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| Sponsored by: |
GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00383162 |
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 (Subject, Investigator), 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 1 of 2) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects were excluded for confirmed or suspected ischemic heart disease, uncontrolled hypertension at screening; a history of epilepsy or structural brain lesions which lowered the convulsive threshold; confirmed or suspected cardiovascular, cerebrovascular, peripheral vascular, congenital heart disease, or ischemic bowel disease; impaired hepatic or renal function; basilar or hemiplegic migraine. Other exclusion criteria included use of a monoamine oxidase inhibitor within 2 weeks before screening; ergot prophylactics in past 3 months; anticoagulants; opioid narcotics in past 6 months, had evidence of alcohol or substance abuse; recent gastric bypass surgery or other GI bleeding disorders, inflammatory bowel disease; ACE inhibitors; or any concurrent medical or psychiatric condition that in the investigator's opinion could affect interpretation of efficacy or safety information or which otherwise contraindicated participation in the study.
Contacts and Locations
Show 26 Study Locations| Study Chair: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline ( Deo S. Bukenya, Pharm.D. ) |
| Study ID Numbers: | TRX106571 |
| Study First Received: | September 29, 2006 |
| Last Updated: | August 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00383162 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 Eletriptan Anti-Inflammatory Agents Neurotransmitter Agents Naproxen Cyclooxygenase Inhibitors Central Nervous System Diseases Headache Disorders, Primary Cardiovascular Agents Brain Diseases Serotonin |
Headache Disorders Sumatriptan Migraine Disorders Analgesics, Non-Narcotic Headache Vasoconstrictor Agents Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
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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 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 |