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

Phase 3

Completed

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

• Registration Number: NCT00240617
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

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: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 623

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 2	placebo	placebo to match
arm 1	sumatriptan succinate/naproxen sodium	Treximet (sumatriptan/naproxen sodium) formerly known as TREXIMA

Primary Outcome Measures

Name	Time	Method
Score on a 4 pt 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; 🇺🇸 Wenatchee, Washington, United States