Last updated: 11/07/2018 03:10:12
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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline in systolic and diastolic blood pressure at Month 6 for sumatriptan/naproxen
Timeframe: Baseline and Month 6
Secondary outcomes:
Mean change from baseline in systolic and diastolic blood pressure at Month 6 for sumatriptan and naproxen
Timeframe: Baseline and Month 6
Treatment difference in systolic and diastolic blood pressure mean changes from baseline at 6 months between sumatriptan/naproxen and sumatriptan
Timeframe: Baseline and Month 6
Treatment difference in systolic and diastolic blood pressure mean changes from baseline at 6 months between sumatriptan/naproxen and naproxen
Timeframe: Baseline and Month 6
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
Timeframe: Baseline and Month 6
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
Timeframe: Baseline and Month 6
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
Timeframe: Baseline and Month 6
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
Timeframe: Baseline and Month 6
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
Timeframe: Baseline to End of Study (6-month study duration)
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
Timeframe: Baseline to End of Study (6-month study duration)
Number of participants with a consecutive 2-day average systolic blood pressure of >=140 mmHg during the study
Timeframe: Baseline to End of Study (6-month study duration)
Number of participants with a consecutive 2-day average diastolic blood pressure of >=90 mmHg
Timeframe: Baseline to End of Study (6-month study duration)
Time to the first day with an average systolic blood pressure increase of >=5 mmHg from the baseline systolic blood pressure
Timeframe: Baseline to End of Study (6-month study duration)
Time to the first day with an average diastolic blood pressure increase of >=3 mmHg from the baseline diastolic blood pressure
Timeframe: Baseline to End of Study (6-month study duration)
Number of participants withdrawn from the study due to blood pressure changes
Timeframe: Baseline to End of Study (6-month study duration)
Interventions:
Enrollment:
407
Primary completion date:
2009-02-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
William B White, MD; Frederick J Derosier, DO; April H Thompson, MA; Bryan E Adams, PhD; David K Goodman, BS . Evaluation of the Migraine Treatment Sumatriptan/Naproxen Sodium on Blood Pressure Following Long-Term Administration . J Clin Hypertens (Greenwich). 2011;13(12):910-916.
Medical condition
Migraine Disorders
Product
naproxen, sumatriptan, sumatriptan/naproxen
Collaborators
Not applicable
Study date(s)
November 2008 to November 2009
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- 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
- 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).
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects eligible for enrollment in the study must meet all of the following criteria:
- 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.
Male and female outpatients 18 to 65 years of age. Female subjects are eligible for participation in the study if they are:
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.
Trial location(s)
Location
GSK Investigational Site
Sunrise, Florida, United States, 33351
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38018
Status
Study Complete
Location
GSK Investigational Site
Gilbert, Arizona, United States, 85234
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Study Complete
Location
GSK Investigational Site
Litchfield Park, Arizona, United States, 85340
Status
Study Complete
Location
GSK Investigational Site
West Jordan, Utah, United States, 84088
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33702
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60614
Status
Study Complete
Location
GSK Investigational Site
Harrisburg, North Carolina, United States, 28075
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92660
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Westlake Village, California, United States, 91361
Status
Study Complete
Location
GSK Investigational Site
Garden Grove, California, United States, 92845
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Chester, Ohio, United States, 45069
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80904
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Matthews, North Carolina, United States, 28105
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Anaheim, California, United States, 92805
Status
Study Complete
Location
GSK Investigational Site
Buena Park, California, United States, 90620
Status
Study Complete
Location
GSK Investigational Site
Decatur, Georgia, United States, 30034
Status
Study Complete
Location
GSK Investigational Site
Springfield, Missouri, United States, 65807
Status
Study Complete
Location
GSK Investigational Site
Hialeah, Florida, United States, 33010
Status
Study Complete
Location
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78205
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27405
Status
Study Complete
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44122
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Avon, Connecticut, United States, 06001
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2009-02-11
Actual study completion date
2009-02-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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