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Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

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ClinicalTrials.gov Identifier: NCT00329355
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Migraine Migraine Disorders Drug: sumatriptan succinate/naproxen sodium Phase 3

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Score on a 4-pt migraine pain scale for a single menstrual migraine attack [ Time Frame: 2 to 48 hours ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329355


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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Additional Information:
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.  This link exits the ClinicalTrials.gov site

Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: TRX105852
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: TRX105852
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: TRX105852
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: TRX105852
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: TRX105852
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: TRX105852
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: TRX105852
For additional information about this study please refer to the GSK Clinical Study Register

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00329355     History of Changes
Other Study ID Numbers: TRX105852
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
menstrual migraine
headache
early intervention
dysmenorrhea

Additional relevant MeSH terms:
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Migraine Disorders
Dysmenorrhea
Premenstrual Syndrome
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Naproxen
 Sumatriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists