Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Migraine Disorders; Migraine

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00240630

TRX103632

Details and patient eligibility

About

The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), 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: 646 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

---

646 participants in 2 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

placebo to match

Treatment:

Drug: sumatriptan succinate/naproxen sodium

Arm 2

Experimental group

Description:

Treximet (sumatriptan/naproxen sodium)

Treatment:

Drug: placebo