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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00382993 |
Purpose
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 |
|---|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 26 Study Locations| Study Chair: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Study ID Numbers: | TRX106573 |
| Study First Received: | September 29, 2006 |
| Last Updated: | August 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00382993 History of Changes |
| 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). |
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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 |
Eletriptan 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 |