Efficacy of Combination Product (Sumatriptan Succinate/Naproxen Sodium) in Eletriptan Non-Responders.

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...

Date First Received: September 29, 2006

Last Updated: June 4, 2007

Verified by: Pozen, June 2007

Clinical Trial Phase: Phase 4 | Start Date: October 2006

Overall Status: Recruiting

Estimated Enrollment: 167

Brief Summary

Official Title: “A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Eletriptan (Study 1 of 2)”

Condition Keyword(s):

Migraine

Intervention(s):

Drug: Combination Product (sumatriptan succinate / naproxen sodium)

Study Type: Interventional

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

Outcome Measures for this Clinical Trial

Primary:

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

Secondary:

Migraine with or without aura (ICHD-II Criteria 1.2 or 1.1).

Criteria for Participation in this Clinical Trial

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. 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.