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Efficacy of Combination Product (Sumatriptan Succinate/Naproxen Sodium) in Eletriptan Non-Responders.
This study has been completed.
First Received: September 29, 2006   Last Updated: August 20, 2008   History of Changes
Sponsor: 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)

Resource links provided by NLM:


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:
  • Migraine with or without aura (ICHD-II Criteria 1.2 or 1.1).

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. 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: NCT00383162

  Show 26 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Chair: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

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

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).

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 09, 2009