Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
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
1 other identifier
interventional
646
1 country
50
Brief Summary
The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2005
Shorter than P25 for phase_3
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 14, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedApril 16, 2015
April 1, 2015
8 months
October 14, 2005
April 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score on a migraine pain scale for multiple migraine attacks
2 to 24 hours
Secondary Outcomes (1)
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
Study Arms (2)
Arm 1
PLACEBO COMPARATORplacebo to match
Arm 2
EXPERIMENTALTreximet (sumatriptan/naproxen sodium)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (50)
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Phoenix, Arizona, 85013, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Irvine, California, 92618, United States
GSK Investigational Site
Newport Beach, California, 92660, United States
GSK Investigational Site
San Francisco, California, 94109, United States
GSK Investigational Site
Santa Monica, California, 90404, United States
GSK Investigational Site
Walnut Creek, California, 94596, United States
GSK Investigational Site
Westlake Village, California, 91361, United States
GSK Investigational Site
Colorado Springs, Colorado, 80904, United States
GSK Investigational Site
Hartford, Connecticut, 06106, United States
GSK Investigational Site
Stamford, Connecticut, 06902, United States
GSK Investigational Site
Daytona Beach, Florida, 32114, United States
GSK Investigational Site
Hollywood, Florida, 33021, United States
GSK Investigational Site
Palm Beach Gardens, Florida, 33410, United States
GSK Investigational Site
West Palm Beach, Florida, 33407, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Austell, Georgia, 30106, United States
GSK Investigational Site
Chicago, Illinois, 60614, United States
GSK Investigational Site
Fort Wayne, Indiana, 46805, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Braintree, Massachusetts, 02184, United States
GSK Investigational Site
Milford, Massachusetts, 01757, United States
GSK Investigational Site
Kalamazoo, Michigan, 49009, United States
GSK Investigational Site
Minneapolis, Minnesota, 55422, United States
GSK Investigational Site
Las Vegas, Nevada, 89146, United States
GSK Investigational Site
Endwell, New York, 13760, United States
GSK Investigational Site
Manhasset, New York, 11030, United States
GSK Investigational Site
Manlius, New York, 13104, United States
GSK Investigational Site
New York, New York, 10022, United States
GSK Investigational Site
Fargo, North Dakota, 58122, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Tulsa, Oklahoma, 74136, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Medford, Oregon, 97504-8456, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107-2568, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
GSK Investigational Site
Germantown, Tennessee, 38138, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Georgetown, Texas, 78626, United States
GSK Investigational Site
Houston, Texas, 77004, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
GSK Investigational Site
Salt Lake City, Utah, 84107, United States
GSK Investigational Site
Burlington, Vermont, 05405, United States
GSK Investigational Site
Seattle, Washington, 98122, United States
Related Publications (1)
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.
PMID: 20855373RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2005
First Posted
October 18, 2005
Study Start
October 1, 2005
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
April 16, 2015
Record last verified: 2015-04