Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents
Study TXA107977, a Long-Term Safety Study of a Combination Product Containing Sumatriptan Succinate and Naproxen Sodium for the Treatment of Migraine in Adolescents
1 other identifier
interventional
656
1 country
77
Brief Summary
This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2007
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2007
CompletedFirst Posted
Study publicly available on registry
June 20, 2007
CompletedStudy Start
First participant enrolled
July 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2009
CompletedResults Posted
Study results publicly available
September 6, 2010
CompletedMay 18, 2017
October 1, 2016
2.1 years
June 18, 2007
August 6, 2010
April 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With the Indicated Drug-related Adverse Events
The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: \>=2% participants recorded as having at least one occurrence of a reported drug-related AE.
Baseline through End of Study (up to Month 12)
Secondary Outcomes (26)
Number of Participants With Any Adverse Event Categorized by Severity
Baseline through End of Study (up to Month 12)
Number of Participants With Any Adverse Event Categorized Over Time
Baseline through End of Study (up to Month 12)
Number of Participants With Any Adverse Event Categorized by Participant Age
Baseline through End of Study (up to Month 12)
Number of Participants With Any Adverse Event Categorized by Participant Race
Baseline through End of Study (up to Month 12)
Number of Participants With Any Adverse Event Categorized by Participant Gender
Baseline through End of Study (up to Month 12)
- +21 more secondary outcomes
Study Arms (1)
Active Drug
OTHERCombination Tablet of Treximet (sumatriptan/naproxen sodium)
Interventions
Combination Tablet of Treximet(sumatriptan/naproxen sodium)
Eligibility Criteria
You may qualify if:
- Subject is between 12 and 17 years old at the Screening visit.
- If subject is female, she must have a negative urine pregnancy test at screening, does not plan to become pregnant during the course of the study and agrees to use an acceptable method of birth control (i.e., a method with a failure rate \<1% or abstinence) if she is/becomes sexually active.
- Subject has migraine with or without aura (2004 ICHD-II criteria).
- Subject has history suggestive of typical migraine attacks with duration of about 2 or more hours (untreated, or unsuccessfully treated).
- Subject has at least 2, but not more than 8, migraine attacks per month in each of the 2 months prior to the Screening visit.
- Subject has at least a 6-month history of moderate to severe migraine attacks, sufficient to establish a definitive diagnosis of migraine.
- Subject is able to distinguish migraine from other headaches (e.g., tension-type headaches).
- Subject and subject's parent or legal guardian are willing and able to provide informed consent prior to entry into this treatment phase of the study.
- Subject and subject's parent or legal guardian are able to read and write English or Spanish.
- Subject is able to understand and complete the electronic device to report treatment information.
You may not qualify if:
- Subject is \< 75 pounds (33.3kg).
- Subject has ≥15 headache days per month in total, retinal (ICHD-II 1.4), basilar (ICHD-II 1.26) or hemiplegic migraine (ICHD-II 1.25), or secondary headaches.
- Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (See Appendix 1, section 11.1).
- Subject has uncontrolled hypertension (See Appendix 2, section 11.2) or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
- Subject has a history of congenital heart disease, cardiac arrhythmias requiring medication, or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
- Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or signs/symptoms consistent with any of the above.
- Subject has evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold; or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening.
- Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
- Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan, NSAID or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma.
- Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a medication that is not stabilized (i.e., change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
- Subject has a recent history of regular use of opioids or barbiturates for treatment of his/her migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months.
- Subject has taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within the 2 weeks prior to screening through 2 weeks post final study treatment.
- Subject history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent.
- Subject has evidence or history of any gastrointestinal surgery or GI ulceration or perforation in the past six months, gastrointestinal bleeding in the past year; or evidence or history of inflammatory bowel disease.
