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
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
1 other identifier
interventional
407
1 country
49
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2008
Shorter than P25 for phase_4
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 17, 2008
CompletedFirst Posted
Study publicly available on registry
November 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
November 4, 2010
CompletedNovember 23, 2016
October 1, 2016
1 year
November 17, 2008
October 7, 2010
October 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen
The calculation of baseline and post-baseline mean blood pressure (BP) (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).
Baseline and Month 6
Secondary Outcomes (14)
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen
Baseline and Month 6
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan
Baseline and Month 6
Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen
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
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
Baseline and Month 6
- +9 more secondary outcomes
Study Arms (3)
sumatriptan and naproxen sodium combination
EXPERIMENTALsumatriptan
ACTIVE COMPARATORnaproxen sodium
ACTIVE COMPARATORInterventions
sumatriptan 85mg and naproxen sodium 500mg
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (49)
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
St. Petersburg, Florida, 33702, 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
Matthews, North Carolina, 28105, 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
Mt. 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
Related Publications (1)
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.
PMID: 22142350BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2008
First Posted
November 18, 2008
Study Start
November 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
November 23, 2016
Results First Posted
November 4, 2010
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.