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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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine With or Without Aura; Migraine Disorders; Migraine, Acute; Migraine Headaches

Intervention: sumatriptan and naproxen sodium combination tablet (Drug); sumatriptan tablet (Drug); naproxen sodium tablet (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: Assessment of the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet Treatment on Blood Pressure When Administered Intermittently for Six Months for the Acute Treatment of Migraine Attacks, With or Without Aura, in Adults

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen

Secondary outcome:

Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen

Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan

Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen

Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month

Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine

Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month

Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses

Number of Participants With an Increase of >=5 mmHg From the Baseline Systolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements

Number of Participants With an Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements

Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study

Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg

Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure

Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure

Number of Participants Withdrawn From the Study Due to Blood Pressure Changes

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Chandler, Arizona 85224, United States

GSK Investigational Site, Gilbert, Arizona 85234, United States

GSK Investigational Site, Litchfield Park, Arizona 85340, United States

GSK Investigational Site, Phoenix, Arizona 85050, United States

GSK Investigational Site, Tempe, Arizona 85283, United States

GSK Investigational Site, Little Rock, Arkansas 72205, United States

GSK Investigational Site, Anaheim, California 92801, United States

GSK Investigational Site, Anaheim, California 92805, United States

GSK Investigational Site, Buena Park, California 90620, United States

GSK Investigational Site, Garden Grove, California 92845, United States

GSK Investigational Site, Newport Beach, California 92660, United States

GSK Investigational Site, Santa Monica, California 90404, United States

GSK Investigational Site, Westlake Village, California 91361, United States

GSK Investigational Site, Colorado Springs, Colorado 80904, United States

GSK Investigational Site, Avon, Connecticut 06001, United States

GSK Investigational Site, Hialeah, Florida 33010, United States

GSK Investigational Site, Jacksonville, Florida 32216, United States

GSK Investigational Site, Miami, Florida 33143, United States

GSK Investigational Site, Pembroke Pines, Florida 33024, United States

GSK Investigational Site, Sunrise, Florida 33351, 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, Kalamazoo, Michigan 49009, United States

GSK Investigational Site, Springfield, Missouri 65807, United States

GSK Investigational Site, St. Louis, Missouri 63141, United States

GSK Investigational Site, Greensboro, North Carolina 27405, United States

GSK Investigational Site, Harrisburg, North Carolina 28075, United States

GSK Investigational Site, Raleigh, North Carolina 27607, United States

GSK Investigational Site, Raleigh, North Carolina 27609, United States

GSK Investigational Site, Raleigh, North Carolina 27612, United States

GSK Investigational Site, Winston-Salem, North Carolina 27103, 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, Mount Pleasant, South Carolina 29464, United States

GSK Investigational Site, Simpsonville, South Carolina 29681, United States

GSK Investigational Site, Bristol, Tennessee 37620, United States

GSK Investigational Site, Memphis, Tennessee 38018, United States

GSK Investigational Site, Nashville, Tennessee 37203, United States

GSK Investigational Site, Austin, Texas 78705, United States

GSK Investigational Site, Houston, Texas 77004, United States

GSK Investigational Site, San Antonio, Texas 78205, United States

GSK Investigational Site, Salt Lake City, Utah 84107, United States

GSK Investigational Site, West Jordan, Utah 84088, United States

Additional Information

Related publications:

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.

Starting date: November 2008
Last updated: July 26, 2012

Page last updated: August 23, 2015

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