TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of TREXIMA* (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1) (*TREXIMET)
1 other identifier
interventional
679
1 country
70
Brief Summary
This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2006
70 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
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 11, 2006
CompletedFirst Posted
Study publicly available on registry
October 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
July 10, 2009
CompletedDecember 16, 2016
November 1, 2016
1.4 years
October 11, 2006
February 19, 2009
November 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.
Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.
2 hours through 24 hours after Treatment
Secondary Outcomes (8)
Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment
0.5, 1, and 4 hours after Treatment
Sustained Headache Relief 2-24 Hours After Treatment
2-24 hours after treatment
Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment
0.5, 1, 2, and 4 hours after treatment
Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment
0 - 24 hours after treatment
Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment
1-2, and 2- 4 hours after treatment
- +3 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORTreximet
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- At least a 6 month history of probably migraine (6 migraine attacks per month)
- Males and women of childbearing potential on a adequate contraception.
You may not qualify if:
- Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use
- 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 the 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 (70)
GSK Investigational Site
Phoenix, Arizona, 85014, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Anaheim, California, 92801, United States
GSK Investigational Site
Anaheim, California, 92805, United States
GSK Investigational Site
Buena Park, California, 90620, United States
GSK Investigational Site
Diamond Bar, California, 91765, United States
GSK Investigational Site
Newport Beach, California, 92660, United States
GSK Investigational Site
San Diego, California, 92128, 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
Stamford, Connecticut, 06902, United States
GSK Investigational Site
Miami, Florida, 331144, United States
GSK Investigational Site
Pembroke Pines, Florida, 33024, United States
GSK Investigational Site
West Palm Beach, Florida, 33407, United States
GSK Investigational Site
Atlanta, Georgia, 30033, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Chicago, Illinois, 60614, United States
GSK Investigational Site
Evansville, Indiana, 47712, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
New Orleans, Louisiana, 70121, United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747, United States
GSK Investigational Site
Ann Arbor, Michigan, 48104, United States
GSK Investigational Site
Kalamazoo, Michigan, 49009, United States
GSK Investigational Site
Saint Louis Park, Minnesota, 55426, United States
GSK Investigational Site
Springfield, Missouri, 65804, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Las Vegas, Nevada, 89146, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Albany, New York, 12206, United States
GSK Investigational Site
New York, New York, 10022, United States
GSK Investigational Site
Rochester, New York, 14642, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
Valley Stream, New York, 11580, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599, United States
GSK Investigational Site
Greensboro, North Carolina, 27401, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Cincinnati, Ohio, 45245, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Independence, Ohio, 44131, United States
GSK Investigational Site
West Chester, Ohio, 45069, United States
GSK Investigational Site
Westerville, Ohio, 43081, United States
GSK Investigational Site
Medford, Oregon, 97504-8456, United States
GSK Investigational Site
Carnegie, Pennsylvania, 15106, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107-2568, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236, United States
GSK Investigational Site
Anderson, South Carolina, 29621, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Austin, Texas, 78745, United States
GSK Investigational Site
Bellaire, Texas, 77401, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Katy, Texas, 77450, United States
GSK Investigational Site
Richardson, Texas, 75080, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Salt Lake City, Utah, 84107, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
West Jordan, Utah, 84084, United States
GSK Investigational Site
Alexandria, Virginia, 22311, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
GSK Investigational Site
Seattle, Washington, 98195, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53209-0996, United States
Related Publications (1)
Silberstein S, Lipton RB, Goldstein J, Aurora SK, White J, Ochs-Ross R, Lener SE, McDonald SA. Evaluation of a New Fixed-dose Single Tablet of Sumatriptan Formulated with RT Technology and Naproxen Sodium (SumaRT/Nap) for the Acute Treatment of Probable Migraine without Aura. Headache 2008: presented at the American Headache Society Meeting, Boston, MA.
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2006
First Posted
October 13, 2006
Study Start
September 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
December 16, 2016
Results First Posted
July 10, 2009
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.