Last updated: 11/04/2018 12:59:47
Menstrual Migraine Treatment With TREXIMET (formerly known as TREXIMA)
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, parallel-group multicenter study to evaluate the efficacy and tolerability of 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 TREXIMET (sumatriptan/naproxen sodium), formerly known as 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-pt 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: 2 to 48 hours
Interventions:
Drug: sumatriptan succinate/naproxen sodium
Enrollment:
351
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Durham PL, Vause CV, Derosier F, McDonald S, Cady R, Martin V. Changes in salivary prostaglandin levels during menstrual migraine with associated dysmenorrhea. Headache. 2010 May;50(5):844-51. 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 dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials. Obstet Gynecol. 2009 Jul;114(1):106-13. doi: 10.1097/AOG.0b013e3181a98e4d.
Durham PL, Vause CV, Derosier F, McDonald S, Cady R, Martin V. Changes in salivary prostaglandin levels during menstrual migraine with associated dysmenorrhea. Headache. 2010 May;50(5):844-51. doi: 10.1111/j.1526-4610.2010.01657.x. Epub 2010 Mar 26.
Mannix LK, Martin VT, Cady RK, Diamond ML, Lener SE, White JD, Derosier FJ, McDonald SA. Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials. Obstet Gynecol. 2009 Jul;114(1):106-13. doi: 10.1097/AOG.0b013e3181a98e4d.
Medical condition
Migraine
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
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98195
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, 19114
Status
Study Complete
Location
GSK Investigational Site
West Chester, Ohio, United States, 45069
Status
Study Complete
Location
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Irvine, California, United States, 92618
Status
Study Complete
Location
GSK Investigational Site
Boulder, Colorado, United States, 80304
Status
Study Complete
Location
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45267
Status
Study Complete
Location
GSK Investigational Site
Georgetown, Texas, United States, 78626
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
Status
Study Complete
Location
GSK Investigational Site
Port Orange, Florida, United States, 32127
Status
Study Complete
Location
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
Status
Study Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48104
Status
Study Complete
Location
GSK Investigational Site
Redondo Beach, California, United States, 90277
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60614
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45245
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10022
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94109
Status
Study Complete
Location
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Sunrise, Florida, United States, 33351
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46601
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
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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