A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2)
1 other identifier
interventional
169
1 country
28
Brief Summary
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). \[Study 2 of 2\]
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2006
Shorter than P25 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2006
CompletedFirst Posted
Study publicly available on registry
October 2, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
April 20, 2010
CompletedFebruary 2, 2017
December 1, 2016
11 months
September 29, 2006
November 14, 2008
December 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose
Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.
2 - 24 Hours Post-Dose
Secondary Outcomes (18)
Migraine Headache Pain Free at 2 Hours Post-Dose
2 Hours Post-Dose
Rescue Medication Use During 0 - 24 Hours Post-Dose
0-24 Hours Post-Dose
Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose
0.5, 1, 4, and 8 Hours Post-Dose
Sustained Freedom From Migraine
2 - 24 hours post-dose
Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose
2, 4 , and 8 hours post-dose
- +13 more secondary outcomes
Study Arms (2)
Combination Product - Placebo
OTHERCombination Product (sumatriptan and naproxen sodium) \[Attack 1\] followed by Placebo \[Attack 2\]
Placebo - Combination Product
OTHERPlacebo \[Attack 1\] followed by Combination Product (sumatriptan and naproxen sodium) \[Attack 2\]
Interventions
Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in second layer.
Eligibility Criteria
You may qualify if:
- Subject is male or female between 18 and 65 years old.
- Subject has migraine with or without aura (2004 ICHD-II criteria).
- Subject has 1-8 migraines per month over the previous 3 months and less than 15 total headache days per month.
- Subject has recently (within 1 year) discontinued the use of eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan, due to nonresponse or intolerable adverse events. Non-response is defined as documented discontinuation of treatment with eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan for reasons related to response, including (but not limited to): slow onset of efficacy, inconsistent efficacy, inadequate overall efficacy, or inadequate sustained efficacy through 24 hours. Intolerance is defined as documented discontinuation of treatment with eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan for other reasons, attributable to the triptan, outside of non-response.
- A female is eligible to enter and participate in this study if she is of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
- child-bearing potential, has a negative urine pregnancy test at screen, and agrees to one of the following acceptable measures of contraception:
- Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 5 days); subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit; or,
- Female sterilization; or,
- Sterilization of male partner; or,
- Implants of levonorgestrel; or,
- Injectable progestogen; or,
- Oral contraceptive (combined or progestogen only); or,
- Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or,
- Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm); or,
- +5 more criteria
You may not qualify if:
- Subject has non-migraine headache, retinal migraine, basilar or hemiplegic migraine, cluster headache, or headaches secondary to trauma, cranial or cervical disorders, infections, alterations of homeostasis, ENT disorders, psychiatric disorders or cranial neuralgias.
- Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm, or signs/symptoms consistent with any of the above.
- Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome.
- Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
- Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs).
- Subject has a history of congenital heart disease.
- Subject has uncontrolled hypertension at screening (sitting systolic pressure ≥140mmHg, diastolic pressure ≥90mmHg).
- Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or the presence of risk factors including but not limited to, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age).
- Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening.
- Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
- Subject is currently taking a monoamine oxidase inhibitor (MAOI), or has taken a MAOI within 2 weeks prior to screening or plans to take within 2 weeks after treatment.
- Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a medication that is not stabilized (i.e. change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized..
- Subject is currently taking any anti-coagulant (e.g., warfarin).
- Subject has a recent history of regular use of opioids or barbiturates for treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months.
- Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John's Wort (Hypericum perforatum).
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (28)
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Oceanside, California, 92056, United States
GSK Investigational Site
San Francisco, California, 94109, United States
GSK Investigational Site
Hartford, Connecticut, 06106, United States
GSK Investigational Site
Aventura, Florida, 33180, United States
GSK Investigational Site
Augusta, Georgia, 30901, United States
GSK Investigational Site
Savannah, Georgia, 31405, United States
GSK Investigational Site
Northbrook, Illinois, 60062, United States
GSK Investigational Site
Des Moines, Iowa, 50314, United States
GSK Investigational Site
Shreveport, Louisiana, 71103, United States
GSK Investigational Site
Pikesville, Maryland, 21208, United States
GSK Investigational Site
Boston, Massachusetts, 02215, United States
GSK Investigational Site
Worcester, Massachusetts, 01605, United States
GSK Investigational Site
Ann Arbor, Michigan, 48104, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Omaha, Nebraska, 68114, United States
GSK Investigational Site
Stratford, New Jersey, 08084, United States
GSK Investigational Site
Williamsville, New York, 14221, United States
GSK Investigational Site
Toledo, Ohio, 43614-5809, United States
GSK Investigational Site
Westerville, Ohio, 43081, United States
GSK Investigational Site
Allentown, Pennsylvania, 18103, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Charleston, South Carolina, 29412, United States
GSK Investigational Site
Memphis, Tennessee, 38018, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
Related Publications (2)
Mathew N, Landy S, Tietjen G, Stark S, Runken M, Lener S, Derosier F, and Bukenya D. Evaluation of a single fixed-dose tablet of Sumatriptan 85 mg formulated with RT Technology/Naproxen sodium 500 mg (SumaRT/Nap) in Subjects who Reported Poor Response or Intolerance to Short Acting Triptans for the Acute Treatment of Migraine. Headache 2008: S44-45.
BACKGROUNDMathew NT, Landy S, Stark S, Tietjen GE, Derosier FJ, White J, Lener SE, Bukenya D. Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache. 2009 Jul;49(7):971-82. doi: 10.1111/j.1526-4610.2009.01458.x. Epub 2009 May 27.
PMID: 19486178BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- Glaxo Smith Kline
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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2006
First Posted
October 2, 2006
Study Start
December 1, 2006
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
February 2, 2017
Results First Posted
April 20, 2010
Record last verified: 2016-12
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.