Status:
COMPLETED
Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Migraine
Migraine Disorders
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.
Detailed Description
A randomized, double-blind, single migraine attack, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and tolerability of TREXIMA\* (sumatriptan succinate/naproxen sodium)...
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 :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT00329355
Start Date
May 1 2006
End Date
November 1 2006
Last Update
January 23 2017
Active Locations (35)
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1
GSK Investigational Site
Chandler, Arizona, United States, 85224
2
GSK Investigational Site
Irvine, California, United States, 92618
3
GSK Investigational Site
Redondo Beach, California, United States, 90277
4
GSK Investigational Site
San Francisco, California, United States, 94109