A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: sumatriptan and naproxen sodium combination tablet; sumatriptan tablet; naproxen sodium tablet
Intervention description: sumatriptan 85mg and naproxen sodium 500mg; sumatriptan 85mg; Naproxen sodium 500mg
Intervention MeSH terms: Naproxen; Sumatriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: sumatriptan and naproxen sodium; migraine with or without aura; naproxen sodium; sumatriptan; blood pressure; migraine headaches

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects eligible for enrollment in the study must meet all of the following criteria:

          -  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.

          -  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.

          -  Subject is able to distinguish migraine attacks from other headaches (i.e.
             tension-type headaches).

          -  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:

          -  Subject has ≥10 migraine attacks or ≥15 headache days per month in total (including
             migraine, probable migraine or tension-type headache).

          -  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].

          -  Subject has a history of controlled or uncontrolled hypertension or is currently
             taking any angiotension-converting enzyme (ACE) inhibitor or angiotension receptor
             blocker.

          -  Subject has an in-clinic screening blood pressure of ≥ 130/85 mmHg in two out of three
             blood pressure measurements.

          -  Subject is taking any anti-hypertensive medication for any reason including for
             migraine prophylaxis.

          -  Subject has a glycosylated hemoglobin ≥ 8.0

          -  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.

          -  Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular
             or cerebrovascular disease.

          -  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.

          -  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.

          -  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.

          -  Subject has a history of impaired hepatic or renal function that, in the
             investigator's opinion, contraindicates participation in the 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 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.

          -  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.

          -  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.

          -  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).

          -  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.

          -  Subject is pregnant, actively trying to become pregnant, or breast feeding or subject
             is not willing to have pregnancy tests performed as required.

          -  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.

          -  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.