Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
NCT ID: NCT00240630
Last Updated: 2015-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
646 participants
INTERVENTIONAL
2005-10-31
2006-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
NCT00240617
Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea
NCT00329459
To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches
NCT00434083
TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
NCT00387881
Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents
NCT00488514
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
placebo to match
sumatriptan succinate/naproxen sodium
Combination Tablet of Treximet
Arm 2
Treximet (sumatriptan/naproxen sodium)
placebo
placebo to match
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
sumatriptan succinate/naproxen sodium
Combination Tablet of Treximet
placebo
placebo to match
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Irvine, California, United States
GSK Investigational Site
Newport Beach, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Santa Monica, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
Westlake Village, California, United States
GSK Investigational Site
Colorado Springs, Colorado, United States
GSK Investigational Site
Hartford, Connecticut, United States
GSK Investigational Site
Stamford, Connecticut, United States
GSK Investigational Site
Daytona Beach, Florida, United States
GSK Investigational Site
Hollywood, Florida, United States
GSK Investigational Site
Palm Beach Gardens, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Austell, Georgia, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Fort Wayne, Indiana, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Braintree, Massachusetts, United States
GSK Investigational Site
Milford, Massachusetts, United States
GSK Investigational Site
Kalamazoo, Michigan, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Endwell, New York, United States
GSK Investigational Site
Manhasset, New York, United States
GSK Investigational Site
Manlius, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Fargo, North Dakota, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Tulsa, Oklahoma, United States
GSK Investigational Site
Eugene, Oregon, United States
GSK Investigational Site
Medford, Oregon, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, United States
GSK Investigational Site
Germantown, Tennessee, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Georgetown, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Burlington, Vermont, United States
GSK Investigational Site
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TRX103632
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.