Status:
COMPLETED
Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea
Lead Sponsor:
GlaxoSmithKline
Conditions:
Migraine Disorders
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
This study was designed to determine efficacy of 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 :
320 Patients enrolled
Trial Details
Trial ID
NCT00329459
Start Date
May 1 2006
End Date
November 1 2006
Last Update
October 24 2016
Active Locations (34)
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1
GSK Investigational Site
Mesa, Arizona, United States, 85201
2
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
3
GSK Investigational Site
Fair Oaks, California, United States, 95628
4
GSK Investigational Site
Newport Beach, California, United States, 92660