Status:
COMPLETED
Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
Lead Sponsor:
GlaxoSmithKline
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ons...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
623 Patients enrolled
Trial Details
Trial ID
NCT00240617
Start Date
October 1 2005
End Date
June 1 2006
Last Update
October 26 2016
Active Locations (52)
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1
GSK Investigational Site
Anniston, Alabama, United States, 36207
2
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
3
GSK Investigational Site
Mesa, Arizona, United States, 85201
4
GSK Investigational Site
Phoenix, Arizona, United States, 85032