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

Phase 3

Completed

• Conditions: Migraine; Migraine Disorders
• Interventions: Drug: sumatriptan succinate/naproxen sodium; Drug: placebo

• Registration Number: NCT00240630
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-18
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 646

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	sumatriptan succinate/naproxen sodium	placebo to match
Arm 2	placebo	Treximet (sumatriptan/naproxen sodium)

Primary Outcome Measures

Name	Time	Method
Score on a migraine pain scale for multiple migraine attacks	2 to 24 hours

Secondary Outcome Measures

Name	Time	Method
Within patient consistency of response, freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, recurrence of head pain, safety and tolerability	2 to 24 hours

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Seattle, Washington, United States