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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Migraine Disorders

Treatments: Drug: sumatriptan succinate/naproxen sodium; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00329459

TRX105850

Details and patient eligibility

About

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

Full description

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)

Enrollment: 320 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 2 patient groups, including a placebo group

arm 1

Experimental group

Description:

Treximet (sumatriptan/naproxen sodium)

Treatment:

Drug: sumatriptan succinate/naproxen sodium

arm 2

Placebo Comparator group

Description:

placebo to match

Treatment:

Drug: placebo