A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2)

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine Disorders

In brief

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). \[Study 1 of 2\]

Key facts

Study ID: NCT00383162
Run by: GlaxoSmithKline
People needed: 173
Starts: 2006-11-01
Expected to finish: 2007-10-01
Last updated by the study team: 2017-02-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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,
Any other methods with published data showing that the highest expected failure rate for that method is less than 1% per year; or,
Any other barrier methods only if used in combination with any of the above acceptable methods.
Subject taking oral contraceptives has been on a stable regimen for at least 2 months prior to screening.
Subject is willing and able to provide informed consent prior to entry into this treatment phase of the study.
Subject is able to understand and complete the diary card.
Exclusion Criteria: Subjects with any of the following criteria may not enroll in the study:
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.

Where it is running

GSK Investigational Site — Fresno, California, United States
GSK Investigational Site — Newport Beach, California, United States
GSK Investigational Site — Santa Monica, California, United States
GSK Investigational Site — Walnut Creek, California, United States
GSK Investigational Site — Fairfield, Connecticut, United States
GSK Investigational Site — Stamford, Connecticut, United States
GSK Investigational Site — Aventura, Florida, United States
GSK Investigational Site — Tallahassee, Florida, United States
GSK Investigational Site — Tampa, Florida, United States
GSK Investigational Site — Chicago, Illinois, United States
GSK Investigational Site — Northbrook, Illinois, United States
GSK Investigational Site — South Bend, Indiana, United States
GSK Investigational Site — Lenexa, Kansas, United States
GSK Investigational Site — St Louis, Missouri, United States
GSK Investigational Site — Omaha, Nebraska, United States
GSK Investigational Site — Orchard Park, New York, United States
GSK Investigational Site — Greensboro, North Carolina, United States
GSK Investigational Site — Matthews, North Carolina, United States
GSK Investigational Site — Raleigh, North Carolina, United States
GSK Investigational Site — Tabor City, North Carolina, United States
GSK Investigational Site — Fargo, North Dakota, United States
GSK Investigational Site — Dallas, Texas, United States
GSK Investigational Site — Houston, Texas, United States
GSK Investigational Site — Alexandria, Virginia, United States
GSK Investigational Site — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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