Migraine DisordersPhase 3NCT00382993
A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2)
A Phase 3 study testing Combination Product (sumatriptan succinate/naproxen sodium) in people with Migraine Disorders, run by GlaxoSmithKline at 28 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. 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?
- Combination Product (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
- 169 participants
- Where
- 28 sitesUnited States
- Study dates
- Dec 2006to Nov 2007
- 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
- Subject is male or female between 18 and 65 years old.
- Subject has migraine with or without aura (2004 ICHD-II criteria).
- Subject has 1-8 migraines per month over the previous 3 months and less than 15 total headache days per month.
- Subject has recently (within 1 year) discontinued the use of eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan, due to nonresponse or intolerable adverse events. Non-response is defined as documented discontinuation of treatment with eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan for reasons related to response, including (but not limited to): slow onset of efficacy, inconsistent efficacy, inadequate overall efficacy, or inadequate sustained efficacy through 24 hours. Intolerance is defined as documented discontinuation of treatment with eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan for other reasons, attributable to the triptan, outside of non-response.
- A female is eligible to enter and participate in this study if she is of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
Show all 49Show fewer
- child-bearing potential, has a negative urine pregnancy test at screen, and agrees to one of the following acceptable measures of contraception:
- Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 5 days); subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit; or,
- Female sterilization; or,
- Sterilization of male partner; or,
- Implants of levonorgestrel; or,
- Injectable progestogen; or,
- Oral contraceptive (combined or progestogen only); or,
- Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or,
- Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm); or,
- Any other methods with published data showing that the highest expected failure rate for that method is less than 1% per year; or,
- Any other barrier methods only if used in combination with any of the above acceptable methods.
- Subject taking oral contraceptives has been on a stable regimen for at least 2 months prior to screening.
- Subject is willing and able to provide informed consent prior to entry into this treatment phase of the study.
- Subject is able to understand and complete the diary card.
- Exclusion Criteria: Subjects with any of the following criteria may not enroll in the study:
- Subject has non-migraine headache, retinal migraine, basilar or hemiplegic migraine, cluster headache, or headaches secondary to trauma, cranial or cervical disorders, infections, alterations of homeostasis, ENT disorders, psychiatric disorders or cranial neuralgias.
- Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm, or signs/symptoms consistent with any of the above.
- Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome.
- Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
- Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs).
- Subject has a history of congenital heart disease.
- Subject has uncontrolled hypertension at screening (sitting systolic pressure ≥140mmHg, diastolic pressure ≥90mmHg).
- Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or the presence of risk factors including but not limited to, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age).
- Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening.
- Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
- Subject is currently taking a monoamine oxidase inhibitor (MAOI), or has taken a MAOI within 2 weeks prior to screening or plans to take within 2 weeks after treatment.
- Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a medication that is not stabilized (i.e. change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized..
- Subject is currently taking any anti-coagulant (e.g., warfarin).
- Subject has a recent history of regular use of opioids or barbiturates for treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months.
- Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John's Wort (Hypericum perforatum).
- Subject has hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of their components or any other 5-HT1 receptor agonist.
- Subject has a history of allergic reactions to naproxen preparations, including subject in whom aspirin or other NSAID drugs induce the syndrome of asthma, rhinitis, and nasal polyps.
- Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
- Subject has a history of gastric bypass or stapling surgery.
- Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year.
- Subject has a history of inflammatory bowel disease.
- Subject has a history of any bleeding disorder.
- Subject is taking any antiplatelet agent (except low-dose aspirin ≤ 325mg/day for cardioprotective reasons).
- Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
- Subject is pregnant, actively trying to become pregnant or breast-feeding.
- Subject has evidence of alcohol or substance abuse within the last year which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results.
- Subject has any concurrent medical or psychiatric condition which, in the investigator's opinion, may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in this clinical trial.
- Subject has participated in an investigational drug trial within the previous four weeks or plans to participate in another study at any time during this study.
Who cannot join
None listed.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
GSK Investigational Site
Allentown, Pennsylvania, 18103
GSK Investigational Site
Ann Arbor, Michigan, 48104
GSK Investigational Site
Augusta, Georgia, 30901
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Charleston, South Carolina, 29412
GSK Investigational Site
Dallas, Texas, 75231
GSK Investigational Site
Des Moines, Iowa, 50314
GSK Investigational Site
Hartford, Connecticut, 06106
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Memphis, Tennessee, 38018
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
Northbrook, Illinois, 60062
GSK Investigational Site
Oceanside, California, 92056
GSK Investigational Site
Omaha, Nebraska, 68114
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Pikesville, Maryland, 21208
GSK Investigational Site
San Antonio, Texas, 78258
GSK Investigational Site
San Francisco, California, 94109
GSK Investigational Site
Savannah, Georgia, 31405
GSK Investigational Site
Seattle, Washington, 98104
GSK Investigational Site
Shreveport, Louisiana, 71103
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Stratford, New Jersey, 08084
GSK Investigational Site
Toledo, Ohio, 43614-5809
GSK Investigational Site
Westerville, Ohio, 43081
GSK Investigational Site
Williamsville, New York, 14221
GSK Investigational Site
Worcester, Massachusetts, 01605
About this study
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). [Study 2 of 2]
Read the detailed description
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design); however, the order of these treatments will be randomized. A minimum 1-week washout period is required between study medication treatment of the first and second migraine attacks.
