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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00488514 |
Purpose
This study was designed to determine long-term safety of TREXIMA compared to placebo for the treatment of acute migraine.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: Combination Product (sumatriptan succinate / naproxen sodium) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | Study TXA107977, a Long-Term Safety Study of a Combination Product Containing Sumatriptan Succinate and Naproxen Sodium for the Treatment of Migraine in Adolescents |
| Estimated Enrollment: | 650 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
This study was designed to determine long-term safety of TREXIMA compared to placebo for the treatment of acute migraine.
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Valley Neurological Headache and Research Center | |
| Phoenix, Arizona, United States, 85014 | |
| Neurological Physicians of Arizona, Inc. | |
| Gilbert, Arizona, United States, 85234 | |
| United States, Arkansas | |
| Pediatric Neurology The Children's Clinic of Jonesboro | |
| Jonesboro, Arkansas, United States, 72401 | |
| Clinical Study Centers | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Med Investigations | |
| Fair Oaks, California, United States, 95628 | |
| Kratzer-Graves Pediatrics | |
| Fresno, California, United States, 93720 | |
| Stephen Forner, MD | |
| Chico, California, United States, 95926 | |
| San Francisco Clinical Research Center and Headache Clinic | |
| San Francisco, California, United States, 94109 | |
| UCSDn Stroke Center | |
| San Diego, California, United States, 92103 | |
| Fullerton Neurology and Headache | |
| Fullerton, California, United States, 92835 | |
| California Medical Clinic for Headaches | |
| Santa Monica, California, United States, 90404 | |
| Irvine Center for Clinical Research Inc. | |
| Irvine, California, United States, 92618 | |
| Philip O'Carroll MD Inc. | |
| Newport Beach, California, United States, 92660 | |
| Pediatric Care | |
| Huntington, California, United States, 92647 | |
| South Bay Neurology Research Center | |
| Redondo Beach, California, United States, 90277 | |
| Socklov Medical Research | |
| Sacramento, California, United States, 95825 | |
| Neurological Research Institute of the East Bay | |
| Walnut Creek, California, United States, 94596 | |
| Adult and Child Neurology | |
| Roseville, California, United States, 95678 | |
| Northridge Neurological Center | |
| Northridge, California, United States, 91325 | |
| Mark S. Wallace, MD | |
| La Jolla, California, United States, 92037 | |
| United States, Colorado | |
| Lynn Institute of the Rockies | |
| Colorado Springs, Colorado, United States, 80909 | |
| The Children's Hospital - Denver Neurology | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Hartford Headache Center | |
| Ridgfield, Connecticut, United States, 06877 | |
| Associated Neurologist of Southern Connecticut | |
| Fairfield, Connecticut, United States, 06824 | |
| United States, Florida | |
| Anchor Reserach A Division of Anchor Health Centers | |
| Naples, Florida, United States, 72401 | |
| Suncoast Medical Group | |
| St. Petersburg, Florida, United States, 33701 | |
| Suncoast Medical | |
| St. Petersberg, Florida, United States, 33701 | |
| Pediatric Neurology and Epilepsy Center | |
| Loxahatchee, Florida, United States, 33470 | |
| Child Neurology Clinic | |
| Pensacola, Florida, United States, 32504 | |
| Premiere Research Institute | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Savannah Neurology, PC | |
| Savannah, Georgia, United States, 31405 | |
| Child Neurology Associates, P.C. | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Idaho | |
| Pediatric Neurology of Idaho | |
| Boise, Idaho, United States, 83712 | |
| United States, Indiana | |
| Community Clinical Research Center | |
| Anderson, Indiana, United States, 46011 | |
| United States, Kansas | |
| Vince & Associates | |
| Overland Park, Kansas, United States, 66212 | |
| United States, Kentucky | |
| CNS Associates, Inc. | |
| Murray, Kentucky, United States, 42071 | |
| Kentucky Pediatric/Adult Relationship | |
| Bardstown, Kentucky, United States, 40004 | |
| United States, Maryland | |
| Child and Adolescent Neurology | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Michigan | |
| ProMed Pediatrics | |
| Protage, Michigan, United States, 49024 | |
| Women's Health Care Specialists, P.C. | |
| Paw Paw, Michigan, United States, 49079 | |
| ProMed Pediatrics | |
| Kalamazoo, Michigan, United States, 97210 | |
| Michigan Head Pain & Neurological Institute | |
| Ann Arbor, Michigan, United States, 48104 | |
| Borgess Research Institute | |
| Kalamazoo, Michigan, United States, 49043 | |
