Full Text View
Tabular View
No Study Results Posted
Related Studies
TREXIMA Versus Butalbital-Containing Combination Medications for the Acute Treatment of Migraine in Adults
This study is currently recruiting participants.
Verified by GlaxoSmithKline, April 2009
First Received: December 12, 2007   Last Updated: April 2, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00573170
  Purpose

This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, crossover, three-attack, outpatient study in which TREXIMA will be compared to a butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg [Fioricet]) for the acute treatment of migraine headaches. Subjects will be randomized to one of 6 possible treatment sequences (TPB, TBP, BTP, BPT, PTB, PBT). Subjects will treat each of the 3 migraine attacks when pain is moderate to severe. (T = TREXIMA; P = placebo; B = butalbital) The study will include 4 visits: (1) a Screening visit at study entry, (2) a Drug Screen visit, (3) a Randomization visit, (4) a Final visit. The Final visit occurs either (A) upon withdrawal, or (B), after treatment of 3 migraine attacks, or C) if the study concludes prior to the subject treating 3 attacks. The primary objective is to evaluate the efficacy of TREXIMA versus BCM for the acute treatment of moderate/severe migraine.


Condition Intervention Phase
Migraine
Drug: Trexima
Drug: Butalbital-containing Combination Medications (BCM)
Drug: butalbital
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Subjects with a sustained pain-free (SPF) response from 2-24 hours in subjects using TREXIMA versus those using BCM [ Time Frame: 2-24 hours ]

Secondary Outcome Measures:
  • Subjects who are pain-free (PF) at 2 hours post-treatment [ Time Frame: 2-48 hours ]
  • Effects on cognition of treating with BCM vs TREXIMA (as measured by the Mental Efficiency Workload Test (MEWT), measured at 2, 4, 6, 8, 24, and 48 hours [ Time Frame: 2-48 hours ]
  • Subjects who use rescue medi [ Time Frame: 2-48 hours ]

Estimated Enrollment: 500
Study Start Date: February 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Active Comparator Drug: Trexima
Sumatriptan + Naproxen Sodium
Drug: Butalbital-containing Combination Medications (BCM)
butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg [Fioricet])
Drug: butalbital
butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg [Fioricet])

Detailed Description:

Study TRX109011, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMA™ (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain Phase of the Migraine (Study 1 of 2)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females aged 18 to 65 years. If female, using contraception if sexually active and not breastfeeding. If using oral contraceptives, the subjects should be on a stable regimen of oral contraceptives (> 2 months).
  • Subjects must have an active prescription for a butalbital-containing medication (BCM), must be currently using it as their primary treatment of migraine, and must have used the BCM to treat at least one migraine within the past 30 days.
  • Subjects must have migraine with or without aura (2004 ICHD-II criteria) and must have had at least 2 attacks per month meeting these criteria in three months prior to screening.
  • Subjects must be able to understand how to complete the cognitive assessments and all other questionnaires programmed in an electronic diary (eDiary).
  • Subject must be able to read English or Spanish and comprehend protocol requirements
  • Subject is willing and able to provide written informed consent.

Exclusion Criteria:

  • Subject has >8 migraines or 15 headache days per month in total
  • Subject has taken >350mg/day of butalbital and/or other barbiturates on average over the 30 days prior to screening.
  • Subject has a history of heart disease, abdominal perforation or surgery, abdominal ulcer in last 6 months, abdominal bleeding in last 12 months, bowel disease, and any bleeding disorder
  • Subject has allergy, intolerance, or contraindication to the use of any triptan, NSAID, aspirin, barbituates, or acetaminophen (including all sumatriptan and naproxen preparations), has porphyria or has nasal polyps and asthma.
  • Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a migraine or prophylactic medication that is not stabilized (i.e. change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
  • Subject has a recent history of regular use of opioids or barbiturates, other than Butalbital, for the treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months
  • Subject has participated in an investigational drug trial within the previous four weeks or plans to participate in another study at any time during this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573170

