Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Migraine Disorders

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00240617

TRX103635

Details and patient eligibility

About

The purpose of this study is to determine the consistency of response for Treximet (formerly known as Trexima) when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.

Enrollment: 623 patients

Sex: All

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: Crossover Assignment

Masking: Double Blind

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623 participants in 2 patient groups, including a placebo group

arm 1

Active Comparator group

Description:

Treximet (sumatriptan/naproxen sodium) formerly known as TREXIMA

Treatment:

Drug: sumatriptan succinate/naproxen sodium

arm 2

Placebo Comparator group

Description:

placebo to match

Treatment:

Drug: placebo