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Efficacy of Combination Product (Sumatriptan Succinate/Naproxen Sodium) in Eletriptan Non-Responders.
This study has been completed.
Sponsored by: 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

Genetics Home Reference related topics: familial hemiplegic migraine
MedlinePlus related topics: Dietary Sodium Migraine
Drug Information available for: Succinic acid Naproxen Naproxen sodium Sumatriptan succinate Sumatriptan Eletriptan Eletriptan Hydrobromide
U.S. FDA Resources
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)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Proportion of subjects with Sustained Pain Free between 2-24hrs post dose.

Secondary Outcome Measures:
  • a.pain-free; b.recurrence; c.absence of nausea, photophobia, and phonophobia; d.relief from neck pain; e.relief from sinus pain; f.rescue medication

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
Criteria

Inclusion Criteria:

  • Consented males and nonpregnant females using adequate contraception, between 18 and 65 years of age, with at least 1-8 migraines per month for past 3 months. Eligible subjects must have been discontinued from eletriptan treatment within the past year due to poor response and/or intolerance.

Exclusion 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382993

  Show 26 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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  
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
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).

Study placed in the following topic categories:
Eletriptan
Sumatriptan
Naproxen
Migraine Disorders
Headache
Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009