Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)
A Randomized, Double-blind, Single Migraine Attack, Placebo-controlled, Parallel-group Multicenter Study to Evaluate the Efficacy and Tolerability of 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
351
1 country
35
Brief Summary
This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as 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
35 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
CompletedJanuary 23, 2017
January 1, 2017
6 months
May 22, 2006
January 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score on a 4-pt 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
2 to 48 hours
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 (35)
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Irvine, California, 92618, United States
GSK Investigational Site
Redondo Beach, California, 90277, United States
GSK Investigational Site
San Francisco, California, 94109, United States
GSK Investigational Site
Santa Monica, California, 90404, United States
GSK Investigational Site
Boulder, Colorado, 80304, United States
GSK Investigational Site
Colorado Springs, Colorado, 80909, United States
GSK Investigational Site
Port Orange, Florida, 32127, United States
GSK Investigational Site
Sunrise, Florida, 33351, United States
GSK Investigational Site
West Palm Beach, Florida, 33407, United States
GSK Investigational Site
Chicago, Illinois, 60614, United States
GSK Investigational Site
South Bend, Indiana, 46601, United States
GSK Investigational Site
Baton Rouge, Louisiana, 70808, United States
GSK Investigational Site
Ann Arbor, Michigan, 48104, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
New York, New York, 10022, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cincinnati, Ohio, 45245, United States
GSK Investigational Site
Cincinnati, Ohio, 45267, United States
GSK Investigational Site
Toledo, Ohio, 43614-5809, United States
GSK Investigational Site
West Chester, Ohio, 45069, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Carnegie, Pennsylvania, 15106, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19114, United States
GSK Investigational Site
Warwick, Rhode Island, 02886, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Georgetown, Texas, 78626, United States
GSK Investigational Site
Houston, Texas, 77054, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Seattle, Washington, 98195, 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
January 23, 2017
Record last verified: 2017-01
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.