Clinical trial NCT00240617: Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima* (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks (*Treximet)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Keywords: consistency of response
migraine
satisfaction
early intervention
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 623
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Score on a 4 pt migraine pain scale for multiple migraine attacks
timeFrame: 2 to 24 hours
Secondary outcomes:
measure: 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
timeFrame: 2 to 24 hours
Other outcomes:
Locations:
city: Anniston
country: United States
facility: GSK Investigational Site
state: Alabama
city: Tuscaloosa
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Irvine
country: United States
facility: GSK Investigational Site
state: California
city: Oceanside
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Boulder
country: United States
facility: GSK Investigational Site
state: Colorado
city: Avon
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: South Daytona
country: United States
facility: GSK Investigational Site
state: Florida
city: Stuart
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Rome
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Baton Rouge
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Ann Arbor
country: United States
facility: GSK Investigational Site
state: Michigan
city: St. Louis Park
country: United States
facility: GSK Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Moorestown
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Plainview
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Valley Stream
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Concinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: West Chester
country: United States
facility: GSK Investigational Site
state: Ohio
city: Westerville
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: GSK Investigational Site
state: Oregon
city: Salem
country: United States
facility: GSK Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Clarksville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Torgovnick J, Sethi NK, Arsura E. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled cross-over study. Cephalalgia. 2010 Oct;30(10):1277; author reply 1277-9. doi: 10.1177/0333102409352810. Epub 2010 May 13. No abstract available.