Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00329355
First received: May 22, 2006
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Score on a 4-pt migraine pain scale for a single menstrual migraine attack [ Time Frame: 2 to 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, menstrual symptoms, recurrence of head pain, safety and tolerability [ Time Frame: 2 to 48 hours ] [ Designated as safety issue: No ]

Enrollment: 320
Study Start Date: May 2006
Intervention Details:
    Drug: sumatriptan succinate/naproxen sodium
    Other Name: sumatriptan succinate/naproxen sodium
Detailed Description:

A randomized, double-blind, single migraine attack, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and tolerability of TREXIMA* (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea (*TREXIMET)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
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: NCT00329355

  Show 35 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00329355     History of Changes
Other Study ID Numbers: TRX105852
Study First Received: May 22, 2006
Last Updated: November 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
menstrual migraine
headache
dysmenorrhea
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 23, 2014