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Study Of Treximet, 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:
NCT00240617
First received: October 14, 2005
Last updated: October 24, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to determine the consistency of response for Treximet (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
Drug: sumatriptan succinate/naproxen sodium
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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 (*Treximet)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Score on a 4 pt migraine pain scale for multiple migraine attacks [ Time Frame: 2 to 24 hours ]

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 ]

Enrollment: 623
Study Start Date: October 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: arm 1
Treximet (sumatriptan/naproxen sodium) formerly known as TREXIMA
Drug: sumatriptan succinate/naproxen sodium
comparator
Placebo Comparator: arm 2
placebo to match
Drug: placebo
placebo to match

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240617

  Show 52 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: TRX103635
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: TRX103635
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: TRX103635
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: TRX103635
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: TRX103635
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: TRX103635
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: TRX103635
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00240617     History of Changes
Other Study ID Numbers: TRX103635 
Study First Received: October 14, 2005
Last Updated: October 24, 2016
Individual Participant Data  
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:
consistency of response
migraine
satisfaction
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
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 20, 2017