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

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. 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, Stanford, California 06902, United States; Recruiting
Stewart Tepper, Phone: 203-322-2748

GSK Clinical Trials Call Center, Santa Monica, California 90404, United States; Recruiting
David Kudrow, Phone: 310-315-1456

GSK Clinical Trials Call Center, Newport Beach, California 92660, United States; Recruiting
Phillip O'Carroll, Phone: 949-759-8001

GSK Clinical Trials Call Center, Fresno, California 93720, United States; Recruiting
Melvin Helm, Phone: 559-435-6492

GSK Clinical Trials Call Center, Walnut Creek, California 94596, United States; Not yet recruiting
Michael Stein, Phone: 925-465-5454

GSK Clinical Trials Call Center, Fairfield, Connecticut 06824, United States; Recruiting
Peter McAllister, Phone: 203-333-1151

GSK Clinical Trials Call Center, Tallahassee, Florida 32308, United States; Recruiting
Ricardo Ayala, Phone: 850-656-6377

GSK Clinical Trials Call Center, Tampa, Florida 33609, United States; Recruiting
Robert Wilson, Phone: 813-353-9613

Jeffrey Gelblum, Miami, Florida, United States; Recruiting
Jeffrey Gelblum, MD, Phone: 305-931-8080

GSK Clinical Trials Call Center, Chicago, Illinois 60614, United States; Recruiting
George Urban, Phone: 773-388-6309

Daniel Wynn, Northbrook, Illinois, United States; Recruiting
Daniel Wynn, MD, Phone: 847-509-0270

Devin Zimmerman, South Bend, Illinois 46601, United States; Recruiting
Devin Zimmerman, MD, Phone: 574-282-2305

GSK Clinical Trials Call Center, Lenexa, Kansas 66214, United States; Recruiting
Dana Winegarner, Phone: 913-894-5000

GSK Clinical Trials Call Center, Golden Valley, Minnesota 55422, United States; Not yet recruiting
Jessica Heiring

GSK Clinical Trials Call Center, St Louis, Missouri 63110, United States; Recruiting
Todd Schwedt, Phone: 314-362-3888

GSK Clinical Trials Call Center, Omaha, Nebraska 68144, United States; Recruiting
John Kirchner, Phone: 402-758-2956

GSK Clinical Trials Call Center, Amherst, New York 14226, United States; Recruiting
Laslo Mechtler, Phone: 716-250-2055

GSK Clinical Trials Call Center, Greensboro, North Carolina 27401, United States; Recruiting
Marshall Freeman, Phone: 336-574-8000

GSK Clinical Trials Call Center, Matthews, North Carolina 28105, United States; Recruiting
Sara Sacco, Phone: 704-844-6615

Kenneth Carnes, Raleigh, North Carolina, United States; Recruiting
Kenneth Carnes, MD, Phone: 919-420-1659

GSK Clinical Trials Call Center, Tabor, North Carolina 28463, United States; Recruiting
Stephen Grubb, MD, Phone: 843-438-4062

GSK Clinical Trials Call Center, Fargo, North Dakota 58103, United States; Recruiting
Cynthia Knutson, Phone: 701-234-4094

GSK Clinical Trials Call Center, Dallas, Texas 75214, United States; Withdrawn

GSK Clinical Trials Call Center, Houston, Texas 77004, United States; Recruiting
Ninan Mathew, Phone: 713-528-1916

GSK Clinical Trials Call Center, Alexandria, Virginia 22304, United States; Recruiting
Stuart Stark, Phone: 703-212-5916

GSK Clinical Trials Call Center, Virginia Beach, Virginia 23452, United States; Recruiting
Neil Pugach, Phone: 757-368-4041

GSK Clinical Trials Call Center, Roanoke, Virginia 24018, United States; Recruiting
John Burch, Phone: 540-342-2929

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