Each subject will have two visits: (1) a Screening visit at study entry and (2) a Final visit 4-10 days after the second (or last) attack. A telephone contact will also be required 1-3 days after the first attack, and then once per month until the Final visit.
The primary study objective is to assess efficacy as measured by sustained pain-free (SPF) relief of Combination Product compared to placebo in treating migraine subjects who have previously discontinued treatment with short acting triptans (rizatriptan, sumatriptan, almotriptan, zolmitriptan, and eletriptan).
- Conditions
- Migraine Disorders
- Being tested
- Placebo, Combination Product (sumatriptan succinate/naproxen sodium)
- Keywords
- migraine with or without aura, naproxen sodium, combination product, sumatriptan succinate, poor response, short acting triptan, migraine, acute
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching placebo tablet
Combination Product (sumatriptan succinate/naproxen sodium)Drug
Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in second layer.
| Study group | Role | What they receive |
|---|---|---|
| Combination Product - Placebo | Other | Combination Product (sumatriptan and naproxen sodium) [Attack 1] followed by Placebo [Attack 2] Receives: Drug: Placebo; Drug: Combination Product (sumatriptan succinate/naproxen sodium) |
| Placebo - Combination Product | Other | Placebo [Attack 1] followed by Combination Product (sumatriptan and naproxen sodium) [Attack 2] Receives: Drug: Placebo; Drug: Combination Product (sumatriptan succinate/naproxen sodium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose
Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.
Measured: 2 - 24 Hours Post-Dose
Secondary outcomes (18)
Migraine Headache Pain Free at 2 Hours Post-Dose
Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.
Measured: 2 Hours Post-Dose
Rescue Medication Use During 0 - 24 Hours Post-Dose
A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label).
Measured: 0-24 Hours Post-Dose
Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose
Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.
Measured: 0.5, 1, 4, and 8 Hours Post-Dose
Sustained Freedom From Migraine
Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication.
Measured: 2 - 24 hours post-dose
Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose
Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment.
Measured: 2, 4 , and 8 hours post-dose
Sustained Freedom From Migraine-Associated Sinus Pain
Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.
Measured: 2 - 24 hours post-dose
Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who had sinus pain at the time of assessment.
Measured: Baseline, 2, 4, and 8 hours post-dose
Sustained Freedom From Migraine-Associated Neck Pain
Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.
Measured: 2 - 24 hours post-dose
Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of Participants with neck pain at the time of assessment.
Measured: Baseline, 2, 4, and 8 hours post-dose
Sustained Freedom From Migraine-Associated Photophobia
Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.
Measured: 2 - 24 hours post-dose
Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who had photophobia (sensitivity to light) at the time of assessment.
Measured: Baseline, 2, 4, and 8 hours post-dose
Sustained Freedom From Migraine-Associated Phonophobia
Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.
Measured: 2 - 24 hours post-dose
Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.
Measured: Baseline, 2, 4, and 8 hours post-dose
Sustained Freedom From Migraine-Associated Nausea
Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.
Measured: 2 - 24 hours post-dose
Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present.
Measured: Baseline, 2, 4, and 8 hours
Sustained Complete Pain/Symptom-Free
Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication.
Measured: 2 - 24 hours post-dose
Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment. "Complete pain/symptom-free" was defined as migraine-free, neck pain-free, and sinus pain free.
Measured: Baseline, 2, 4, and 8 hours post-dose
Recurrence of Any Migraine Headache Pain
Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours.
Measured: 24 hours and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startDec 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- 169 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
- NCT00382993
- Sponsor's protocol ID
- TRX106573
- Status last verified
- Dec 2016
- First submitted
- 29 Sep 2006
- Last updated
- 2 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Mathew N, Landy S, Tietjen G, Stark S, Runken M, Lener S, Derosier F, and Bukenya D. Evaluation of a single fixed-dose tablet of Sumatriptan 85 mg formulated with RT Technology/Naproxen sodium 500 mg (SumaRT/Nap) in Subjects who Reported Poor Response or Intolerance to Short Acting Triptans for the Acute Treatment of Migraine. Headache 2008: S44-45.
Mathew NT, Landy S, Stark S, Tietjen GE, Derosier FJ, White J, Lener SE, Bukenya D. Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache. 2009 Jul;49(7):971-82. doi: 10.1111/j.1526-4610.2009.01458.x. Epub 2009 May 27.
PubMed 19486178
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2)
- ClinicalTrials.gov ID
- NCT00382993
- Acronym / sponsor ID
- TRX106573
- Conditions
- Migraine Disorders
- Keywords
- migraine with or without aura, naproxen sodium, combination product, sumatriptan succinate, poor response, short acting triptan, migraine, acute
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 2 Oct 2006 (estimated)
- Results
- Posted 20 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). [Study 2 of 2]
Detailed description
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design); however, the order of these treatments will be randomized. A minimum 1-week washout period is required between study medication treatment of the first and second migraine attacks.
