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Completed

NCT Number: NCT00329355

Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Dysmenorrhea Headache Headache Disorders Headache Disorders, Primary Menstruation Disturbances Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Chandler, Arizona, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sumatriptan succinate/naproxen sodium

Drug

Primary outcomes

  1. Score on a 4-pt migraine pain scale for a single menstrual migraine attack

    Time frame: 2 to 48 hours

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
May 24, 2006
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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