- Subject tests positive for illicit substances on toxicology screen, or has evidence of alcohol or substance abuse within the last year, or any concurrent medical or psychiatric condition which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (77)
GSK Investigational Site
Gilbert, Arizona, 85234, United States
GSK Investigational Site
Phoenix, Arizona, 85014, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Chico, California, 95926, United States
GSK Investigational Site
Fair Oaks, California, 95628, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Fullerton, California, 92835, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Irvine, California, 92618, United States
GSK Investigational Site
La Jolla, California, 92037, United States
GSK Investigational Site
Newport Beach, California, 92660, United States
GSK Investigational Site
Northridge, California, 91325, United States
GSK Investigational Site
Redondo Beach, California, 90277, United States
GSK Investigational Site
Roseville, California, 95678, United States
GSK Investigational Site
Sacramento, California, 92585, United States
GSK Investigational Site
San Francisco, California, 94109, United States
GSK Investigational Site
Santa Monica, California, 90404, United States
GSK Investigational Site
Walnut Creek, California, 94596, United States
GSK Investigational Site
Aurora, Colorado, 80045, United States
GSK Investigational Site
Colorado Springs, Colorado, 80909, United States
GSK Investigational Site
East Hartford, Connecticut, 06118-3239, United States
GSK Investigational Site
Fairfield, Connecticut, 06824, United States
GSK Investigational Site
Loxahatchee Groves, Florida, 33470, United States
GSK Investigational Site
Naples, Florida, 34102, United States
GSK Investigational Site
Pensacola, Florida, 32504, United States
GSK Investigational Site
St. Petersburg, Florida, 33701, United States
GSK Investigational Site
West Palm Beach, Florida, 33407, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Savannah, Georgia, 31405, United States
GSK Investigational Site
Anderson, Indiana, 46011, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Murray, Kentucky, 42071, United States
GSK Investigational Site
Ann Arbor, Michigan, 48104, United States
GSK Investigational Site
Kalamazoo, Michigan, 49008, United States
GSK Investigational Site
Paw Paw, Michigan, 49079, United States
GSK Investigational Site
Protage, Michigan, 49024, United States
GSK Investigational Site
Richland, Michigan, 49083, United States
GSK Investigational Site
Plymouth, Minnesota, 55441, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Omaha, Nebraska, 68130, United States
GSK Investigational Site
Henderson, Nevada, 89014, United States
GSK Investigational Site
New Brunswick, New Jersey, 08901, United States
GSK Investigational Site
Ridgewood, New Jersey, 7450, United States
GSK Investigational Site
Vorhees, New Jersey, 08043, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Albany, New York, 12206, United States
GSK Investigational Site
Amherst, New York, 14226, United States
GSK Investigational Site
Endwell, New York, 13760, United States
GSK Investigational Site
Mount Vernon, New York, 10550, United States
GSK Investigational Site
New York, New York, 10022, United States
GSK Investigational Site
Plainview, New York, 11803, United States
GSK Investigational Site
Rochester, New York, 14609, United States
GSK Investigational Site
Rochester, New York, 14642, United States
GSK Investigational Site
Williamsville, New York, 14221, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Cincinnati, Ohio, 45229, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Columbus, Ohio, 43205, United States
GSK Investigational Site
Westerville, Ohio, 43081, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Medford, Oregon, 97504-8456, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Georgetown, Texas, 78626, United States
GSK Investigational Site
Nassau Bay, Texas, 77058, United States
GSK Investigational Site
Plano, Texas, 79075, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
Charlottesville, Virginia, 22902, United States
GSK Investigational Site
Norfolk, Virginia, 23510, United States
GSK Investigational Site
Bremerton, Washington, 98310, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
Related Publications (1)
McDonald SA, Hershey AD, Pearlman E, Lewis D, Winner PK, Rothner D, Linder SL, Runken MC, Richard NE, Derosier FJ. Long-term evaluation of sumatriptan and naproxen sodium for the acute treatment of migraine in adolescents. Headache. 2011 Oct;51(9):1374-87. doi: 10.1111/j.1526-4610.2011.01965.x. Epub 2011 Jul 28.
PMID: 21797863BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2007
First Posted
June 20, 2007
Study Start
July 13, 2007
Primary Completion
August 1, 2009
Study Completion
August 20, 2009
Last Updated
May 18, 2017
Results First Posted
September 6, 2010
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.