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

NCT ID: NCT00329459

Last Updated: 2016-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-11-30

Brief Summary

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

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Detailed Description

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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)

Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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arm 1

Treximet (sumatriptan/naproxen sodium)

Group Type EXPERIMENTAL

sumatriptan succinate/naproxen sodium

Intervention Type DRUG

arm 2

placebo to match

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo to match

Interventions

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sumatriptan succinate/naproxen sodium

Intervention Type DRUG

placebo

placebo to match

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Mesa, Arizona, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

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Fair Oaks, California, United States

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Newport Beach, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Stamford, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Wichita, Kansas, United States

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Milford, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Detroit, Michigan, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Moorestown, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Plainview, New York, United States

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Rochester, New York, United States

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Greensboro, North Carolina, United States

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Cleveland, Ohio, United States

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Independence, Ohio, United States

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Westerville, Ohio, United States

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Eugene, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Greer, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Fort Worth, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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GSK Investigational Site

Wenatchee, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20353434 (View on PubMed)

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):106-113. doi: 10.1097/AOG.0b013e3181a98e4d.

Reference Type RESULT
PMID: 19546766 (View on PubMed)

Martin 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.

Reference Type DERIVED
PMID: 24579886 (View on PubMed)

Cady 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.

Reference Type DERIVED
PMID: 21521204 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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TRX105850

Identifier Type: -

Identifier Source: org_study_id

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