Trial record 18 of 502 for:    "Migraine Disorders"

Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00240630
First received: October 14, 2005
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.


Condition Intervention Phase
Migraine Disorders
Migraine
Drug: sumatriptan succinate/naproxen sodium
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Score on a migraine pain scale for multiple migraine attacks [ Time Frame: 2 to 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Within patient consistency of response, freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, recurrence of head pain, safety and tolerability [ Time Frame: 2 to 24 hours ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: October 2005
Arms Assigned Interventions
Placebo Comparator: Arm 1
placebo to match
Drug: sumatriptan succinate/naproxen sodium
Combination Tablet of Treximet
Other Name: sumatriptan succinate/naproxen sodium
Experimental: Arm 2
Treximet (sumatriptan/naproxen sodium)
Drug: placebo
placebo to match

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month.
  • Typically experiences moderate to severe migraine pain preceded by a mild pain phase.
  • Differentiate between mild migraine pain and other headache types.
  • Women of childbearing potential must be on adequate contraception.

Exclusion Criteria:

  • Pregnant and/or nursing mother.
  • History of cardiovascular disease.
  • Uncontrolled hypertension.
  • Basilar or Hemiplegic migraine.
  • History of stroke or transient ischemic attacks (TIA).
  • History of epilepsy or treated with anti-epileptics within past 5 years.
  • Impaired hepatic or renal function.
  • History of gastrointestinal bleeding or ulceration.
  • Allergy or hypersensitivity to Aspirin or any other NSAID.
  • Allergy or hypersensitivity to triptans.
  • Participated in an investigational drug trial in the previous 4 weeks.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240630

  Show 50 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00240630     History of Changes
Other Study ID Numbers: TRX103632
Study First Received: October 14, 2005
Last Updated: November 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
acute migraine
consistency of response
satisfaction
migraine
early intervention

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Naproxen
Sumatriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on April 15, 2014