This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). \[Study 2 of 2\]
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design); however, the order of these treatments will be randomized. A minimum 1-week washout period is required between study medication treatment of the first and second migraine attacks. Each subject will have two visits: (1) a Screening visit at study entry and (2) a Final visit 4-10 days after the second (or last) attack. A telephone contact will also be required 1-3 days after the first attack, and then once per month until the Final visit. The primary study objective is to assess efficacy as measured by sustained pain-free (SPF) relief of Combination Product compared to placebo in treating migraine subjects who have previously discontinued treatment with short acting triptans (rizatriptan, sumatriptan, almotriptan, zolmitriptan, and eletriptan).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
169
Matching placebo tablet
Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in second layer.
GSK Investigational Site
Jasper, Alabama, United States
GSK Investigational Site
Oceanside, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Hartford, Connecticut, United States
GSK Investigational Site
Aventura, Florida, United States
Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose
Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.
Time frame: 2 - 24 Hours Post-Dose
Migraine Headache Pain Free at 2 Hours Post-Dose
Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.
Time frame: 2 Hours Post-Dose
Rescue Medication Use During 0 - 24 Hours Post-Dose
A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label).
Time frame: 0-24 Hours Post-Dose
Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose
Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.
Time frame: 0.5, 1, 4, and 8 Hours Post-Dose
Sustained Freedom From Migraine
Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication.
Time frame: 2 - 24 hours post-dose
Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose
Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment.
Time frame: 2, 4 , and 8 hours post-dose
Sustained Freedom From Migraine-Associated Sinus Pain
Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.
Time frame: 2 - 24 hours post-dose
Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who had sinus pain at the time of assessment.
Time frame: Baseline, 2, 4, and 8 hours post-dose
Sustained Freedom From Migraine-Associated Neck Pain
Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.
Time frame: 2 - 24 hours post-dose
Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of Participants with neck pain at the time of assessment.
Time frame: Baseline, 2, 4, and 8 hours post-dose
Sustained Freedom From Migraine-Associated Photophobia
Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.
Time frame: 2 - 24 hours post-dose
Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who had photophobia (sensitivity to light) at the time of assessment.
Time frame: Baseline, 2, 4, and 8 hours post-dose
Sustained Freedom From Migraine-Associated Phonophobia
Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.
Time frame: 2 - 24 hours post-dose
Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.
Time frame: Baseline, 2, 4, and 8 hours post-dose
Sustained Freedom From Migraine-Associated Nausea
Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.
Time frame: 2 - 24 hours post-dose
Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present.
Time frame: Baseline, 2, 4, and 8 hours
Sustained Complete Pain/Symptom-Free
Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication.
Time frame: 2 - 24 hours post-dose
Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment. "Complete pain/symptom-free" was defined as migraine-free, neck pain-free, and sinus pain free.
Time frame: Baseline, 2, 4, and 8 hours post-dose
Recurrence of Any Migraine Headache Pain
Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours.
Time frame: 24 hours and 48 hours
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GSK Investigational Site
Augusta, Georgia, United States
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