Last updated: 11/04/2018 13:01:21
TREXIMET (formerly known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: 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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Pain-Free at 2 hours post-dose and Sustained Pain-Free from 2-24 hours post-dose.
Timeframe: 2 hours through 24 hours after Treatment
Secondary outcomes:
Freedom from Headache pain at 0.5, 1, and 4 hours after Treatment
Timeframe: 0.5, 1, and 4 hours after Treatment
Sustained headache relief 2-24 hours after Treatment
Timeframe: 2-24 hours after treatment
Headache relief at 4, 2, 1 and 0.5 hours after treatment
Timeframe: 0.5, 1, 2, and 4 hours after treatment
Subjects who used Rescue medication from 0 - 24 hours after treatment
Timeframe: 0 - 24 hours after treatment
Intermediate Sustained Pain Relief: Post-dose at intervals of 2-4 hours and 1-2 hours after treatment
Timeframe: 1-2, and 2- 4 hours after treatment
Intermediate Sustained Pain-Free: Post-dose at intervals of 2-4 hours and 1-2 hours
Timeframe: 1-2 and 2-4 hours after treatment
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at time intervals of 4 and 2 hours after treatment
Timeframe: 2 and 4 hours after treatment
Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score
Timeframe: 0 - 24 hours after treatment
Interventions:
Enrollment:
679
Primary completion date:
2008-20-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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.
Stephen Silberstein, Susan A. McDonald, Jerome Goldstein, Sheena Aurora, Shelly E. Lener, Jonathan White, Michael C. Runken, Jane Saiers.Sumatriptan/Naproxen Sodium for the Acute Treatment of Probable Migraine Without Aura .Cephalalgia.2014;34(4):268-279
Medical condition
Migraine, Without Aura
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
September 2006 to February 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- At least a 6 month history of probably migraine (6 migraine attacks per month)
- Males and women of childbearing potential on a adequate contraception.
- Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use
- Pregnant and/or nursing mother
Inclusion and exclusion criteria
Inclusion criteria:
- At least a 6 month history of probably migraine (6 migraine attacks per month) -Males and women of childbearing potential on a adequate contraception.
Exclusion criteria:
- 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.
Trial location(s)
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85014
Status
Study Complete
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209-0996
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94596
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70121
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94109
Status
Study Complete
Location
GSK Investigational Site
Independence, Ohio, United States, 44131
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80904
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
Location
GSK Investigational Site
Valley Stream, New York, United States, 11580
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77030
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Study Complete
Location
GSK Investigational Site
Alexandria, Virginia, United States, 22311
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
West Jordan, Utah, United States, 84084
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Westlake Village, California, United States, 91361
Status
Study Complete
Location
GSK Investigational Site
Westerville, Ohio, United States, 43081
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10022
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Anderson, South Carolina, United States, 29621
Status
Study Complete
Location
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Status
Study Complete
Location
GSK Investigational Site
Richardson, Texas, United States, 75080
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12206
Status
Study Complete
Location
GSK Investigational Site
Stamford, Connecticut, United States, 06902
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92128
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89146
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Study Complete
Location
GSK Investigational Site
St. Louis Park, Minnesota, United States, 55426
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60614
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98195
Status
Study Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48104
Status
Study Complete
Location
GSK Investigational Site
Buena Park, California, United States, 90620
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Location
GSK Investigational Site
Springfield, Missouri, United States, 65804
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
Status
Study Complete
Location
GSK Investigational Site
Medford, Oregon, United States, 97504-8456
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98104
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14642
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92805
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45245
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107-2568
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92660
Status
Study Complete
Location
GSK Investigational Site
Diamond Bar, California, United States, 91765
Status
Study Complete
Location
GSK Investigational Site
West Chester, Ohio, United States, 45069
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47712
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2008-20-02
Actual study completion date
2008-20-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website