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MigrainePhase 3NCT00329355

Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

A Phase 3 study testing sumatriptan succinate/naproxen sodium in people with Migraine and Migraine Disorders, run by GlaxoSmithKline at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Migraine, Migraine Disorders
What is being tested?
sumatriptan succinate/naproxen sodium
How many people
351 participants
Where
35 sitesUnited States
Study dates
May 2006to Nov 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87108

  • GSK Investigational Site

    Ann Arbor, Michigan, 48104

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70808

  • GSK Investigational Site

    Boulder, Colorado, 80304

  • GSK Investigational Site

    Carnegie, Pennsylvania, 15106

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Chicago, Illinois, 60614

  • GSK Investigational Site

    Cincinnati, Ohio, 45245

  • GSK Investigational Site

    Cincinnati, Ohio, 45267

  • GSK Investigational Site

    Colorado Springs, Colorado, 80909

  • GSK Investigational Site

    Georgetown, Texas, 78626

  • GSK Investigational Site

    Houston, Texas, 77054

  • GSK Investigational Site

    Irvine, California, 92618

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New York, New York, 10021

  • GSK Investigational Site

    New York, New York, 10022

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19114

  • GSK Investigational Site

    Port Orange, Florida, 32127

  • GSK Investigational Site

    Portland, Oregon, 97210

  • GSK Investigational Site

    Redondo Beach, California, 90277

  • GSK Investigational Site

    Salt Lake City, Utah, 84109

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Francisco, California, 94109

  • GSK Investigational Site

    Santa Monica, California, 90404

  • GSK Investigational Site

    Seattle, Washington, 98195

  • GSK Investigational Site

    South Bend, Indiana, 46601

  • GSK Investigational Site

    Sunrise, Florida, 33351

  • GSK Investigational Site

    Toledo, Ohio, 43614-5809

  • GSK Investigational Site

    Warwick, Rhode Island, 02886

  • GSK Investigational Site

    West Chester, Ohio, 45069

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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

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.

Read the detailed 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)

Being tested
sumatriptan succinate/naproxen sodium
Keywords
menstrual migraine, headache, early intervention, dysmenorrhea
Medical subject headings
Migraine Disorders, Headache, Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sumatriptan succinate/naproxen sodiumDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score on a 4-pt migraine pain scale for a single menstrual migraine attack

    Measured: 2 to 48 hours

Secondary outcomes (1)

  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

    Measured: 2 to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionNov 2006
  4. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00329355
Sponsor's protocol ID
TRX105852
Status last verified
Jan 2017
First submitted
22 May 2006
Last updated
23 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 20353434

  • 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.

    PubMed 19546766

  • 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.

    PubMed 24579886

  • 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.

    PubMed 21521204

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sumatriptan succinate/naproxen sodium in people with Migraine and Migraine Disorders, run by GlaxoSmithKline at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score on a 4-pt migraine pain scale for a single menstrual migraine attack (time frame: 2 to 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00329355, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.

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