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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

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ClinicalTrials.gov Identifier: NCT00792636
Recruitment Status : Completed
First Posted : November 18, 2008
Results First Posted : November 4, 2010
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE November 17, 2008
First Posted Date  ICMJE November 18, 2008
Results First Submitted Date  ICMJE October 7, 2010
Results First Posted Date  ICMJE November 4, 2010
Last Update Posted Date November 23, 2016
Study Start Date  ICMJE November 2008
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2010)
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen [ Time Frame: Baseline and Month 6 ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2008)
Systolic and diastolic blood pressure measured at home using telephonic self-measured blood pressure [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT00792636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2011)
  • Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen [ Time Frame: Baseline and Month 6 ]
    The calculation of baseline and post-baseline mean 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).
  • Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan [ Time Frame: Baseline and Month 6 ]
    The calculation of baseline and post-baseline mean 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).
  • Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen [ Time Frame: Baseline and Month 6 ]
    The calculation of baseline and post-baseline mean 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).
  • 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 [ Time Frame: Baseline and Month 6 ]
    The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. LSMeans and corresponding confidence intervals were not calculated for > 6 migraines/month group due to lack of convergence.
  • 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 [ Time Frame: Baseline and Month 6 ]
    The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis.
  • 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 [ Time Frame: Baseline and Month 6 ]
    The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 10-14 and the >14 doses/month groups due to lack of convergence.
  • 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 [ Time Frame: Baseline and Month 6 ]
    The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 60-90 and the >90 total dose groups due to lack of convergence.
  • 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 [ Time Frame: Baseline to End of Study (6-month study duration) ]
    The 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 valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
  • 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 [ Time Frame: Baseline to End of Study (6-month study duration) ]
    The 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 valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
  • Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study [ Time Frame: Baseline to End of Study (6-month study duration) ]
    The number of participants with any valid two-day consecutive average systolic blood pressure measurement of >=140 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
  • Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg [ Time Frame: Baseline to End of Study (6-month study duration) ]
    The number of participants with any valid two-day consecutive average diastolic blood pressure measurement of >=90 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
  • Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure [ Time Frame: Baseline to End of Study (6-month study duration) ]
    Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
  • Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure [ Time Frame: Baseline to End of Study (6-month study duration) ]
    Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
  • Number of Participants Withdrawn From the Study Due to Blood Pressure Changes [ Time Frame: Baseline to End of Study (6-month study duration) ]
    The number of participants withdrawn from the study due to protocol-defined blood pressure changes were summarized for each treatment group. Defined blood pressure changes included (1) monthly average BP ≥140 mmHg systolic or >=90 mmHg diastolic and confirmed in clinic, (2) monthly average BP increase of >=30 mmHg systolic or >=20 mmHg from in-clinic screening and confirmed in clinic, and (3) systolic >=140 mmHg or diastolic >=90 mmHg on consecutive clinic visits >=2 weeks apart.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2008)
  • Systolic and diastolic blood pressure measured at home using telephonic self-measured blood pressure [ Time Frame: time to event ]
  • Subjects withdrawn from the study due to blood pressure changes [ Time Frame: any time after treatment ]
  • Systolic and diastolic blood pressure measured at home using telephonic self-measured blood pressure [ Time Frame: any given 2-day scheduled block of blood pressure measurements during the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine Disorders
Intervention  ICMJE
  • Drug: sumatriptan and naproxen sodium combination tablet
    sumatriptan 85mg and naproxen sodium 500mg
  • Drug: sumatriptan tablet
    sumatriptan 85mg
  • Drug: naproxen sodium tablet
    Naproxen sodium 500mg
Study Arms  ICMJE
  • Experimental: sumatriptan and naproxen sodium combination
    Intervention: Drug: sumatriptan and naproxen sodium combination tablet
  • Active Comparator: sumatriptan
    Intervention: Drug: sumatriptan tablet
  • Active Comparator: naproxen sodium
    Intervention: Drug: naproxen sodium tablet
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2010)
407
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2008)
420
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00792636
Other Study ID Numbers  ICMJE 110948
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP