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

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ClinicalTrials.gov Identifier: NCT00387881
Recruitment Status : Completed
First Posted : October 13, 2006
Results First Posted : July 10, 2009
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE October 11, 2006
First Posted Date  ICMJE October 13, 2006
Results First Submitted Date  ICMJE February 19, 2009
Results First Posted Date  ICMJE July 10, 2009
Last Update Posted Date December 16, 2016
Study Start Date  ICMJE September 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2010)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2006)
Score on a migraine pain scale at 2 hours through 24 hours for a single probable migraine attack.
Change History Complete list of historical versions of study NCT00387881 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2010)
  • Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment [ Time Frame: 0.5, 1, and 4 hours after Treatment ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2006)
Freedom from all migraine pain and symptoms, satisfaction, recurrence of head pain, safety and tolerability.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine, Without Aura
Intervention  ICMJE
  • Drug: sumatriptan succinate / naproxen sodium
    sumatriptan 85mg / naproxen sodium 500mg
  • Drug: Placebo
    Placebo to match Treximet tablets
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Treximet
    Intervention: Drug: sumatriptan succinate / naproxen sodium
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2009)
679
Original Enrollment  ICMJE
 (submitted: October 12, 2006)
20
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00387881
Other Study ID Numbers  ICMJE TXA107563
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP