Last updated: 11/04/2018 12:58:24
Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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
Trial description: The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), 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 experienced a sustained headache pain free response from 2 to 24 hours after treatment (TREXIMA vs. placebo) of each attack
Timeframe: 2 to 24 hours after treatment of each attack
Percentage of participants who became headache pain free at 2 hours after treatment (TREXIMA vs. placebo) of each attack
Timeframe: At 2 hours after treatment of each attack
Secondary outcomes:
Percentage of Participants Who Become Headache Pain Free at 2, 3, and 4 hours After Treatment in at Least 1 of the First 2 Attacks
Timeframe: Up to 4 hours after treatment in at least 1 of the first 2 attacks
Percentage of participants who became headache pain free 2 hours after treatment of Trexima in at least 1 of 2 attacks, 2 of 3 attacks, 3 of 3 attacks, 3 of 4 attacks, and 4 of 4 attacks
Timeframe: 2 hours after treatment of 4 attacks
Percentage of participants who became headache pain free 2 hours after treatment in all attacks treated
Timeframe: 2 hours after treatment in all attacks
Percentage of participants who become headache pain free 2 hours after treatment of any attack
Timeframe: 2 hours after treatment
Of the participants who become headache pain free 2 hours after treatment of attack 1, the percentage of participants who become headache pain free 2 hours after treatment of the next attack treated with TREXIMA
Timeframe: 2 hours after treatment of attack 2
Of the participants who fail to become headache pain free 2 hours after treatment of attack 1, the percentage of participants who become headache pain free 2 hours after treatment of the next attack treated with TREXIMA
Timeframe: Upto 2 hours after treatment of attack 2
Percentage of participants who become headache pain free at 30 minutes, 1, 3, and 4 hours after treatment
Timeframe: 30 minutes, 1, 3, and 4 hours after treatment in each attack
Percentage of participants with nausea, photophobia and phonophobia at 2 and 4 hours after treatment in each migraine attack
Timeframe: At 2 and 4 hours after treatment for each attack
Percentage of participants who, after becoming headache pain free at 2 hours, have a return of headache pain 2 to 24 hours after treatment for each migraine attack
Timeframe: 2 to 24 hours after treatment for each migraine attack
Number of participants migraine free (a composite endpoint of free from headache pain, nausea, photophobia, and phonophobia) at 2 and 4 hours after treatment for each migraine attack
Timeframe: At 2 and 4 hours after treatment for each migraine attack
Number of participants with neck pain/discomfort and sinus pain/pressure at 2, 3, 4, and 6 hours after treatment for each attack
Timeframe: At 2, 3, 4 and 6 hours after treatment for each attack
Number of participants with adverse events (AE) and serious adverse events (SAE) and severity of adverse events
Timeframe: From Visit 2 (start of study drug) up to Final visit (between 4 and 10 days after 4th or last attack)
Interventions:
Enrollment:
646
Primary completion date:
2006-07-06
Observational study model:
Not applicable
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, Adelman JU, Aurora SK, Lener SE, White J, Nelsen A. Within Person Consistency Across 4 Migraine Attacks of a Fixed Single Tablet Formulation of Sumatriptan 85mg RT Technology and Naproxen Sodium 500mg (SumaRT/Nap). Neurology 2007; Vol 68 (Suppl 1): A194-195.
Burch SP, Cady R, Goldstein J, O’Donnell F, Runken MC. Consistent medication satisfaction with Sumatriptan RT TechnologyTM and Naproxen for acute migraine treatment. Cephalalgia 2007; Vol 27; 702.
Dodick D, Kaniecki R, Kori S, Mathew N, McDonald S, Nelsen A. Incidence and Responsiveness of Traditional and Non-traditional Migraine-Associated Symptoms. Cephalalgia 2007; Vol 27 (6); 728.
Dodick D, Kaniecki R, Mathew N, Kori S, McDonald SA, Nelsen A. Traditional and Non-Traditional Migraine-Associated Symptoms: Incidence and Consistent Responsiveness Across 4 Migraine Attacks With Sumatriptan 85mg RT Technology and Naproxen Sodium 500mg (SumaRT/Nap) Neurology 2007; Vol 68 (Suppl 1): A195.
