Treximet clinical trials

Adult healthy subjects between 18 to 55 years old inclusive at the screening visit. Subject BMI and weight must fall between the following: Adolescent subject body weight less than A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.

For younger adolescent migraine subjects, non-childbearing potential also defined as premenarchal is a young female who has not yet entered puberty as evidenced by lack of breast development of palpable glandular breast tissue. Females on hormone replacement therapy and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.

For most forms of HRT, at least weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.

Female subjects who are sexually active must agree to use contraception until 5 day after dosing. Subjects must be able to read and write English or Spanish and give written informed consent as follows: Adult: subject is willing and able to provide written informed consent Adolescent: subject is capable of giving written assent with an informed consent from their parents or legal guardian, which includes compliance with the requirements and restrictions listed in the consent form.

Subject is experiencing a migraine attack or has experienced a migraine attack within 24 hours of dosing. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening A positive test for HIV antibody. 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.

Subject has a history of impaired hepatic or renal function 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 taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a medication that is not stabilized i.

Regular use is defined as an average of 4 days per month over the last 6 months. Subject has taken, or plans to take, a monoamine oxidase inhibitor, or herbal preparations containing St. John's Wort Hypericum perforatum , anytime within the 2 weeks prior to screening through 2 weeks post final study treatment. Subject history of any bleeding disorder or is currently taking any anti-coagulant or any anti-platelet agent. Subject is pregnant, actively trying to become pregnant, or breast feeding or subject not willing to have pregnancy test performed at each study visit.

Sexually active female subjects using inadequate contraceptive measures i. Subject has participated in an investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study. Drug Information available for: Naproxen Naproxen sodium. FDA Resources. Arms and Interventions. This is another of the five treatment arms. Approximately one fifth of the subjects will be randomized to this group and treat their first migraine with Active Treximet and the second migraines with Placebo.

One fifth of the subjects will be randomized to this treatment arm, where they will treat the first headache with placebo and the remaining three migraines will be treated with Active treximet. One fifth of the subject will treat all their migraines with Active Treximet.

Outcome Measures. All data was collected and measured from self-reported patient diaries. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Male or female subjects between the ages of A history of at least 1 but no more than 8 attacks per month on average over the past 6 months prior to screening visit.

Attacks should be moderate to severe and last for at least 3 hours. Female subjects are eligible for participation provided they are of non-child bearing potential or if started menses; they are on a stable regimen of approved contraception. Subject and subject's parent or legal guardian are able to read and write English. Subject is able to read, comprehend, and complete subject diaries.

Subjects' parent or legal guardian is willing and able to provide Informed Consent prior to subject entry into the study. Subject is willing and able to provide Informed Assent prior to entry into the study. Subject has secondary headaches i. Subject, in investigators opinion is likely to have unrecognized cardiovascular or cerebrovascular disease. Subject has uncontrolled hypertension at screening or is taking an angiotensin-converting enzyme ACE inhibitor or angiotensin receptor blocker.

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. It can be administered orally, intranasally or by subcutaneous injection, and is considered preferred therapy for migraine patients who are refractory to simple analgesics. Triptans are believed to induce vasoconstriction of the cartoid arterial circulation, which dilates during a migraine attack.

In addition, they may act at synapses of the trigeminal nerve to reduce neuronal firing and inhibit release of neurotransmitters that cause vasodilation.

They are effective against not only headache but also associated symptoms of nausea, photophobia and phonophobia. Triptans are contraindicated in patients with ischaemic heart disease and unstable angina. They should not be given concomitantly with ergotamine, a drug also used in the treatment of migraine.

Triptans, described above, and non-steroidal anti-inflammatory drugs NSAIDs are both widely used in the treatment of acute migraine for the relief of pain and other symptoms. Combining a triptan and NSAID in a single tablet has the potential to provide greater symptom relief than therapy with either drug alone.

In addition to Revised Patient Perception of Migraine Questionnaire PPMQ-R data, a detailed diary will be recorded regarding number of tablets taken per attack, compliance, rescue treatment, when patients treated their migraine attack mild, moderate, or severe , onset of pain reduction pain relief and pain free, and 24 hour pain relief and sustained pain free response.

Detailed Description:. MedlinePlus related topics: Headache Migraine. FDA Resources. Arms and Interventions. Imitrex tablet, one tablet dose, Aleve tablets, 2 mg tablet dose.

Second dose of tablets may be taken if migraine persists for two hours. Outcome Measures. Secondary Outcome Measures : Measurement of time to onset of pain relief [ Time Frame: One year ] Measurement of time to onset of pain free [ Time Frame: one year ] Measurement of 24 hour sustained pain free [ Time Frame: One year ] Measurement of 24 hour sustained pain relief [ Time Frame: One year ].

Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: A subject will be eligible for inclusion in this study if all of the following criteria apply: Subject is male or female.

Subject is age 18 to A female is eligible to enter and participate in this study if she is not breast feeding and is of: non-childbearing potential i.

Subject is able to read, understand and complete diaries, subject questionnaires and the instructions for the study. Subject is able and willing to give written informed consent to participate in the study. Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome. Subject has cardiac arrhythmias requiring medication or a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.

Subject has a history of cerebrovascular pathology including stroke. Subject has a history of congenital heart disease. Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease. Subject has significant peripheral vascular disease Subject is currently taking any anti-coagulant e. Subject has a history of inflammatory bowel disease.