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

Condition(s) targeted: Migraine

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

Phase: Phase 4

Status: Recruiting

Sponsored by: Pozen

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: GlaxoSmithKline

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.

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)

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

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

Secondary outcome: 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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

GSK Clinical Trials Call Center, Jasper, Alabama, United States; Recruiting
Jan Westerman, MD, Phone: 205-387-7555

GSK Clinical Trials Call Center, Oceanside, California 92056, United States; Recruiting
Jack Schim, Phone: 760-732-0557

GSK Clinical Trials Call Center, San Francisco, California 94109, United States; Recruiting
Jerome Goldstein, Phone: 415-673-4600

GSK Clinical Trials Call Center, Hartford, Connecticut 06106, United States; Recruiting
Tanya Bilchik, Phone: 860-545-3416

GSK Clinical Trials Call Center, Augusta, Georgia 30901, United States; Recruiting
Marc Husid, Phone: 706-823-5211

GSK Clinical Trials Call Center, Savannah, Georgia 31405, United States; Withdrawn

GSK Clinical Trials Call Center, Northbrook, Illinois 60062, United States; Recruiting
Larry Robbins, Phone: 847-480-9399

GSK Clinical Trials Call Center, DesMoines, Iowa 50314, United States; Recruiting
Mark Puricelli, Phone: 515-358-0223

GSK Clinical Trials Call Center, Shreveport, Louisiana 71103, United States; Recruiting
Debra Elliott, Phone: 318-813-1481

GSK Clinical Trials Call Center, Pikesville, Maryland 21206, United States; Recruiting
Marcia Ribeiro, Phone: 410-602-1999

GSK Clinical Trials Call Center, Worcester, Massachusetts 01605, United States; Withdrawn

GSK Clinical Trials Call Center, Boston, Massachusetts 02215, United States; Not yet recruiting
Zahid Bajwa, Phone: 617-667-5739

GSK Clinical Trials Call Center, Ann Arbor, Michigan, United States; Recruiting
Todd Rozen, MD, Phone: 734-677-6000

GSK Clinical Trials Call Center, St Louis, Missouri 63141, United States; Not yet recruiting
Timothy Smith

GSK Clinical Trials Call Center, Saint Louis, Missouri 314-251-8890, United States; Recruiting
James Banks, MD, Phone: 314-251-8890

GSK Clinical Trials Call Center, Omaha, Nebraska 68114, United States; Recruiting
Jan Golnick, Phone: 402-926-4200

GSK Clinical Trials Call Center, Moorestown, New Jersey 08057, United States; Recruiting
Loretta Mueller, Phone: 856-566-6003

GSK Clinical Trials Call Center, Westerville, Ohio 43081, United States; Recruiting
Francis O'Donnell, Phone: 614-839-3254

GSK Clinical Trials Call Center, Toledo, Ohio 43614, United States; Recruiting
Gretchen Tietjen, Phone: 419-383-4516

GSK Clinical Trials Call Center, Tulsa, Oklahoma 74137, United States; Withdrawn

GSK Clinical Trials Call Center, Allentown, Pennsylvania 18103, United States; Recruiting
John Castaldo, Phone: 610-402-9008

GSK Clinical Trials Call Center, Philadelphia, Pennsylvania 19107, United States; Recruiting
David Tabby, Phone: 215-762-2518

GSK Clinical Trials Call Center, Charleston, South Carolina, United States; Recruiting
Hugh Durrence, MD, Phone: 843-795-1710

GSK Clinical Trials Call Center, Nashville, Tennessee 37203, United States; Recruiting
Jan Brandes, Phone: 615-284-4680

GSK Clinical Trials Call Center, Memphis, Tennessee 38018, United States; Recruiting
Stephen Landy, MD, Phone: 901-753-4093

GSK Clinical Trials Call Center, Dallas, Texas 75231, United States; Recruiting
John Claude Krusz, Phone: 214-750-6664

GSK Clinical Trials Call Center, Dallas, Texas 75390, United States; Not yet recruiting
Dion Graybeal

GSK Clinical Trials Call Center, San Antonio, Texas 78258, United States; Recruiting
Robert Nett, Phone: 210-949-0505

GSK Clinical Trials Call Center, Seattle, Washington 98104, United States; Recruiting
Sheena Aurora, MD, Phone: 206-215-3502

Starting date: October 2006
Last updated: June 4, 2007