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site Completed
Tempe, Arizona, United States, 85283
GSK Investigational Site Completed
Litchfield Park, Arizona, United States, 85340
GSK Investigational Site Withdrawn
Sun City, Arizona, United States, 85351
GSK Investigational Site Completed
Chandler, Arizona, United States, 85224
GSK Investigational Site Withdrawn
Phoenix, Arizona, United States, 85015
United States, Arkansas
GSK Investigational Site Recruiting
Little Rock, Arkansas, United States, 72201
United States, California
GSK Investigational Site Recruiting
Irvine, California, United States, 92618
GSK Investigational Site Recruiting
San Diego, California, United States, 92108
GSK Investigational Site Recruiting
Sherman Oaks, California, United States, 91403
GSK Investigational Site Withdrawn
Encinitas, California, United States, 92024
GSK Investigational Site Recruiting
Santa Monica, California, United States, 90404
GSK Investigational Site Withdrawn
Los Angeles, California, United States, 90033
GSK Investigational Site Withdrawn
Aliso Viejo, California, United States, 92656
GSK Investigational Site Withdrawn
Fresno, California, United States, 93720
GSK Investigational Site Recruiting
Walnut Creek, California, United States, 94596
GSK Investigational Site Withdrawn
Pasadena, California, United States, 91106
GSK Investigational Site Withdrawn
Chino, California, United States, 91710
GSK Investigational Site Withdrawn
Garden Grove, California, United States, 92845
GSK Investigational Site Withdrawn
San Diego, California, United States, 92103-8411
GSK Investigational Site Withdrawn
Orange, California, United States, 92868
GSK Investigational Site Not yet recruiting
Anaheim, California, United States, 92801
United States, Colorado
GSK Investigational Site Recruiting
Colorado Springs, Colorado, United States, 80909
GSK Investigational Site Withdrawn
Wheat Ridge, Colorado, United States, 80033
GSK Investigational Site Withdrawn
Aurora, Colorado, United States, 80012
GSK Investigational Site Withdrawn
Boulder, Colorado, United States, 80304
United States, Connecticut
GSK Investigational Site Withdrawn
Stamford, Connecticut, United States, 06902
GSK Investigational Site Withdrawn
New Britain, Connecticut, United States, 06050
GSK Investigational Site Withdrawn
Waterbury, Connecticut, United States, 06708
United States, Delaware
GSK Investigational Site Withdrawn
Wilmington, Delaware, United States, 19806
United States, District of Columbia
GSK Investigational Site Withdrawn
Washington, District of Columbia, United States, 20037
GSK Investigational Site Withdrawn
Washington, District of Columbia, United States, 20060
United States, Florida
GSK Investigational Site Withdrawn
Miami, Florida, United States, 33143
GSK Investigational Site Recruiting
Naples, Florida, United States, 34102
GSK Investigational Site Withdrawn
Deland, Florida, United States, 32720
GSK Investigational Site Recruiting
West Palm Beach, Florida, United States, 33407-2450
GSK Investigational Site Withdrawn
Jacksonville, Florida, United States, 32266
GSK Investigational Site Withdrawn
Fort Myers, Florida, United States, 33912
GSK Investigational Site Withdrawn
Melbourne, Florida, United States, 32901
GSK Investigational Site Recruiting
Plantation, Florida, United States, 33324
GSK Investigational Site Withdrawn
Jacksonville, Florida, United States, 32216
GSK Investigational Site Recruiting
Pembroke Pines, Florida, United States, 33024
GSK Investigational Site Withdrawn
Maitland, Florida, United States, 32751
GSK Investigational Site Recruiting
Clearwater, Florida, United States, 33755
United States, Georgia
GSK Investigational Site Withdrawn
Stockbridge, Georgia, United States, 30281
GSK Investigational Site Withdrawn
