Last updated: 11/04/2018 12:58:46
Study Of Treximet, formerly known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomized, double-blind, multi-center, placebo-controlled, cross-over study to determine the consistency of response for Trexima* (sumatriptan 85mg/naproxen sodium 500mg) administered during the mild pain phase for the acute treatment of multiple migraine attacks (*Treximet)
Trial description: The purpose of this study is to determine the consistency of response for Treximet (formerly known as Trexima) when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Percentage of participants who experience sustained pain free response from 2 to 24 hours after treatment during the mild pain phase of each attack (TREXIMA vs. placebo).
Timeframe: Up to 24 hours after attack
Percentage of participants who became pain free (headache grade 0) at 2 hours after treatment during the mild pain phase of each attack (TREXIMA vs. placebo).
Timeframe: Up to 2 hours after attack
Secondary outcomes:
Percentage of participants who were treated with Trexima and demonstrate consistency of response after treatment in at least 1 of the first 2 attacks
Timeframe: Up to 2 hours after attack
Percentage of participants who were treated with Trexima and demonstrate consistency of response after treatment in at least 1 of 2 attacks, 2 of 3 attacks, 3 of 4 attacks and 4 of 4 attacks.
Timeframe: Up to 2 hours after attack
Percentage of participants who become pain free 2 hours after treatment in all attacks treated.
Timeframe: Up to 2 hours after attack
Percentage of participants who become pain free 2 hours after treatment of any attack.
Timeframe: Up to 2 hours after attack
Of the participants who become pain free (headache grade 0) 2 hours after treatment of attack 1, the percentage of participants who become pain free (headache grade 0) 2 hours after treatment of the next attack treated with TREXIMA.
Timeframe: Up to 2 hours after attack
Of the participants who fail to who become pain free (headache grade 0) 2 hours after treatment of attack 1, the percentage of participants who become pain free (headache grade 0) 2 hours after treatment of the next attack treated with TREXIMA.
Timeframe: Up to 2 hours after attack
Percentage of participants who become headache pain free at 30 minutes, 1, 3, and 4 hours after treatment.
Timeframe: Up to 4 hours after attack
Percentage of participants with nausea, photophobia, and phonophobia at 2 and 4 hours after treatment.
Timeframe: Up to 24 hours after attack
Percentage of participants who, after becoming headache pain free at 2 hours, have a return of headache pain 2-24 hours after treatment.
Timeframe: Up to 24 hours after attack
Percentage of participants migraine free (a composite endpoint free from pain, nausea, vomiting, photophobia, and phonophobia) at 2 and 4 hours after treatment.
Timeframe: Up to 4 hours after attack
Percentage of participants with relief of neck pain/discomfort at 2, 4 and 6 hours after treatment
Timeframe: Up to 6 hours after attack
Percentage of participants with relief of sinus pain/pressure at 2, 4 and 6 hours after treatment
Timeframe: Up to 6 hours after attack
Percentage of participants satisfied with treatment measured by the Patient Perception of Migraine Questionnaire-Revised (PPMQ-R) 24 hours after treatment.
Timeframe: Up to 24 hours after attack
Number of participants with adverse events (AEs), serious adverse events (SAEs) and intensity of AEs
Timeframe: Up to 4 months
Percentage of participants with attacks that become pain free at 2 hours after treatment with investigational product
Timeframe: Up to 2 hours after attack
Percentage of participants with sustained migraine free from 2 to 24 hours after treatment.
Timeframe: Up to 24 hours after attack
Interventions:
Drug: sumatriptan succinate/naproxen sodium
Drug: placebo
Enrollment:
623
Observational study model:
Not applicable
Primary completion date:
2006-07-06
Time perspective:
Not applicable
Clinical publications:
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.
Lipton RB, Dodick DW, Adelman JU, Kaniecki RG, Lener SE, White JD, Nelsen AC. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled, crossover study. Cephalalgia 2009; 29, 826–836 (doi:10.1111/j.1468-2982.2008.01806.x).
Medical condition
Migraine Disorders
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
October 2005 to June 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
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
Rochester, New York, United States, 14609
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92128
Status
Study Complete
Location
GSK Investigational Site
Moorestown, New Jersey, United States, 08057
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92108
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47712
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Study Complete
Location
GSK Investigational Site
Plainview, New York, United States, 11803
Status
Study Complete
Location
GSK Investigational Site
Anniston, Alabama, United States, 36207
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19114
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Study Complete
Location
GSK Investigational Site
Anderson, South Carolina, United States, 29621
Status
Study Complete
Location
GSK Investigational Site
Avon, Connecticut, United States, 06001
Status
Study Complete
Location
GSK Investigational Site
South Daytona, Florida, United States, 32119
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48104
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
St. Louis Park, Minnesota, United States, 55426
Status
Study Complete
Location
GSK Investigational Site
Oceanside, California, United States, 92056
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98195
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
Status
Study Complete
Location
GSK Investigational Site
Boulder, Colorado, United States, 80304
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60607
Status
Study Complete
Location
GSK Investigational Site
Irvine, California, United States, 92618
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12206
Status
Study Complete
Location
GSK Investigational Site
West Chester, Ohio, United States, 45069
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Concinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38105
Status
Study Complete
Location
GSK Investigational Site
Valley Stream, New York, United States, 11580
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76135
Status
Study Complete
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Clarksville, Tennessee, United States, 37043
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Study Complete
Location
GSK Investigational Site
Westerville, Ohio, United States, 43081
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85032
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
Completed
Actual primary completion date
2006-07-06
Actual study completion date
2006-07-06
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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