Migraine Treatment Satisfaction With Treximet Versus Concomitant 2 Aleve and Imitrex
NCT ID: NCT01450995
Last Updated: 2011-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2009-12-31
2011-05-31
Brief Summary
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Detailed Description
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Triptan medications are currently thought to be safe and effective for acute migraine treatment. Treximet(tm) is a triptan tablet containing a combination of sumatriptan 85mg (Imitrex) and naproxen sodium 500 mg.
This combination has two methods of action for relieving a migraine headache. It targets the nerves and blood vessels involved in a migraine, and relieves inflammation that may cause migraine pain. Treximet(tm), is approved by the Food and Drug Administration.
The purpose of this research study is to compare the effectiveness of taking Treximet(tm) as a combination pill to taking two Aleve(r) tablets and 100mg of Imitrex(r) as separate tablets taken at the same time.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treximet
Treximet
Tablet form, one tablet dose, one tablet at migraine onset with second tablet for persistent or recurring migraine two hours after first dose.
Imitrex and Aleve
Imitrex and two Aleve
Imitrex tablet, one tablet dose, Aleve tablets, 2 220 mg tablet dose. Three tablets taken concurrently with migraine onset. Second dose of tablets may be taken if migraine persists for two hours
Interventions
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Treximet
Tablet form, one tablet dose, one tablet at migraine onset with second tablet for persistent or recurring migraine two hours after first dose.
Imitrex and two Aleve
Imitrex tablet, one tablet dose, Aleve tablets, 2 220 mg tablet dose. Three tablets taken concurrently with migraine onset. Second dose of tablets may be taken if migraine persists for two hours
Eligibility Criteria
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Inclusion Criteria
1. Subject is male or female.
2. Subject is age 18 to 65.
3. A female is eligible to enter and participate in this study if she is not breast feeding and is of: non-childbearing potential (i.e. physiologically incapable of becoming pregnant) or child-bearing potential, has a negative urine pregnancy test at screening and agrees to use an acceptable method of contraception during the course of the study 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) meet this criterion; or Double barrier method; or Any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year
4. Subject has a diagnosis of migraine and meets IHS criteria for migraine with or without aura (1.1) or migraine with aura (1.2)
5. Subject has at least a 1-year history of migraine with 2-6 migraines per month in the three months prior to screening
6. Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.
7. Subject is able to read, understand and complete diaries, subject questionnaires and the instructions for the study.
8. Subject is able and willing to give written informed consent to participate in the study.
Exclusion Criteria
1. Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina, or signs/symptoms consistent with any of the above.
2. Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome.
3. Subject has cardiac arrhythmias requiring medication or a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
4. Subject has a history of cerebrovascular pathology including stroke.
5. Subject has a history of congenital heart disease.
6. Subject has uncontrolled hypertension at screening (sitting (\>140 mmHg systolic pressure or \>90mmHg diastolic pressure).
7. Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease.
8. Subject has significant peripheral vascular disease
9. Subject is currently taking any anti-coagulant (e.g., Coumadin®).
10. Subject has a history of inflammatory bowel disease.
11. Subject has a history of any bleeding disorder.
12. Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year.
13. Subject is taking any antiplatelet agent (except low-dose aspiring ≤ 325 mg/day for cardioprotective reasons).
14. Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
15. Subject has a history of epilepsy.
16. Subject has basilar migraine, hemiplegic migraine or cluster headache.
17. Subject has impaired renal, hepatic, of any gastrointestinal surgery, gastrointestinal obstruction or perforation.
18. Subject who is currently taking monoamine oxidase inhibitor drugs (MAOIs), or has taken any MAOI within 2 weeks prior to screening.
19. Subject is pregnant, actively trying to become pregnant or breast-feeding.
20. Subject has ≥ 15 headache days in any of the three previous months prior to screening.
21. Subject is of childbearing potential and not using adequate contraceptive measures.
22. Subject has evidence of a rebound headache pattern caused by ergotamines or analgesics in the past three months.
23. 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.
24. Subject has any concurrent medical condition which may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in this clinical trial.
25. 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
18 Years
65 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Stephen H. Landy, M.D.
OTHER
Responsible Party
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Stephen H. Landy, M.D.
Sponsor
Principal Investigators
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Stephen H Landy, M.D.
Role: PRINCIPAL_INVESTIGATOR
Wesley Headache Clinic
Locations
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Wesley Headache Clinic
Memphis, Tennessee, United States
Countries
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References
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Revicki DA, Kimel M, Beusterien K, Kwong JW, Varner JA, Ames MH, Mahajan S, Cady RK. Validation of the revised Patient Perception of Migraine Questionnaire: measuring satisfaction with acute migraine treatment. Headache. 2006 Feb;46(2):240-52. doi: 10.1111/j.1526-4610.2006.00289.x.
Landy S, DeRossett SE, Rapoport A, Rothrock J, Ames MH, McDonald SA, Burch SP. Two double-blind, multicenter, randomized, placebo-controlled, single-dose studies of sumatriptan/naproxen sodium in the acute treatment of migraine: function, productivity, and satisfaction outcomes. MedGenMed. 2007 Jun 7;9(2):53.
Smith T, Blumenthal H, Diamond M, Mauskop A, Ames M, McDonald S, Lener S, Burch S. Sumatriptan/Naproxen sodium for migraine: efficacy, health related quality of life, and satisfaction outcomes. Headache. 2007 May;47(5):683-92. doi: 10.1111/j.1526-4610.2007.00790.x.
4. Cady RK, et al. Consistent medication satisfaction with sumatriptan RT Technology and naproxen sodium for acute migraine treatment. Poster presented at 13th Congress of the International Headache Society (IHS), June 28-July 1, 2007; Stockholm, Sweden.
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.
Kimel M, Hsieh R, McCormack J, Burch SP, Revicki DA. Validation of the revised Patient Perception of Migraine Questionnaire (PPMQ-R): measuring satisfaction with acute migraine treatment in clinical trials. Cephalalgia. 2008 May;28(5):510-23. doi: 10.1111/j.1468-2982.2007.01524.x. Epub 2008 Mar 31.
Other Identifiers
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113403
Identifier Type: -
Identifier Source: org_study_id