Royston, Georgia, United States, 30662
GSK Investigational Site Withdrawn
Marietta, Georgia, United States, 30060
GSK Investigational Site Withdrawn
Atlanta, Georgia, United States, 30309
GSK Investigational Site Withdrawn
Atlanta, Georgia, United States, 30342
GSK Investigational Site Withdrawn
Savannah, Georgia, United States, 31405
GSK Investigational Site Withdrawn
Smyrna, Georgia, United States, 30080
GSK Investigational Site Withdrawn
Roswell, Georgia, United States, 30076
GSK Investigational Site Recruiting
Suwanee, Georgia, United States, 30024
GSK Investigational Site Completed
Rome, Georgia, United States, 30165
GSK Investigational Site Withdrawn
Atlanta, Georgia, United States, 30308
GSK Investigational Site Withdrawn
Jesup, Georgia, United States, 31545
GSK Investigational Site Active, not recruiting
Savannah, Georgia, United States, 31406
GSK Investigational Site Active, not recruiting
Atlanta, Georgia, United States, 30342
GSK Investigational Site Completed
Atlanta, Georgia, United States, 30308
United States, Illinois
GSK Investigational Site Active, not recruiting
Chicago, Illinois, United States, 60614
GSK Investigational Site Recruiting
Gurnee, Illinois, United States, 60031
GSK Investigational Site Withdrawn
Maywood, Illinois, United States, 60153
GSK Investigational Site Withdrawn
Chicago, Illinois, United States, 60637
GSK Investigational Site Withdrawn
Urbana, Illinois, United States, 61801
United States, Indiana
GSK Investigational Site Withdrawn
Evansville, Indiana, United States, 47714
GSK Investigational Site Withdrawn
Evansville, Indiana, United States, 47712
GSK Investigational Site Completed
Indianapolis, Indiana, United States, 46256
United States, Kansas
GSK Investigational Site Withdrawn
Lenexa, Kansas, United States, 66214
United States, Kentucky
GSK Investigational Site Withdrawn
Lexington, Kentucky, United States, 40503
GSK Investigational Site Recruiting
Paducah, Kentucky, United States, 42003
United States, Louisiana
GSK Investigational Site Recruiting
Shreveport, Louisiana, United States, 71101
GSK Investigational Site Withdrawn
Shreveport, Louisiana, United States, 71103
GSK Investigational Site Not yet recruiting
New Orleans, Louisiana, United States, 70121
United States, Maryland
GSK Investigational Site Withdrawn
Rockville, Maryland, United States, 20852
United States, Massachusetts
GSK Investigational Site Withdrawn
Westfield, Massachusetts, United States, 01085
GSK Investigational Site Recruiting
Springfield, Massachusetts, United States, 01104
GSK Investigational Site Withdrawn
Worcester, Massachusetts, United States, 1605
GSK Investigational Site Withdrawn
Lenox, Massachusetts, United States, 01240
GSK Investigational Site Withdrawn
Plymouth, Massachusetts, United States, 02360
United States, Michigan
GSK Investigational Site Withdrawn
Flint, Michigan, United States, 48506
GSK Investigational Site Withdrawn
Troy, Michigan, United States, 48098
GSK Investigational Site Withdrawn
Okemos, Michigan, United States, 48864
GSK Investigational Site Withdrawn
Farmington Hills, Michigan, United States, 48334
GSK Investigational Site Withdrawn
Ann Arbor, Michigan, United States, 48104
GSK Investigational Site Recruiting
Ann Arbor, Michigan, United States, 48104
GSK Investigational Site Withdrawn
Kalamazoo, Michigan, United States, 49008
United States, Minnesota
GSK Investigational Site Withdrawn
Rochester, Minnesota, United States, 55905
United States, Nevada
GSK Investigational Site Withdrawn
Las Vegas, Nevada, United States, 89104
GSK Investigational Site Withdrawn
Las Vegas, Nevada, United States, 89146
United States, New Hampshire
GSK Investigational Site Withdrawn
Derry, New Hampshire, United States, 03038
GSK Investigational Site Withdrawn
