Migraine DisordersPhase 3NCT00240630
Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
A Phase 3 study testing sumatriptan succinate/naproxen sodium in people with Migraine Disorders and Migraine, run by GlaxoSmithKline at 50 sites in United States.
Trial summary
The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders, Migraine
- 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
- 646 participants
- Where
- 50 sitesUnited States
- Study dates
- Oct 2005to Jun 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
- All sexes
- 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
50 sites in 1 country.
50 sites in 1 country
United States50 sites
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Austell, Georgia, 30106
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Braintree, Massachusetts, 02184
GSK Investigational Site
Burlington, Vermont, 05405
GSK Investigational Site
Chandler, Arizona, 85224
GSK Investigational Site
Chicago, Illinois, 60614
GSK Investigational Site
Cleveland, Ohio, 44195
GSK Investigational Site
Colorado Springs, Colorado, 80904
GSK Investigational Site
Daytona Beach, Florida, 32114
GSK Investigational Site
Endwell, New York, 13760
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Fargo, North Dakota, 58122
GSK Investigational Site
Fort Wayne, Indiana, 46805
GSK Investigational Site
Georgetown, Texas, 78626
GSK Investigational Site
Germantown, Tennessee, 38138
GSK Investigational Site
Hartford, Connecticut, 06106
GSK Investigational Site
Hollywood, Florida, 33021
GSK Investigational Site
Houston, Texas, 77004
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Irvine, California, 92618
GSK Investigational Site
Kalamazoo, Michigan, 49009
GSK Investigational Site
Las Vegas, Nevada, 89146
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Manhasset, New York, 11030
GSK Investigational Site
Manlius, New York, 13104
GSK Investigational Site
Medford, Oregon, 97504-8456
GSK Investigational Site
Milford, Massachusetts, 01757
GSK Investigational Site
Minneapolis, Minnesota, 55422
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
New York, New York, 10022
GSK Investigational Site
Newport Beach, California, 92660
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Palm Beach Gardens, Florida, 33410
GSK Investigational Site
Philadelphia, Pennsylvania, 19107-2568
GSK Investigational Site
Phoenix, Arizona, 85013
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
GSK Investigational Site
Salt Lake City, Utah, 84107
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Antonio, Texas, 78258
GSK Investigational Site
San Francisco, California, 94109
GSK Investigational Site
Santa Monica, California, 90404
GSK Investigational Site
Seattle, Washington, 98122
GSK Investigational Site
Stamford, Connecticut, 06902
GSK Investigational Site
Tulsa, Oklahoma, 74136
GSK Investigational Site
Walnut Creek, California, 94596
GSK Investigational Site
West Palm Beach, Florida, 33407
GSK Investigational Site
Westlake Village, California, 91361
GSK Investigational Site
Wichita, Kansas, 67207
About this study
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks
The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.
- Conditions
- Migraine Disorders, Migraine
- Being tested
- sumatriptan succinate/naproxen sodium, placebo
- Keywords
- acute migraine, consistency of response, satisfaction, migraine, early intervention
- Medical subject headings
- Migraine Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sumatriptan succinate/naproxen sodiumDrug
Combination Tablet of Treximet
placeboDrug
placebo to match
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | placebo to match Receives: Drug: sumatriptan succinate/naproxen sodium |
| Arm 2 | Experimental | Treximet (sumatriptan/naproxen sodium) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on a migraine pain scale for multiple migraine attacks
Measured: 2 to 24 hours
Secondary outcomes (1)
Within patient consistency of response, freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, recurrence of head pain, safety and tolerability
Measured: 2 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 646 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240630
- Sponsor's protocol ID
- TRX103632
- Status last verified
- Apr 2015
- First submitted
- 14 Oct 2005
- Last updated
- 16 Apr 2015
- Results posted
- No
Publications
Torgovnick J, Sethi NK, Arsura E. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled cross-over study. Cephalalgia. 2010 Oct;30(10):1277; author reply 1277-9. doi: 10.1177/0333102409352810. Epub 2010 May 13. No abstract available.
PubMed 20855373
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks
- ClinicalTrials.gov ID
- NCT00240630
- Acronym / sponsor ID
- TRX103632
- Conditions
- Migraine Disorders, Migraine
- Keywords
- acute migraine, consistency of response, satisfaction, migraine, early intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 646 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 18 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: sumatriptan succinate/naproxen sodiumplacebo to match |
| Arm 2 | Experimental | Drug: placeboTreximet (sumatriptan/naproxen sodium) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Pregnant and/or nursing mother.
- History of cardiovascular disease.
- Uncontrolled hypertension.
- Basilar or Hemiplegic migraine.
- History of stroke or transient ischemic attacks (TIA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sumatriptan succinate/naproxen sodiumCombination Tablet of Treximet | Drug | Arm 1 |
| placeboplacebo to match | Drug | Arm 2 |
Primary outcome
Score on a migraine pain scale for multiple migraine attacks
Time frame: 2 to 24 hours
1 secondary outcome
Within patient consistency of response, freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, recurrence of head pain, safety and tolerability
Time frame: 2 to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
- Results publication: PubMed 20855373Torgovnick J, Sethi NK, Arsura E. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled cross-over study. Cephalalgia. 2010 Oct;30(10):1277; author reply 1277-9. doi: 10.1177/0333102409352810. Epub 2010 May 13. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sumatriptan succinate/naproxen sodium in people with Migraine Disorders and Migraine, run by GlaxoSmithKline at 50 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 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 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?
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 migraine pain scale for multiple migraine attacks (time frame: 2 to 24 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 NCT00240630, 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 Apr 2015.