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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00240630
Other study ID # TRX103632
Secondary ID
Status Completed
Phase Phase 3
First received October 14, 2005
Last updated April 15, 2015
Start date October 2005
Est. completion date June 2006

Study information

Verified date April 2015
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 646
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
sumatriptan succinate/naproxen sodium
Combination Tablet of Treximet
placebo
placebo to match

Locations

Country Name City State
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Austell Georgia
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Braintree Massachusetts
United States GSK Investigational Site Burlington Vermont
United States GSK Investigational Site Chandler Arizona
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Colorado Springs Colorado
United States GSK Investigational Site Daytona Beach Florida
United States GSK Investigational Site Endwell New York
United States GSK Investigational Site Eugene Oregon
United States GSK Investigational Site Fargo North Dakota
United States GSK Investigational Site Fort Wayne Indiana
United States GSK Investigational Site Georgetown Texas
United States GSK Investigational Site Germantown Tennessee
United States GSK Investigational Site Hartford Connecticut
United States GSK Investigational Site Hollywood Florida
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Irvine California
United States GSK Investigational Site Kalamazoo Michigan
United States GSK Investigational Site Las Vegas Nevada
United States GSK Investigational Site Little Rock Arkansas
United States GSK Investigational Site Manhasset New York
United States GSK Investigational Site Manlius New York
United States GSK Investigational Site Medford Oregon
United States GSK Investigational Site Milford Massachusetts
United States GSK Investigational Site Minneapolis Minnesota
United States GSK Investigational Site Mount Pleasant South Carolina
United States GSK Investigational Site Nashville Tennessee
United States GSK Investigational Site New York New York
United States GSK Investigational Site Newport Beach California
United States GSK Investigational Site Oklahoma City Oklahoma
United States GSK Investigational Site Palm Beach Gardens Florida
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Salt Lake City Utah
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Francisco California
United States GSK Investigational Site Santa Monica California
United States GSK Investigational Site Seattle Washington
United States GSK Investigational Site Stamford Connecticut
United States GSK Investigational Site Tulsa Oklahoma
United States GSK Investigational Site Walnut Creek California
United States GSK Investigational Site West Palm Beach Florida
United States GSK Investigational Site Westlake Village California
United States GSK Investigational Site Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Score on a migraine pain scale for multiple migraine attacks 2 to 24 hours
Secondary 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
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