TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00387881
First received: October 11, 2006
Last updated: July 26, 2012
Last verified: May 2012
  Purpose

This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.


Condition Intervention Phase
Migraine, Without Aura
Drug: sumatriptan succinate / naproxen sodium
Drug: Placebo
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: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of TREXIMA* (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1) (*TREXIMET)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. [ Time Frame: 2 hours through 24 hours after Treatment ] [ Designated as safety issue: No ]
    Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.


Secondary Outcome Measures:
  • Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment [ Time Frame: 0.5, 1, and 4 hours after Treatment ] [ Designated as safety issue: No ]
    Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment.

  • Sustained Headache Relief 2-24 Hours After Treatment [ Time Frame: 2-24 hours after treatment ] [ Designated as safety issue: No ]
    Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication.

  • Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment [ Time Frame: 0.5, 1, 2, and 4 hours after treatment ] [ Designated as safety issue: No ]
    Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time.

  • Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment [ Time Frame: 0 - 24 hours after treatment ] [ Designated as safety issue: No ]
    Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack.

  • Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment [ Time Frame: 1-2, and 2- 4 hours after treatment ] [ Designated as safety issue: No ]
    Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.)

  • Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours [ Time Frame: 1-2 and 2-4 hours after treatment ] [ Designated as safety issue: No ]
    Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.)

  • Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment [ Time Frame: 2 and 4 hours after treatment ] [ Designated as safety issue: No ]
    Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.)

  • Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score [ Time Frame: 0 - 24 hours after treatment ] [ Designated as safety issue: No ]
    Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction.


Enrollment: 679
Study Start Date: September 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo to match Treximet tablets
Experimental: Treximet Drug: sumatriptan succinate / naproxen sodium
sumatriptan 85mg / naproxen sodium 500mg
Other Name: sumatriptan succinate / naproxen sodium

  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 probably migraine (6 migraine attacks per month)
  • Males and women of childbearing potential on a adequate contraception.

Exclusion Criteria:

  • Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use
  • 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 the 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: NCT00387881

  Show 68 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Silberstein S, Lipton RB, Goldstein J, Aurora SK, White J, Ochs-Ross R, Lener SE, McDonald SA. Evaluation of a New Fixed-dose Single Tablet of Sumatriptan Formulated with RT Technology and Naproxen Sodium (SumaRT/Nap) for the Acute Treatment of Probable Migraine without Aura. Headache 2008: presented at the American Headache Society Meeting, Boston, MA.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00387881     History of Changes
Other Study ID Numbers: TXA107563
Study First Received: October 11, 2006
Results First Received: February 19, 2009
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
sumatriptan succinate,
naproxen sodium,
parallel group,
double-blind,
placebo-controlled,
Combination product,
migrainous headache
Probable migraine, a sub-type of Migraine
probable migraine,

Additional relevant MeSH terms:
Migraine Disorders
Migraine without Aura
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