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
GSK Investigational Site Withdrawn
Ridgewood, New Jersey, United States, 7450
GSK Investigational Site Withdrawn
Toms River, New Jersey, United States, 08753
GSK Investigational Site Withdrawn
Berlin, New Jersey, United States, 08009
GSK Investigational Site Withdrawn
Haddon Heights, New Jersey, United States, 08035
GSK Investigational Site Recruiting
Cherry Hill, New Jersey, United States, 08002
GSK Investigational Site Completed
Ridgewood, New Jersey, United States, 7450
GSK Investigational Site Recruiting
Stratford, New Jersey, United States, 08084
GSK Investigational Site Withdrawn
Ridgewood, New Jersey, United States, 07550
United States, New York
GSK Investigational Site Withdrawn
Brooklyn, New York, United States, 11235
GSK Investigational Site Withdrawn
Rochester, New York, United States, 14642
GSK Investigational Site Withdrawn
Lawrence, New York, United States, 11559
GSK Investigational Site Recruiting
Brooklyn, New York, United States, 11235
GSK Investigational Site Recruiting
Syracuse, New York, United States, 13210
GSK Investigational Site Recruiting
Mount Vernon, New York, United States, 10550
GSK Investigational Site Withdrawn
Schenectady, New York, United States, 12308
GSK Investigational Site Withdrawn
Endwell, New York, United States, 13760
GSK Investigational Site Completed
Valley Stream, New York, United States, 11580
GSK Investigational Site Completed
Bronx, New York, United States, 10461
GSK Investigational Site Completed
New York, New York, United States, 10021
GSK Investigational Site Withdrawn
Camillus, New York, United States, 13031
GSK Investigational Site Withdrawn
Syracuse, New York, United States, 13210
GSK Investigational Site Withdrawn
Albany, New York, United States, 12208
GSK Investigational Site Recruiting
Orchard Park, New York, United States, 14127
GSK Investigational Site Recruiting
Albany, New York, United States, 12205
United States, North Carolina
GSK Investigational Site Withdrawn
Raleigh, North Carolina, United States, 27612
GSK Investigational Site Completed
Charlotte, North Carolina, United States, 28204
GSK Investigational Site Withdrawn
Winston-Salem, North Carolina, United States, 27103
GSK Investigational Site Recruiting
Cary, North Carolina, United States, 27518
GSK Investigational Site Not yet recruiting
Greenville, North Carolina, United States, 27834
GSK Investigational Site Withdrawn
Gastonia, North Carolina, United States, 28054
GSK Investigational Site Recruiting
Wilmington, North Carolina, United States, 28401
GSK Investigational Site Withdrawn
Charlotte, North Carolina, United States, 28204
United States, North Dakota
GSK Investigational Site Completed
Bismarck, North Dakota, United States, 58501
United States, Ohio
GSK Investigational Site Withdrawn
Cleveland, Ohio, United States, 44122
GSK Investigational Site Withdrawn
Columbus, Ohio, United States, 43210
GSK Investigational Site Withdrawn
Columbus, Ohio, United States, 43213
GSK Investigational Site Withdrawn
Akron, Ohio, United States, 44302
GSK Investigational Site Withdrawn
Tiffin, Ohio, United States, 44883
GSK Investigational Site Recruiting
Cincinnati, Ohio, United States, 45227
GSK Investigational Site Recruiting
Toledo, Ohio, United States, 43614-5809
GSK Investigational Site Recruiting
Cincinnati, Ohio, United States, 45245
United States, Oklahoma
GSK Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site Withdrawn
Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site Withdrawn
Norman, Oklahoma, United States, 73071
GSK Investigational Site Withdrawn
Yukon, Oklahoma, United States, 73099
GSK Investigational Site Withdrawn
Tulsa, Oklahoma, United States, 74137
GSK Investigational Site Withdrawn
Tulsa, Oklahoma, United States, 74136
