This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old
The purpose of this study is to determine whether the combination product, sumatriptan and naproxen sodium, is effective compared to placebo in the treatment of acute migraine in adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a \~25 week period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
589
Sumatriptan succinate and naproxen sodium
Placebo to match
Number of Participants Who Were Pain Free at 2 Hours Post-dose
Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.
Time frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Sustained Pain-free From 2-24 Hours
Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication.
Time frame: 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
The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.
Time frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Phonophobia-free at 2 Hours Post-dose
The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.
Time frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Pain-free at 1 Hour Post-dose
Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose.
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GSK Investigational Site
Gilbert, Arizona, United States
GSK Investigational Site
Litchfield Park, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Conway, Arkansas, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Chico, California, United States
GSK Investigational Site
Fresno, California, United States
...and 69 more locations
Time frame: 1 hour after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Sustained Photophobia-free From 2-24 Hours
Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication.
Time frame: 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
Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication.
Time frame: 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
Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication.
Time frame: 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
Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive.
Time frame: 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
Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued \< 2 hours post-treatment.
Time frame: 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
The number of participants who did not have nausea at 2 hours post dose was analzyed.
Time frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)