Each subject will have two visits: (1) a Screening visit at study entry and (2) a Final visit 4-10 days after the second (or last) attack. A telephone contact will also be required 1-3 days after the first attack, and then once per month until the Final visit.
The primary study objective is to assess efficacy as measured by sustained pain-free (SPF) relief of Combination Product compared to placebo in treating migraine subjects who have previously discontinued treatment with short acting triptans (rizatriptan, sumatriptan, almotriptan, zolmitriptan, and eletriptan).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Product - Placebo | Other | Drug: Placebo, Drug: Combination Product (sumatriptan succinate/naproxen sodium)Combination Product (sumatriptan and naproxen sodium) [Attack 1] followed by Placebo [Attack 2] |
| Placebo - Combination Product | Other | Drug: Placebo, Drug: Combination Product (sumatriptan succinate/naproxen sodium)Placebo [Attack 1] followed by Combination Product (sumatriptan and naproxen sodium) [Attack 2] |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (49 listed)
- Subject is male or female between 18 and 65 years old.
- Subject has migraine with or without aura (2004 ICHD-II criteria).
- Subject has 1-8 migraines per month over the previous 3 months and less than 15 total headache days per month.
- Subject has recently (within 1 year) discontinued the use of eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan, due to nonresponse or intolerable adverse events. Non-response is defined as documented discontinuation of treatment with eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan for reasons related to response, including (but not limited to): slow onset of efficacy, inconsistent efficacy, inadequate overall efficacy, or inadequate sustained efficacy through 24 hours. Intolerance is defined as documented discontinuation of treatment with eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan for other reasons, attributable to the triptan, outside of non-response.
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PlaceboMatching placebo tablet | Drug | Combination Product - Placebo, Placebo - Combination Product |
| Combination Product (sumatriptan succinate/naproxen sodium)Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in second layer. | Drug | Combination Product - Placebo, Placebo - Combination Product |
Primary outcome
Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose
Time frame: 2 - 24 Hours Post-Dose
Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.
18 secondary outcomes
Migraine Headache Pain Free at 2 Hours Post-Dose
Time frame: 2 Hours Post-Dose
Rescue Medication Use During 0 - 24 Hours Post-Dose
Time frame: 0-24 Hours Post-Dose
Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose
Time frame: 0.5, 1, 4, and 8 Hours Post-Dose
Sustained Freedom From Migraine
Time frame: 2 - 24 hours post-dose
Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose
Time frame: 2, 4 , and 8 hours post-dose
Sustained Freedom From Migraine-Associated Sinus Pain
Time frame: 2 - 24 hours post-dose
Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Time frame: Baseline, 2, 4, and 8 hours post-dose
Sustained Freedom From Migraine-Associated Neck Pain
Time frame: 2 - 24 hours post-dose
Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Time frame: Baseline, 2, 4, and 8 hours post-dose
Sustained Freedom From Migraine-Associated Photophobia
Time frame: 2 - 24 hours post-dose
Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Time frame: Baseline, 2, 4, and 8 hours post-dose
Sustained Freedom From Migraine-Associated Phonophobia
Time frame: 2 - 24 hours post-dose
Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Time frame: Baseline, 2, 4, and 8 hours post-dose
Sustained Freedom From Migraine-Associated Nausea
Time frame: 2 - 24 hours post-dose
Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Time frame: Baseline, 2, 4, and 8 hours
Sustained Complete Pain/Symptom-Free
Time frame: 2 - 24 hours post-dose
Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Time frame: Baseline, 2, 4, and 8 hours post-dose
Recurrence of Any Migraine Headache Pain
Time frame: 24 hours and 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundMathew N, Landy S, Tietjen G, Stark S, Runken M, Lener S, Derosier F, and Bukenya D. Evaluation of a single fixed-dose tablet of Sumatriptan 85 mg formulated with RT Technology/Naproxen sodium 500 mg (SumaRT/Nap) in Subjects who Reported Poor Response or Intolerance to Short Acting Triptans for the Acute Treatment of Migraine. Headache 2008: S44-45.
- Background: PubMed 19486178Mathew NT, Landy S, Stark S, Tietjen GE, Derosier FJ, White J, Lener SE, Bukenya D. Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache. 2009 Jul;49(7):971-82. doi: 10.1111/j.1526-4610.2009.01458.x. Epub 2009 May 27.
- 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
28 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 Combination Product (sumatriptan succinate/naproxen sodium) in people with Migraine Disorders, run by GlaxoSmithKline at 28 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 49 inclusion and 0 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
Yes. Results are posted in the registry (first posted 20 Apr 2010). 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?
Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose (time frame: 2 - 24 Hours Post-Dose). 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 NCT00382993, which also lists 2 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 2 Feb 2017.