Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea

Migraine Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329459
• Other study ID #: TRX105850
• Status: Completed
• Phase: Phase 3
• First received: May 22, 2006
• Last updated: October 20, 2016
• Start date: May 2006
• Est. completion date: November 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.

Description:

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. (TREXIMET was formerly known as TREXIMA)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Migraine Disorders
• Premenstrual Syndrome

Intervention

Drug:
• sumatriptan succinate/naproxen sodium

• placebo
placebo to match

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Fair Oaks	California
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Independence	Ohio
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Milford	Massachusetts
United States	GSK Investigational Site	Moorestown	New Jersey
United States	GSK Investigational Site	Newport Beach	California
United States	GSK Investigational Site	North Dartmouth	Massachusetts
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plainview	New York
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Stamford	Connecticut
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	Westerville	Ohio
United States	GSK Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Mannix 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):106-13. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on a 4-point migraine pain scale for a single menstrual migraine attack		2 to 48 hours	No
Secondary	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	No

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.