Official Title: “A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Eletriptan (Study 2 of 2)”

Studies have been done to evaluate the efficacy of several triptans in patients who do not respond to sumatriptan. This study is a new concept to evaluate the new Combination Product in patients who do not respond to eletriptan.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Combination Product (sumatriptan succinate / naproxen sodium)

Primary Measures

• Proportion of subjects with Sustained Pain Free between 2-24hrs post dose.

Secondary Measures

• a.pain-free; b.recurrence; c.absence of nausea, photophobia, and phonophobia; d.relief from neck pain; e.relief from sinus pain; f.rescue medication

Inclusion Criteria:

• Consented males and nonpregnant females using adequate contraception, between 18 and 65 years of age, with at least 1-8 migraines per month for past 3 months. Eligible subjects must have been discontinued from eletriptan treatment within the past year due to poor response and/or intolerance.

Exclusion Criteria:

• Subjects were excluded for confirmed or suspected ischemic heart disease, uncontrolled hypertension at screening; a history of epilepsy or structural brain lesions which lowered the convulsive threshold; confirmed or suspected cardiovascular, cerebrovascular, peripheral vascular, congenital heart disease, or ischemic bowel disease; impaired hepatic or renal function; basilar or hemiplegic migraine. Other exclusion criteria included use of a monoamine oxidase inhibitor within 2 weeks before screening; ergot prophylactics in past 3 months; anticoagulants; opioid narcotics in past 6 months, had evidence of alcohol or substance abuse; recent gastric bypass surgery or other GI bleeding disorders, inflammatory bowel disease; ACE inhibitors; or any concurrent medical or psychiatric condition that in the investigator’s opinion could affect interpretation of efficacy or safety information or which otherwise contraindicated participation in the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pozen

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Chair GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on August 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00382993

Study ID Number: TRX106573

ClinicalTrials.gov Identifier: NCT00382993

Health Authority: United States: Food and Drug Administration