EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents
Trial description: This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants who were pain free at 2 hours post-dose
Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Secondary outcomes:
Number of participants sustained pain-free from 2-24 hours
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of participants photophobia-free at 2 hours post-dose
Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of participants phonophobia-free at 2 hours post-dose
Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of participants pain-free at 1 hour post-dose
Timeframe: 1 hour after single dose of double-blind treatment (Randomization through Week 13)
Number of participants sustained photophobia-free from 2-24 hours
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of participants sustained phonophobia-free from 2-24 hours
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of participants sustained nausea-free from 2-24 hours
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of participants who used rescue medication from 2 to 24 hours post dose
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of participants who used their first dose of rescue medication through the indicated time points
Timeframe: Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of participants nausea-free at 2 hours post-dose
Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Interventions:
Enrollment:
589
Primary completion date:
2010-10-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Brandes JL, Kudrow D, Stark SR, O’Carroll CP, Adelman JU, O’Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA 2007;297(13):1443-1454.
Frederick Derosier, Donald Lewis, Andrew Hershey, Paul Winner, Eric Pearlman, David Rothner, Steven Linder, David Goodman, Theresa Jimenez, Wendy Granberry, M. Chris Runken. Efficacy of Sumatriptan and Naproxen Sodium in the Treatment of Adolescent Migraine: A Randomized Study. Pediatrics. 2012;129(6):e1411-1420
Medical condition
Migraine Disorders
Product
naproxen, sumatriptan, sumatriptan/naproxen
Collaborators
Not applicable
Study date(s)
December 2008 to June 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 17 years
Accepts healthy volunteers
No
- Subjects eligible for enrollment in the study must meet all of the following criteria:
- 1. Subject is >/=12 years of age and </=17 years of age at the Screening Visit.
- Subjects meeting any of the following criteria must not be enrolled in the study:
- 1. Subject is < 74 pounds (33.3 kg).
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects eligible for enrollment in the study must meet all of the following criteria: 1. Subject is >/=12 years of age and
Exclusion criteria:
- Subjects meeting any of the following criteria must not be enrolled in the study: 1. Subject is < 74 pounds (33.3 kg). 2. Subject has ≥15 headache days per month in total (migraine, probable migraine, or tension-type), retinal (ICHD-II 1.4), basilar (ICHD-II 1.2.6), or hemiplegic migraine (ICHD-II 1.2.4), or secondary headaches. 3. Subject, in the investigator’s opinion is likely to have unrecognized cardiovascular or cerebrovascular disease. 4. Subject has uncontrolled hypertension at screening or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker. 5. 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. 6. Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease, or signs/symptoms consistent with any of the above. 7. 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. 8. Subject has a history of impaired hepatic or renal function that, in the investigator’s opinion, contraindicates participation in this study. 9. 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. 10. Subject has used an ergot medication in the previous three months for migraine prophylaxis 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. 11. Subject has a recent history of regular use of opioids or barbiturates for treatment of their 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. 12. 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 two weeks prior to screening through two weeks post treatment. 13. Subject has a history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent. 14. Subject has evidence or history of any gastrointestinal surgery, GI ulceration, or perforation in the past six months, gastrointestinal bleeding in the past year, or evidence or history of inflammatory bowel disease. 15. Subject is pregnant, actively trying to become pregnant, or breast feeding or subject is not willing to have pregnancy test(s). 16. 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. 17. Subject has participated in any investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study.
Trial location(s)
Location
GSK Investigational Site
Terre Haute, Indiana, United States, 47802
Status
Study Complete
Location
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32607
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Fairfield, Connecticut, United States, 06824
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Showing 1 - 6 of 79 Results
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
2010-10-06
Actual study completion date
2010-10-06
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
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