Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea
A Randomized, Double-blind, Single Migraine Attack, Placebo -Controlled, Patallel-group Multicenter Study to Evaluate the Efficacy and Tolerability or Trexima (Sumatriptan Succinate/Naproxen Sodium) Tablets vs Placebo When Administered During the Mild Pain Phase of Menstrual Migraine in Women With Dysmenorrhea
1 other identifier
interventional
320
1 country
34
Brief Summary
This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2006
Shorter than P25 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 22, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedOctober 24, 2016
October 1, 2016
6 months
May 22, 2006
October 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score on a 4-point migraine pain scale for a single menstrual migraine attack
2 to 48 hours
Secondary Outcomes (1)
Freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, menstrual symptoms, recurrence of head pain, safety and tolerability
from 2 to 48 hours
Study Arms (2)
arm 1
EXPERIMENTALTreximet (sumatriptan/naproxen sodium)
arm 2
PLACEBO COMPARATORplacebo to match
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (34)
GSK Investigational Site
Mesa, Arizona, 85201, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Fair Oaks, California, 95628, United States
GSK Investigational Site
Newport Beach, California, 92660, United States
GSK Investigational Site
San Diego, California, 92128, United States
GSK Investigational Site
San Francisco, California, 94102, United States
GSK Investigational Site
Stamford, Connecticut, 06902, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33328, United States
GSK Investigational Site
Miami, Florida, 33173, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Milford, Massachusetts, 01757, United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747, United States
GSK Investigational Site
Detroit, Michigan, 48201, United States
GSK Investigational Site
Springfield, Missouri, 65804, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Moorestown, New Jersey, 08057, United States
GSK Investigational Site
Albuquerque, New Mexico, 87102, United States
GSK Investigational Site
Albany, New York, 12206, United States
GSK Investigational Site
Plainview, New York, 11803, United States
GSK Investigational Site
Rochester, New York, 14609, United States
GSK Investigational Site
Greensboro, North Carolina, 27401, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Independence, Ohio, 44131, United States
GSK Investigational Site
Westerville, Ohio, 43081, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Memphis, Tennessee, 38018, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
Related Publications (4)
Durham PL, Vause CV, Derosier F, McDonald S, Cady R, Martin V. Changes in salivary prostaglandin levels during menstrual migraine with associated dysmenorrhea. Headache. 2010 May;50(5):844-51. doi: 10.1111/j.1526-4610.2010.01657.x. Epub 2010 Mar 26.
PMID: 20353434RESULTMannix LK, Martin VT, Cady RK, Diamond ML, Lener SE, White JD, Derosier FJ, McDonald SA. Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials. Obstet Gynecol. 2009 Jul;114(1):106-113. doi: 10.1097/AOG.0b013e3181a98e4d.
PMID: 19546766RESULTMartin VT, Ballard J, Diamond MP, Mannix LK, Derosier FJ, Lener SE, Krishen A, McDonald SA. Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium. J Womens Health (Larchmt). 2014 May;23(5):389-96. doi: 10.1089/jwh.2013.4577. Epub 2014 Feb 28.
PMID: 24579886DERIVEDCady RK, Diamond ML, Diamond MP, Ballard JE, Lener ME, Dorner DP, Derosier FJ, McDonald SA, White J, Runken MC. Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes. Headache. 2011 May;51(5):664-73. doi: 10.1111/j.1526-4610.2011.01894.x.
PMID: 21521204DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2006
First Posted
May 24, 2006
Study Start
May 1, 2006
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
October 24, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.