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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00329459 |
This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.
Condition | Intervention | Phase |
---|---|---|
Migraine |
Drug: sumatriptan succinate/naproxen sodium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 320 |
Study Start Date: | May 2006 |
A randomized, double-blind, single migraine attack, placebo-controlled, parallel group, multicenter study to evaluate the efficacy and tolerability of TREXIMA (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | TRX105850 |
Study First Received: | May 22, 2006 |
Last Updated: | May 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00329459 History of Changes |
Health Authority: | United States: Food and Drug Administration |
menstrual migraine dysmenorrhea headache early intervention |
Serotonin Agonists Anti-Inflammatory Agents Neurotransmitter Agents Naproxen Cyclooxygenase Inhibitors Central Nervous System Diseases Headache Disorders, Primary Cardiovascular Agents Brain Diseases Serotonin Headache Disorders |
Sumatriptan Dysmenorrhea Migraine Disorders Analgesics, Non-Narcotic Headache Vasoconstrictor Agents Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
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 |