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)

PHASE3CompletedINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

October 31, 2007

Study Completion Date

October 31, 2007

Conditions
Migraine Disorders
Interventions
DRUG

Combination Product (sumatriptan succinate / naproxen sodium)

Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in the second layer.

DRUG

Placebo

Matching placebo tablet.

Trial Locations (26)

14127

GSK Investigational Site, Orchard Park

22304

GSK Investigational Site, Alexandria

23452

GSK Investigational Site, Virginia Beach

24013

GSK Investigational Site, Roanoke

27401

GSK Investigational Site, Greensboro

27607

GSK Investigational Site, Raleigh

28105

GSK Investigational Site, Matthews

28463

GSK Investigational Site, Tabor City

32308

GSK Investigational Site, Tallahassee

33180

GSK Investigational Site, Aventura

33609

GSK Investigational Site, Tampa

46601

GSK Investigational Site, South Bend

58103

GSK Investigational Site, Fargo

60062

GSK Investigational Site, Northbrook

60614

GSK Investigational Site, Chicago

63110

GSK Investigational Site, St Louis

66214

GSK Investigational Site, Lenexa

68144

GSK Investigational Site, Omaha

75214

GSK Investigational Site, Dallas

77004

GSK Investigational Site, Houston

90404

GSK Investigational Site, Santa Monica

92660

GSK Investigational Site, Newport Beach

93720

GSK Investigational Site, Fresno

94596

GSK Investigational Site, Walnut Creek

06824

GSK Investigational Site, Fairfield

06902

GSK Investigational Site, Stamford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY