Migraine Treatment Satisfaction With Treximet Versus Concomitant 2 Aleve and Imitrex
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|ClinicalTrials.gov Identifier: NCT01450995|
Recruitment Status : Completed
First Posted : October 13, 2011
Last Update Posted : October 13, 2011
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Treximet Drug: Imitrex and two Aleve||Phase 4|
A migraine headache is characterized by pain felt on one and sometimes both side(s) of the head. Other symptoms associated with a migraine headache may include nausea, vomiting, and sensitivity to light and sound. A migraine can last a few hours or up to one or two days.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, 6 Month Crossover Study Evaluating Migraine Patient Satisfaction Comparing Treximet to 2 Aleve and 100mg Imitrex Taken Concomitantly|
|Study Start Date :||December 2009|
|Primary Completion Date :||May 2011|
|Study Completion Date :||May 2011|
|Active Comparator: Treximet||
Tablet form, one tablet dose, one tablet at migraine onset with second tablet for persistent or recurring migraine two hours after first dose.
|Active Comparator: Imitrex and Aleve||
Drug: 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
- Measurement of patient satisfaction of Treximet vs 2 Aleve and 100mg Imitrex [ Time Frame: one year ]
- Measurement of time to onset of pain relief [ Time Frame: One year ]
- Measurement of time to onset of pain free [ Time Frame: one year ]
- Measurement of 24 hour sustained pain free [ Time Frame: One year ]
- Measurement of 24 hour sustained pain relief [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450995
|United States, Tennessee|
|Wesley Headache Clinic|
|Memphis, Tennessee, United States, 38018|
|Principal Investigator:||Stephen H Landy, M.D.||Wesley Headache Clinic|