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NCT00792636

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

Last Updated: 2016-11-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine Disorders

Keywords

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sumatriptan and naproxen sodium migraine with or without aura naproxen sodium sumatriptan blood pressure migraine headaches

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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sumatriptan and naproxen sodium combination

Group Type EXPERIMENTAL

sumatriptan and naproxen sodium combination tablet

Intervention Type DRUG

sumatriptan 85mg and naproxen sodium 500mg

sumatriptan

Group Type ACTIVE_COMPARATOR

sumatriptan tablet

Intervention Type DRUG

sumatriptan 85mg

naproxen sodium

Group Type ACTIVE_COMPARATOR

naproxen sodium tablet

Intervention Type DRUG

Naproxen sodium 500mg

Interventions

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sumatriptan and naproxen sodium combination tablet

sumatriptan 85mg and naproxen sodium 500mg

Intervention Type DRUG

sumatriptan tablet

sumatriptan 85mg

Intervention Type DRUG

naproxen sodium tablet

Naproxen sodium 500mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Explore related publications, articles, or registry entries linked to this study.

White WB, Derosier FJ, Thompson AH, Adams BE, Goodman DK. Evaluation of the migraine treatment sumatriptan/naproxen sodium on blood pressure following long-term administration. J Clin Hypertens (Greenwich). 2011 Dec;13(12):910-6. doi: 10.1111/j.1751-7176.2011.00554.x. Epub 2011 Nov 11.

Reference Type BACKGROUND

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

sumatriptan and naproxen sodium combination

sumatriptan and naproxen sodium combination tablet

sumatriptan

sumatriptan tablet

naproxen sodium

naproxen sodium tablet

Interventions

sumatriptan and naproxen sodium combination tablet

sumatriptan tablet

naproxen sodium tablet

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

GlaxoSmithKline

Responsible Party

Principal Investigators

GSK Clinical Trials

Locations

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Countries

References

White WB, Derosier FJ, Thompson AH, Adams BE, Goodman DK. Evaluation of the migraine treatment sumatriptan/naproxen sodium on blood pressure following long-term administration. J Clin Hypertens (Greenwich). 2011 Dec;13(12):910-6. doi: 10.1111/j.1751-7176.2011.00554.x. Epub 2011 Nov 11.