United States, Oregon
GSK Investigational Site Withdrawn
Portland, Oregon, United States, 97213
GSK Investigational Site Withdrawn
Eugene, Oregon, United States, 97401
GSK Investigational Site Withdrawn
Portland, Oregon, United States, 97239
GSK Investigational Site Withdrawn
Ashland, Oregon, United States, 97520
United States, Pennsylvania
GSK Investigational Site Withdrawn
Natrona Heights, Pennsylvania, United States, 15065
GSK Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19114
GSK Investigational Site Completed
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15236
GSK Investigational Site Withdrawn
Pittsburgh, Pennsylvania, United States, 15213
GSK Investigational Site Withdrawn
Media, Pennsylvania, United States, 19063
United States, South Carolina
GSK Investigational Site Withdrawn
Mount Pleasant, South Carolina, United States, 29464
GSK Investigational Site Withdrawn
Charleston, South Carolina, United States, 29412
GSK Investigational Site Withdrawn
Greenville, South Carolina, United States, 29605
GSK Investigational Site Completed
Simpsonville, South Carolina, United States, 29681
GSK Investigational Site Withdrawn
Beaufort, South Carolina, United States, 29902
United States, South Dakota
GSK Investigational Site Withdrawn
Rapid City, South Dakota, United States, 57702
United States, Tennessee
GSK Investigational Site Completed
Columbia, Tennessee, United States, 38401
GSK Investigational Site Completed
Cordova, Tennessee, United States, 38018
GSK Investigational Site Withdrawn
Knoxville, Tennessee, United States, 37923
GSK Investigational Site Withdrawn
Johnson City, Tennessee, United States, 37604
GSK Investigational Site Completed
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site Withdrawn
Austin, Texas, United States, 78756
GSK Investigational Site Withdrawn
El Paso, Texas, United States, 79902
GSK Investigational Site Withdrawn
Dallas, Texas, United States, 75203
GSK Investigational Site Withdrawn
Houston, Texas, United States, 77074
GSK Investigational Site Recruiting
Dallas, Texas, United States, 75231
GSK Investigational Site Withdrawn
Dallas, Texas, United States, 75231
GSK Investigational Site Withdrawn
San Antonio, Texas, United States, 78229
GSK Investigational Site Withdrawn
Round Rock, Texas, United States, 78681
GSK Investigational Site Recruiting
Dallas, Texas, United States, 75234
United States, Utah
GSK Investigational Site Withdrawn
Salt Lake City, Utah, United States, 84121
GSK Investigational Site Recruiting
Salt Lake City, Utah, United States, 84107
United States, Virginia
GSK Investigational Site Withdrawn
Midlothian, Virginia, United States, 23112
GSK Investigational Site Withdrawn
Richmond, Virginia, United States, 23298
GSK Investigational Site Withdrawn
Herndon, Virginia, United States, 20170
United States, Washington
GSK Investigational Site Withdrawn
Tacoma, Washington, United States, 98401
GSK Investigational Site Withdrawn
Seattle, Washington, United States, 98104
United States, Wisconsin
GSK Investigational Site Withdrawn
Racine, Wisconsin, United States, 53404
Puerto Rico
GSK Investigational Site Withdrawn
San Juan, Puerto Rico, 00926
GSK Investigational Site Withdrawn
Carolina, Puerto Rico, 00983
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: TRX109011
Study First Received: December 12, 2007
Last Updated: April 2, 2009
ClinicalTrials.gov Identifier: NCT00573170     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Migraine
Butalbital-containing Combination Medication (BCM)
Sumatriptan succinate
Naproxen sodium
TREXIMA

Additional relevant MeSH terms:
Migraine Disorders
Nervous System Diseases
Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Headache Disorders

ClinicalTrials.gov processed this record on November 30, 2009