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Migraine, Without AuraPhase 3NCT00387881

TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)

A Phase 3 study testing sumatriptan succinate / naproxen sodium in people with Migraine, Without Aura, run by GlaxoSmithKline at 70 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 the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine, Without Aura
What is being tested?
sumatriptan succinate / naproxen sodium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
679 participants
Where
70 sitesUnited States
Study dates
Sep 2006to Feb 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least a 6 month history of probably migraine (6 migraine attacks per month)
  • Males and women of childbearing potential on a adequate contraception.

Who cannot join

  • Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use
  • Pregnant and/or nursing mother
  • History of cardiovascular disease.
  • Uncontrolled hypertension.
  • Basilar or Hemiplegic migraine
  • History of stroke or transient ischemic attacks (TIA).
Show all 12Show fewer
  • History of epilepsy or treated with anti-epileptics within the 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.

Trial locations and contacts

70 sites in 1 country.

70 sites in 1 country

United States70 sites

  • GSK Investigational Site

    Albany, New York, 12206

  • GSK Investigational Site

    Albuquerque, New Mexico, 87108

  • GSK Investigational Site

    Alexandria, Virginia, 22311

  • GSK Investigational Site

    Anaheim, California, 92801

  • GSK Investigational Site

    Anaheim, California, 92805

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Ann Arbor, Michigan, 48104

  • GSK Investigational Site

    Atlanta, Georgia, 30033

  • GSK Investigational Site

    Atlanta, Georgia, 30308

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Austin, Texas, 78745

  • GSK Investigational Site

    Bellaire, Texas, 77401

  • GSK Investigational Site

    Buena Park, California, 90620

  • GSK Investigational Site

    Carnegie, Pennsylvania, 15106

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599

  • GSK Investigational Site

    Chicago, Illinois, 60614

  • GSK Investigational Site

    Cincinnati, Ohio, 45245

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Colorado Springs, Colorado, 80904

  • GSK Investigational Site

    Diamond Bar, California, 91765

  • GSK Investigational Site

    Evansville, Indiana, 47712

  • GSK Investigational Site

    Greensboro, North Carolina, 27401

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Independence, Ohio, 44131

  • GSK Investigational Site

    Kalamazoo, Michigan, 49009

  • GSK Investigational Site

    Katy, Texas, 77450

  • GSK Investigational Site

    Las Vegas, Nevada, 89146

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Medford, Oregon, 97504-8456

  • GSK Investigational Site

    Miami, Florida, 331144

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53209-0996

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New Orleans, Louisiana, 70121

  • GSK Investigational Site

    New York, New York, 10022

  • GSK Investigational Site

    Newport Beach, California, 92660

  • GSK Investigational Site

    North Dartmouth, Massachusetts, 02747

  • GSK Investigational Site

    Pembroke Pines, Florida, 33024

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107-2568

  • GSK Investigational Site

    Phoenix, Arizona, 85014

  • GSK Investigational Site

    Phoenix, Arizona, 85050

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15236

  • GSK Investigational Site

    Raleigh, North Carolina, 27609

  • GSK Investigational Site

    Richardson, Texas, 75080

  • GSK Investigational Site

    Rochester, New York, 14642

  • GSK Investigational Site

    Saint Louis Park, Minnesota, 55426

  • GSK Investigational Site

    Salt Lake City, Utah, 84107

  • GSK Investigational Site

    Salt Lake City, Utah, 84109

  • GSK Investigational Site

    Salt Lake City, Utah, 84121

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92128

  • GSK Investigational Site

    San Francisco, California, 94109

  • GSK Investigational Site

    Santa Monica, California, 90404

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    Seattle, Washington, 98195

  • GSK Investigational Site

    Simpsonville, South Carolina, 29681

  • GSK Investigational Site

    Springfield, Missouri, 65804

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Stamford, Connecticut, 06902

  • GSK Investigational Site

    The Bronx, New York, 10461

  • GSK Investigational Site

    Valley Stream, New York, 11580

  • GSK Investigational Site

    Walnut Creek, California, 94596

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    West Chester, Ohio, 45069

  • GSK Investigational Site

    West Jordan, Utah, 84084

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

  • GSK Investigational Site

    Westerville, Ohio, 43081

  • GSK Investigational Site

    Westlake Village, California, 91361

  • GSK Investigational Site

    Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of TREXIMA* (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1) (*TREXIMET)

This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.

Being tested
sumatriptan succinate / naproxen sodium, Placebo
Keywords
sumatriptan succinate,, naproxen sodium,, parallel group,, double-blind,, placebo-controlled,, Combination product,, migrainous headache, Probable migraine, a sub-type of Migraine, probable migraine,
Medical subject headings
Migraine without Aura, Migraine Disorders

What participants receive

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

  • sumatriptan succinate / naproxen sodiumDrug

    sumatriptan 85mg / naproxen sodium 500mg

  • PlaceboDrug

    Placebo to match Treximet tablets

Study groups in NCT00387881
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
TreximetExperimentalNot described
Receives: Drug: sumatriptan succinate / naproxen sodium

What is being measured

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

  1. Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.

    Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.

    Measured: 2 hours through 24 hours after Treatment

Secondary outcomes (8)

  1. Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment

    Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment.

    Measured: 0.5, 1, and 4 hours after Treatment

  2. Sustained Headache Relief 2-24 Hours After Treatment

    Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication.

    Measured: 2-24 hours after treatment

  3. Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment

    Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time.

    Measured: 0.5, 1, 2, and 4 hours after treatment

  4. Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment

    Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack.

    Measured: 0 - 24 hours after treatment

  5. Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment

    Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.)

    Measured: 1-2, and 2- 4 hours after treatment

  6. Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours

    Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.)

    Measured: 1-2 and 2-4 hours after treatment

  7. Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment

    Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.)

    Measured: 2 and 4 hours after treatment

  8. Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score

    Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction.

    Measured: 0 - 24 hours after treatment

Timeline

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

  1. First posted13 Oct 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

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
679 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00387881
Sponsor's protocol ID
TXA107563
Status last verified
Nov 2016
First submitted
11 Oct 2006
Last updated
16 Dec 2016
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

  • Silberstein S, Lipton RB, Goldstein J, Aurora SK, White J, Ochs-Ross R, Lener SE, McDonald SA. Evaluation of a New Fixed-dose Single Tablet of Sumatriptan Formulated with RT Technology and Naproxen Sodium (SumaRT/Nap) for the Acute Treatment of Probable Migraine without Aura. Headache 2008: presented at the American Headache Society Meeting, Boston, MA.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sumatriptan succinate / naproxen sodium in people with Migraine, Without Aura, run by GlaxoSmithKline at 70 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 2 inclusion and 12 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 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 10 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. (time frame: 2 hours through 24 hours after Treatment). 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 NCT00387881, which also lists 1 linked publication.

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 16 Dec 2016.

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