| United States, Minnesota | |
| Clinical Research Institute | |
| Minneapolis, Minnesota, United States, 55402 | |
| United States, Missouri | |
| Mercy Health Research Ryan Headache Center | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Midwest Allergy and Asthma Clinic | |
| Omaha, Nebraska, United States, 68130 | |
| United States, Nevada | |
| Lovelace Scientific Resources, Inc. | |
| Las Vegas, Nevada, United States, 89148 | |
| United States, New Hampshire | |
| Dartmouth Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Childrens Neurology | |
| Morristown, New Jersey, United States, 07960 | |
| Pediatric Clinical Research Center | |
| New Brunswick, New Jersey, United States, 08901 | |
| The Center for Neurological & Neurodevelopmental Health Clinical Research Center of New Jersey | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New Mexico | |
| Lovelace Scientific Resources | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| Braverman-Panza Medical Group | |
| Albany, New York, United States, 12206 | |
| Rochester Clinical Research | |
| Rochester, New York, United States, 14609 | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| Gosy & Associates Pain Treatment and Neurology, LLP | |
| Williamsville, New York, United States, 14221 | |
| The Elkind Headache Clinic | |
| Mt Vernon, New York, United States, 10550 | |
| Neurology Group of Bergen County, P. A. | |
| Ridgewood, New York, United States, 07450 | |
| Dent Neurologic Institute | |
| Amherst, New York, United States, 14226 | |
| Analgesic Development Ltd. | |
| New York, New York, United States, 10022 | |
| Regional Clinical Research | |
| Endwell, New York, United States, 13760 | |
| Island Neurological Associates | |
| Plainview, New York, United States, 11803 | |
| United States, North Carolina | |
| Raleigh Neurology Associates | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Ohio | |
| Cincinnati Children's Hospital | |
| Cincinnati, Ohio, United States, 45229 | |
| OrthoNeuro | |
| Westerville, Ohio, United States, 43018 | |
| Childrens Hospital | |
| Columbus, Ohio, United States, 43018 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Lynn Health Science Institute | |
| Oklahama City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Pacific Women's Center | |
| Eugene, Oregon, United States, 97401 | |
| Medford Neurologic Spine Center | |
| Medford, Oregon, United States, 97504 | |
| Oregon Center for Clinical Investigations, Inc. | |
| Portland, Oregon, United States, 97210 | |
| United States, South Carolina | |
| Mountain View Clinical Research | |
| Greer, South Carolina, United States, 29349 | |
| United States, Tennessee | |
| Nashville Neurosciences Group | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Neurology, Headache & Pain Control Center | |
| Nassau Bay, Texas, United States, 77058 | |
| Texas Child Neurology | |
| Plano, Texas, United States, 75075 | |
| Radiant Research | |
| San Antonio, Texas, United States, 78229 | |
| Dallas Pediatric Neurology Associates | |
| Dallas, Texas, United States, 75230-2507 | |
| Georgetown Medical Center Clinic | |
| Georgetown, Texas, United States, 78628 | |
| United States, Utah | |
| Foothill Family Clinic South | |
| Salt Lake City, Utah, United States, 84121 | |
| J. Lewis Research, Inc. | |
| Salt Lake City, Utah, United States, 84109 | |
| United States, Virginia | |
| Monarch Medical Research | |
| Norfolk, Virginia, United States, 23510 | |
| Pedeatric Research of Charlottesville, LLC | |
| Charolottesville, Virginia, United States, 22902 | |
| United States, Washington | |
| Kitsap Center for Clinical Studies | |
| Bremerton, Washington, United States, 98310 | |
| Wenatchee Valley Medical Center | |
| Wenatchee, Washington, United States, 98801 | |
| Study Chair: | Clinical Trials GlaxoSmithKline | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline ( Frederick Derosier, DO ) |
| Study ID Numbers: | TXA107977 |
| Study First Received: | June 18, 2007 |
| Last Updated: | August 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00488514 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Migraine Adolescent Migraine Headache Long-term Safety sumatriptan succinate naproxen sodium |
|
Serotonin Agonists Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Headache Disorders, Primary Brain Diseases Gout Suppressants Headache Disorders Sensory System Agents Migraine Disorders Therapeutic Uses Vasoconstrictor Agents Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Naproxen Nervous System Diseases Cyclooxygenase Inhibitors Central Nervous System Diseases Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Sumatriptan Serotonin Agents Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |