The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen
sodium combination tablets, tablets containing only sumatriptan, and tablets containing only
naproxen sodium when these drugs are taken to treat migraine headaches that occur during a
6-month period.
Inclusion Criteria:
Subjects eligible for enrollment in the study must meet all of the following criteria:
1. Male and female outpatients 18 to 65 years of age. Female subjects are eligible for
participation in the study if they are:
- Females of non-childbearing potential
- Females of childbearing potential and who have a negative urine pregnancy test at
Screening and agree to use one of the GlaxoSmithKline specified highly
effective methods for avoiding pregnancy. Subjects taking oral contraceptives
must be on a stable regimen for at least two months prior to Screening.
2. Subject with migraines, with or without aura (ICHD-II criteria, 1. 2.1 or 1. 1)
[International Headache Society, 2004]. Subject must have a history of two to eight
attacks per month, on average, for the six months prior to the Screening Visit.
Additionally the subject is to have experienced at least two, but no more than eight,
migraine attacks per month for the three months prior to Screening Visit.
3. Subject is able to distinguish migraine attacks from other headaches (i. e.
tension-type headaches).
4. Subject is willing and able to provide written informed consent, to comprehend and
perform the requirements of the protocol.
Exclusion criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
1. Subject has ≥10 migraine attacks or ≥15 headache days per month in total (including
migraine, probable migraine or tension-type headache).
2. Subject has retinal (ICHD-II 1. 4), basilar (ICHD-II 1. 2.6), or hemiplegic migraine
(ICHD-II 1. 2.4), or secondary headaches [International Headache Society, 2004].
3. Subject has a history of controlled or uncontrolled hypertension or is currently
taking any angiotension-converting enzyme (ACE) inhibitor or angiotension receptor
blocker.
4. Subject has an in-clinic screening blood pressure of ≥ 130/85 mmHg in two out of three
blood pressure measurements.
5. Subject is taking any anti-hypertensive medication for any reason including for
migraine prophylaxis.
6. Subject has a glycosylated hemoglobin ≥ 8. 0
7. Subject has a chronic condition (i. e. osteoarthritis, rheumatoid
arthritis,fibromyalgia) which requires chronic daily administration of non-steroidal
anti-inflammatory drugs (NSAIDS) (including acetaminophen) or opioids or opioid
combination products.
8. Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular
or cerebrovascular disease.
9. 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 the study.
10. 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 any signs or symptoms consistent with any of the above.
11. 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 five years prior to Screening.
12. Subject has a history of impaired hepatic or renal function that, in the
investigator's opinion, contraindicates participation in the study.
13. 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.
14. Subject is currently taking, or has used, an ergot or ergot-derived medication in the
previous three months for migraine prophylaxis or is taking a medication that is not
stabilized (i. e. change of a dose within the past two months) for chronic or
intermittent migraine prophylaxis or for a co-morbid condition that is not
stabilized.
15. Subject has a recent history of regular use of opioids or barbiturates for the
treatment of their migraine headache and/or other non-migraine pain. Regular use is
defined as an average of four days per month over the last six months.
16. Subject has taken or plans to take a monoamine oxidase inhibitor (MAOI), including
herbal preparations containing St. John's Wort (Hypericum perforatum) or a CNS
stimulant medication (such as atomoxetine, dextroamphetamine and amephetamine
products, dexmethlyphenidate, lisdexamdetamine dimesylate and methylphenidate) anytime
within two weeks prior to Screening through two-weeks post-treatment.
17. Subject has a history of any bleeding disorder or is currently taking any
anticoagulant or any anti-platelet agent. (except low-dose aspirin <=325mg/day for
cardioprotective reasons).
18. Subject has evidence or history of any gastrointestinal surgery, gastrointestinal
ulceration or perforation in the past six months, gastrointestinal bleeding in the
past year, or evidence or history of inflammatory bowel disease.
19. Subject is pregnant, actively trying to become pregnant, or breast feeding or subject
is not willing to have pregnancy tests performed as required.
20. 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.
21. Subject has participated in an investigational drug trial within the previous four
weeks or plans to participate in another study at any time during the study.
GSK Investigational Site, Phoenix, Arizona 85014, United States
GSK Investigational Site, Litchfield Park, Arizona 85340, United States
GSK Investigational Site, Chandler, Arizona 85224, United States
GSK Investigational Site, Tempe, Arizona 85282, United States
GSK Investigational Site, Phoenix, Arizona 85050, United States
GSK Investigational Site, Gilbert, Arizona 85234, United States
GSK Investigational Site, Little Rock, Arkansas 72205, United States
GSK Investigational Site, Anaheim, California 92805, United States
GSK Investigational Site, Newport Beach, California 92660, United States
GSK Investigational Site, Westlake Village, California 91361, United States
GSK Investigational Site, Anaheim, California 92801, United States
GSK Investigational Site, Santa Monica, California 90404, United States
GSK Investigational Site, Fresno, California 93726, United States
GSK Investigational Site, Garden Grove, California 92845, United States
GSK Investigational Site, Denver, Colorado 80239, United States
GSK Investigational Site, Colorado Springs, Colorado 80904, United States
GSK Investigational Site, Avon, Connecticut 06001, United States
GSK Investigational Site, Pembroke Pines, Florida 33024, United States
GSK Investigational Site, St. Petersburg, Florida 33702, United States
GSK Investigational Site, Sunrise, Florida 33351, United States
GSK Investigational Site, Hialeah, Florida 33013, United States
GSK Investigational Site, Miami, Florida 33143, United States
GSK Investigational Site, Jacksonville, Florida 32216, United States
GSK Investigational Site, Atlanta, Georgia 30308, United States
GSK Investigational Site, Decatur, Georgia 30034, United States
GSK Investigational Site, Chicago, Illinois 60614, United States
GSK Investigational Site, Wichita, Kansas 67207, United States
GSK Investigational Site, Milford, Massachusetts 01757, United States
GSK Investigational Site, Kalamazoo, Michigan 49009, United States
GSK Investigational Site, St. Louis, Missouri 63141, United States
GSK Investigational Site, Springfield, Missouri 65804, United States
GSK Investigational Site, Raleigh, North Carolina 27607, United States
GSK Investigational Site, Greensboro, North Carolina 27405, United States
GSK Investigational Site, Raleigh, North Carolina 27609, United States
GSK Investigational Site, Matthews, North Carolina 28105, United States
GSK Investigational Site, Raleigh, North Carolina 27612, United States
GSK Investigational Site, Winston-Salem, North Carolina 27103, United States
GSK Investigational Site, Westerville, Ohio 43081, United States
GSK Investigational Site, Cleveland, Ohio 44122, United States
GSK Investigational Site, West Chester, Ohio 45069, United States
GSK Investigational Site, Oklahoma City, Oklahoma 73112, United States
GSK Investigational Site, Pittsburgh, Pennsylvania 15236, United States
GSK Investigational Site, Simpsonville, South Carolina 29681, United States
GSK Investigational Site, Mount Pleasant, South Carolina 29464, United States
GSK Investigational Site, Bristol, Tennessee 37620, United States
GSK Investigational Site, Nashville, Tennessee 37203, United States
GSK Investigational Site, Memphis, Tennessee 38018, United States
GSK Investigational Site, Austin, Texas 78705, United States
GSK Investigational Site, San Antonio, Texas 78229, United States
GSK Investigational Site, Houston, Texas 77004, United States
GSK Investigational Site, West Jordan, Utah 84088, United States
GSK Investigational Site, Salt Lake City, Utah 84107, United States
GSK Investigational Site, Alexandria, Virginia 22311, United States
