Last updated: 11/04/2018 12:59:36
Treximet (sumatriptan/naproxen sodium), formerly known as TREXIMA, for menstrual migraine in women with dysmenorrhea
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomized, double-blind, single migraine attack, placebo -controlled, patallel-group multicenter study to evaluate the efficacy and tolerability or Trexima (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea
Trial description: This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Score on a 4-point migraine pain scale for a single menstrual migraine attack
Timeframe: 2 to 48 hours
Secondary outcomes:
Freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, menstrual symptoms, recurrence of head pain, safety and tolerability
Timeframe: from 2 to 48 hours
Interventions:
Drug: sumatriptan succinate/naproxen sodium
Drug: placebo
Enrollment:
320
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Durham PL, Vause CV, Derosier F, McDonald SA, Cady R, Martin V. Changes in salivary prostaglandins during menstrual migraine with associated dysmenorrhea. Headache 2010; 50:844-851 (doi: 10.1111/j.1526-4610.2010.01657.x).
Mannix LK, Martin VT, Cady RK, Diamond ML, Lener SE, White JD, Derosier FJ, McDonald SA. Combination treatment for menstrual migraine and dysmenorrheal using sumatriptan-naproxen: Two randomized controlled trials. Obstet Gynecol 2009; 114(1): 106-113.
Durham PL, Vause CV, Derosier F, McDonald SA, Cady R, Martin V. Changes in salivary prostaglandins during menstrual migraine with associated dysmenorrhea. Headache 2010; 50:844-851 (doi: 10.1111/j.1526-4610.2010.01657.x).
Mannix LK, Martin VT, Cady RK, Diamond ML, Lener SE, White JD, Derosier FJ, McDonald SA. Combination treatment for menstrual migraine and dysmenorrheal using sumatriptan-naproxen: Two randomized controlled trials. Obstet Gynecol 2009; 114(1): 106-113
Vincent Martin, Jeanne Ballard, Michael Diamond, Lisa Mannix, Fred Derosier, Shelly Lener, Alok Krishen, Susan McDonald.Relief of Menstrual Symptoms and Migraine with Single-Tablet Sumatriptan RT and Naproxen Sodium.J Womens Health (Larchmt).2014;23(5)
Medical condition
Migraine Disorders
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
May 2006 to November 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
18 - 65 years
Accepts healthy volunteers
No
- 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.
- Pregnant and/or nursing mother.
- History of cardiovascular disease.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Westerville, Ohio, United States, 43081
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Study Complete
Location
GSK Investigational Site
Moorestown, New Jersey, United States, 08057
Status
Terminated/Withdrawn
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Study Complete
Location
GSK Investigational Site
Springfield, Missouri, United States, 65804
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87102
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92660
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Milford, Massachusetts, United States, 01757
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92128
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33328
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Independence, Ohio, United States, 44131
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Plainview, New York, United States, 11803
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Fair Oaks, California, United States, 95628
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Stamford, Connecticut, United States, 06902
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48201
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12206
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94102
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38018
Status
Study Complete
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-13-11
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.
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