Migraine DisordersPhase 3NCT00240617
Study Of Treximet, 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, run by GlaxoSmithKline at 52 sites in United States.
Trial summary
The purpose of this study is to determine the consistency of response for Treximet (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
- What is being tested?
- sumatriptan succinate/naproxen sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 623 participants
- Where
- 52 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.
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- 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
52 sites in 1 country.
52 sites in 1 country
United States52 sites
GSK Investigational Site
Albany, New York, 12206
GSK Investigational Site
Albuquerque, New Mexico, 87108
GSK Investigational Site
Anderson, South Carolina, 29621
GSK Investigational Site
Ann Arbor, Michigan, 48104
GSK Investigational Site
Anniston, Alabama, 36207
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Avon, Connecticut, 06001
GSK Investigational Site
Baton Rouge, Louisiana, 70808
GSK Investigational Site
Boulder, Colorado, 80304
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Chapel Hill, North Carolina, 27599
GSK Investigational Site
Chicago, Illinois, 60607
GSK Investigational Site
Clarksville, Tennessee, 37043
GSK Investigational Site
Concinnati, Ohio, 45219
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Evansville, Indiana, 47712
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Greensboro, North Carolina, 27401
GSK Investigational Site
Hot Springs, Arkansas, 71913
GSK Investigational Site
Irvine, California, 92618
GSK Investigational Site
Memphis, Tennessee, 38105
GSK Investigational Site
Mesa, Arizona, 85201
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Moorestown, New Jersey, 08057
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Oceanside, California, 92056
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Philadelphia, Pennsylvania, 19114
GSK Investigational Site
Phoenix, Arizona, 85032
GSK Investigational Site
Plainview, New York, 11803
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
Rome, Georgia, 30165
GSK Investigational Site
Saint Louis Park, Minnesota, 55426
GSK Investigational Site
Salem, Oregon, 97301
GSK Investigational Site
Salt Lake City, Utah, 84121
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92108
GSK Investigational Site
San Diego, California, 92128
GSK Investigational Site
Seattle, Washington, 98195
GSK Investigational Site
South Daytona, Florida, 32119
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Stuart, Florida, 34996
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
The Bronx, New York, 10467
GSK Investigational Site
Tuscaloosa, Alabama, 35406
GSK Investigational Site
Valley Stream, New York, 11580
GSK Investigational Site
Wenatchee, Washington, 98801
GSK Investigational Site
West Chester, Ohio, 45069
GSK Investigational Site
Westerville, Ohio, 43081
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 (*Treximet)
The purpose of this study is to determine the consistency of response for Treximet (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
- Being tested
- sumatriptan succinate/naproxen sodium, placebo
- Keywords
- consistency of response, migraine, satisfaction, 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
comparator
placeboDrug
placebo to match
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Active comparator | Treximet (sumatriptan/naproxen sodium) formerly known as TREXIMA Receives: Drug: sumatriptan succinate/naproxen sodium |
| arm 2 | Placebo comparator | placebo to match Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on a 4 pt 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
- 623 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
- NCT00240617
- Sponsor's protocol ID
- TRX103635
- Status last verified
- Oct 2016
- First submitted
- 14 Oct 2005
- Last updated
- 26 Oct 2016
- 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
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 26 Oct 2016. 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 (*Treximet)
- ClinicalTrials.gov ID
- NCT00240617
- Acronym / sponsor ID
- TRX103635
- Conditions
- Migraine Disorders
- Keywords
- consistency of response, migraine, satisfaction, early intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 623 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 (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 | Active comparator | Drug: sumatriptan succinate/naproxen sodiumTreximet (sumatriptan/naproxen sodium) formerly known as TREXIMA |
| arm 2 | Placebo comparator | Drug: placeboplacebo to match |
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 sodiumcomparator | Drug | arm 1 |
| placeboplacebo to match | Drug | arm 2 |
Primary outcome
Score on a 4 pt 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 26 Oct 2016.
- 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
52 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, run by GlaxoSmithKline at 52 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 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 4 pt 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 NCT00240617, 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 26 Oct 2016.