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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
Show 84 Study Locations| 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 |