This study was designed to determine the efficacy and tolerability of TREXIMA compared to placebo for the acute treatment of probable migraine, a sub-type of migraine...
Date First Received: October 11, 2006
Last Updated: December 18, 2007
Verified by: Pozen, December 2007
Clinical Trial Phase: Phase 3 | Start Date:
Overall Status: Active, not recruiting
Estimated Enrollment: 20
Brief Summary
Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Tolerability of TREXIMA(tm) (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1)”
Condition Keyword(s):
Intervention(s):
This study was designed to determine the efficacy and tolerability of TREXIMA compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
Phase 3 Inverventional
Outcome Measures for this Clinical Trial
Primary:
- Score on a migraine pain scale at 2 hours through 24 hours for a single probable migraine attack.
Secondary:
- Freedom from all migraine pain and symptoms, satisfaction, recurrence of head pain, safety and tolerability.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- At least a 6 month history of probably migraine (6 migraine attacks per month)
- Males and women of childbearing potential on a adequate contraception.
Exclusion Criteria:
- Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use
- Pregnant and/or nursing mother
- History of cardiovascular disease.
- Uncontrolled hypertension.
- Basilar or Hemiplegic migraine
- History of stroke or transient ischemic attacks (TIA).
- History of epilepsy or treated with anti-epileptics within the past 5 years.
- Impaired hepatic or renal function.
- History of gastrointestinal bleeding or ulceration.
- Allergy or hypersensitivity to Aspirin or any other NSAID.
- Allergy or hypersensitivity to triptans.
- Participated in an investigational drug trial in the previous 4 weeks.
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Pozen
HOPE Research Institute
Phoenix Arizona 85050 United States
Central Phoenix Medical Clinic
Phoenix Arizona 85014 United States
Clinical Study Centers
Little Rock Arkansas 72205 United States
NuLife Clinical Research, Inc.
Anaheim California 92805 United States
Centre for Health Care
San Diego California 92128 United States
San Francisco Clinical Research Center
San Francisco California 94109 United States
NuLife Clinical Research, Inc.
Anaheim California 92805 United States
Clinical Neurology and Electromyography
Newport Beach California 92660 United States
Westlake Medical Research
Westlake Village California 91361 United States
Advanced Clinical Research Institute
Anaheim California 92801 United States
Neurological Research Institute of the East Bay
Walnut Creek California 94596 United States
Neurological Research Institute
Santa Monica California 90404 United States
Clinicos, Llc
Colorado Springs Colorado 80904 United States
The New England Center for Headaches, PC
Stamford Connecticut 06902 United States
University Clinical Research, Inc.
Pembroke Pines Florida 33024 United States
Research Consultants Group
Miami Florida 33144 United States
Neurology & Headache Specitalists of Atlanta, LCC
Decatur Georgia 30033 United States
Georgia Clinical Research
Atlanta Georgia 30308 United States
Neurology & Headache Specitalists of Atlanta, LCC
Decatur Georgia 30033 United States
Diamond Headache Clinic
Chicago Illinois 60614 United States
Oliver Headache and Pain Clinic
Evansville Indiana 47712 United States
Heartland Research
Wichita Kansas 67207 United States
Ochsner Clinic Foundation
New Orleans Louisiana 70121 United States
Northeast Medical Research Associates
North Dartmouth Massachusetts 02747 United States
Michigan Head Pain and Neurological Institute
Ann Arbor Michigan 48104 United States
Park Nicollet Health Services
Minneapolis Minnesota 55426 United States
Mercy Health Research
St. Louis Missouri 63141 United States
Headache Care Center, Clinvest, Inc.
Springfield Missouri 65807 United States
Radiant Research
Las Vegas Nevada 89146 United States
Lovelace Scientific Research
Albuquerque New Mexico 87108 United States
Braveman-Panza Medical Group
Albany New York 12206 United States
North Shore Pain Services, LLP
Valley Stream New York 11580 United States
University of Rochester
Rochester New York 14642 United States
Montefiore Memorial Hospital
Bronx New York 10461 United States
Analgesic Development Ltd.
New York New York 10022 United States
UNC Chapel Hill
Chapel Hill North Carolina 27599 United States
Headache Wellness Center
Greensboro North Carolina 27401 United States
Triangle Medical Research Associates
Raleigh North Carolina 27609 United States
UNC Chapel Hill
Chapel Hill North Carolina 27599 United States
ClinExcel Research
West Chester Ohio 45069 United States
New Albany Surgical Hospital Foundation
Westerville Ohio 43081 United States
The Cleveland Clinic Founcation
Cleveland Ohio 44195 United States
Community Research
Cincinnati Ohio 45245 United States
Community Research
Cincinnati Ohio 45245 United States
Medford Neurological & Spine Clinic
Medford Oregon 97504 United States
Preferred Primary Care Physicians
Pittsburg Pennsylvania 15236 United States
University of Pittsburgh
Pittsburgh Pennsylvania 15213 United States
Jefferson Headache Center
Philadelphia Pennsylvania 19107 United States
Radiant Research
Anderson South Carolina 29621 United States
Hillcrest Clinical Research, LLC
Simpsonville South Carolina 29681 United States
Nashville Neuroscience Group
Nashville Tennessee 37203 United States
Benchmark Research
Austin Texas 78705 United States
Neuro
Houston Texas 77030 United States
Bellaire Neurology
Bellaire Texas 77401 United States
Clinical Researchers of South Texas
Katy Texas 77450 United States
Innovative Clinical Trials
San Antonio Texas 78229 United States
Primary Care
Austin Texas 78745 United States
Foothill Family Clinicl South
Salt Lake City Utah 84121 United States
Holladay Family Practice
Salt Lake City Utah 84107 United States
Foothill Family Clinic
Salt Lake City Utah 84109 United States
Southwest Family Medicine
West Jordan Utah 84084 United States
Holladay Family Practice
Salt Lake Utah 84107 United States
Alexandria Fairfax Neurology, PC
Alexandria Virginia 22311 United States
Swedsih Medical Center
Seattle Washington 98104 United States
Wentachee Valley Medical Center
Wenatchee Washington 98801 United States
University of Washington Medical Center
Seattle Washington 98105 United States
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00387881
Study ID Number: TXA107563
ClinicalTrials.gov Identifier: NCT00387881
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
