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Protocol Summary for TRX109013

Protocol Summary
Protocol Id: TRX109013
Secondary Ids:
  • N/A
Title: A Crossover, Randomized, Double-blind, Double-dummy, Placebo-controlled Study to Evaluate the Efficacy of TREXIMET®/Sumatriptan + Naproxen Sodium vs. Butalbital-containing Combination Medications for the Acute Treatment of Migraine when administered during Moderate-Severe Migraine Pain, 2 of 2
Phase: phase 3
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 68,436
IND/IDE Serial Number: 072
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
  • N/A
Brief Summary: Study TRX109013, A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (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 2 of 2)
Detailed Description: This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, crossover, three-attack, outpatient study in which TREXIMET® 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 where T = TREXIMET®, P = Placebo, B = Butalbital-containing Combination Medication). Subjects will treat each of the 3 migraine attacks when pain is moderate to severe. The study will include 4 visits: (1) a Screening Visit at study entry, (2) a Drug Screen Visit, (3) a Randomization Visit, and (4) a Final Visit. The Final Visit occurs either (A) upon withdrawal or (B) after treatment of 3 migraine attacks. The primary objective is to evaluate the efficacy of TREXIMET® versus BCM for the acute treatment of moderate/severe migraine.
Record Verification Date:
Status: Completed
Why Study Stopped:
Study Start Date: December 2007
Study Completion Date: July 2009
Study Completion Date Type: Actual
Primary Completion Date: July 2009
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: yes
Masked Assessor: no
Study Design (Assignment): Crossover Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Subjects with a sustained pain-free (SPF) response from 2-24 hours in subjects using TREXIMET® versus those using BCM. 2-24 hours
Secondary Outcomes:
  • Pain and traditional and non-traditional associated migraine symptoms including nausea, vomiting, photophobia, phonophobia, sinus pain, neck pain, irritability, and tiredness. 0-48 hours after treatment
  • Rescue medication usage after treatment of migraine. 0-48 hours after treatment
  • Pain-free (PF) at 2 hours post-treatment 2 hours after treatment
  • Cognitive efficiency as measured by the Mental Efficiency Workload Test (MEWT) 0-48 hours after treatment
Conditions:
  • Migraine Disorders
Keywords:
  • Migraine, acute
  • Naproxen sodium
  • Butalbital-containing Combination Medication (BCM)
  • Migraine
  • TREXIMET®
  • Sumatriptan succinate
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 65 Year
Enrollment: 220
Enrollment Type: Actual
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: No locations currently recruiting for this study.