.

• Typically experiences moderate to severe migraine pain preceded by a mild pain phase.

• Differentiate between mild migraine pain and other headache types.

• Women of childbearing potential must be on adequate contraception.

Exclusion Criteria:

• Pregnant and/or nursing mother.

• History of cardiovascular disease.

• Uncontrolled hypertension.

• Basilar or Hemiplegic migraine.

• History of stroke or transient ischemic attacks (TIA).

• History of epilepsy or treated with anti-epileptics within past 5 years.

• Impaired hepatic or renal function.

• History of gastrointestinal bleeding or ulceration.

• Allergy or hypersensitivity to aspirin or any other NSAID.

• Allergy or hypersensitivity to triptans.

• Participated in an investigational drug trial in the previous 4 weeks.