Dodick D, Lipton R, Silberstein S, Kori S, McDonald S, Nelsen, A. Opportunity for Early Intervention in a Clinical Trial Setting. Cephalalgia 2007; 27(10); 1196
Landy S, Adelman J, Cady R, White J, Nelsen A, Runken MC. Assessing the Relationship of Functioning to Pain Endpoints in Migraine Sufferers Treated with a single-tablet of Sumatriptan RTTM and Naproxen Sodium (SumaRT/Nap) versus Placebo. Neurology 2008: A354.
Landy S, Freitag F, Smith T, Burch S, White J, Runken MC. Assessing workplace productivity and activity time in migraineurs treated with a single-tablet of Sumatriptan formulated with RT TechnologyTM and Naproxen Sodium (SumaRT/NAP) and Placebo. Neurology 2007; Vol 68 (Suppl 1): A265.
Lipton R, Adelman J, Aurora S, Lener S, White J Nelsen A. Within Person Consistency Across 4 Migraine Attacks of a Fixed Single Tablet Formulation of Sumatriptan 85mg RT Technology and Naproxen Sodium 500mg (SumaRT/Nap). Cephalalgia 2007; Vol 27 (6); 758.
Lipton RB, Adelman JU, Dodick DW, Kaniecki RG, Kori SH, Lener SE, White JD, Nelsen AC. Consistent efficacy and tolerability across 4 migraine attacks of a fixed single-tablet formulation of sumatriptan 85mg RT Technology™ and naproxen sodium 500mg (SumaRT/Nap). Cephalalgia 2006;26 (Suppl 11);1395 (Abs No PE.20).
Sheftell F, Winner P, Finkel A, White J, Lener S, Nelsen A. Consistent Sustained Efficacy across 4 Migraine Attacks with a Fixed Single-Tablet Formulation of Sumatriptan 85mg RT Technology™ and Naproxen Sodium 500mg (SumaRT/Nap). Headache 2007; 47(5):769.
Winner P, Aurora S, Mathew N, Kori S, Lener S, Nelsen A. Migraine Free Rates Across Four Attacks Treated with a Fixed Single-Tablet Formulation of Sumatriptan 85mg RT Technology™ and Naproxen Sodium 500mg vs Placebo. Cephalalgia 2007; Vol 27 (10);1191.
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
Newport Beach, California, United States, 92660
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33021
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98122
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94596
Status
Study Complete
Location
GSK Investigational Site
Milford, Massachusetts, United States, 01757
Status
Study Complete
Location
GSK Investigational Site
Manhasset, New York, United States, 11030
Status
Study Complete
Location
GSK Investigational Site
Burlington, Vermont, United States, 05405
Status
Study Complete
Location
GSK Investigational Site
Westlake Village, California, United States, 91361
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10022
Status
Study Complete
Location
GSK Investigational Site
Medford, Oregon, United States, 97504-8456
Status
Study Complete
Location
GSK Investigational Site
Endwell, New York, United States, 13760
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
Braintree, Massachusetts, United States, 02184
Status
Study Complete
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46805
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Fargo, North Dakota, United States, 58122
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85013
Status
Study Complete
Location
GSK Investigational Site
Stamford, Connecticut, United States, 06902
Status
Study Complete
Location
GSK Investigational Site
Germantown, Tennessee, United States, 38138
Status
Study Complete
Location
GSK Investigational Site
Austell, Georgia, United States, 30106
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94109
Status
Study Complete
Location
GSK Investigational Site
Manlius, New York, United States, 13104
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80904
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55422
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78258
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Palm Beach Gardens, Florida, United States, 33410
Status
Study Complete
Location
GSK Investigational Site
Daytona Beach, Florida, United States, 32114
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Irvine, California, United States, 92618
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60614
Status
Study Complete
Location
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Hartford, Connecticut, United States, 06106
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107-2568
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89146
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
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.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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