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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00382993 |
Studies have been done to evaluate the efficacy of several triptans in patients who do not respond to sumatriptan. This study is a new concept to evaluate the new Combination Product in patients who do not respond to eletriptan.
Condition | Intervention | Phase |
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Migraine |
Drug: Combination Product (sumatriptan succinate / naproxen sodium) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Eletriptan (Study 2 of 2) |
Estimated Enrollment: | 167 |
Study Start Date: | October 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | TRX106573 |
Study First Received: | September 29, 2006 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00382993 |
Health Authority: | United States: Food and Drug Administration |
Combination product, sumatriptan succinate, naproxen sodium, crossover, double-blind, placebo-controlled, non-responders Migraine with or without aura (ICHD-II Criteria 1.2 or 1.1). |
Eletriptan Sumatriptan Naproxen Migraine Disorders Headache |
Central Nervous System Diseases Headache Disorders, Primary Brain Diseases Serotonin Headache Disorders |
Serotonin Agonists Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Cardiovascular Agents Gout Suppressants Pharmacologic Actions |
Serotonin Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |