The Efficacy and Safety of Intra-oral Topical Ketoprofen for the Treatment of Acute Migraine
NCT ID: NCT01228552
Last Updated: 2011-06-08
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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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2011-12-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Topical, intra-oral ketoprofen gel
Topical, intra-oral ketoprofen gel
Ketoprofen gel will be applied, using a cotton applicator, to the gingival mucosa at the onset of migraine. A second application may be used at 20 minutes, if necessary.
Placebo gel
Placebo gel
Placebo gel will be applied, using a cotton applicator, to the gingival mucosa at the onset of migraine. A second application may be used at 20 minutes, if necessary.
Interventions
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Topical, intra-oral ketoprofen gel
Ketoprofen gel will be applied, using a cotton applicator, to the gingival mucosa at the onset of migraine. A second application may be used at 20 minutes, if necessary.
Placebo gel
Placebo gel will be applied, using a cotton applicator, to the gingival mucosa at the onset of migraine. A second application may be used at 20 minutes, if necessary.
Eligibility Criteria
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Inclusion Criteria
* Established diagnosis of Migraine as per IHS without aura
* At least 2 migraines per month
* At least 18 years of age
Exclusion Criteria
* Other Headache Conditions including basilar, hemiplegic, or ophthalmoplegic migraines
* Chronic Daily Headache
* Allergy or Sensitivity to NSAIDs
* Other Severe Medical Conditions including GI bleeding, blood dyscrasias, thrombocytopenia
18 Years
75 Years
ALL
Yes
Sponsors
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Behar, Caren, M.D.
INDIV
Responsible Party
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New York Medical College
Principal Investigators
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Caren Behar, MD
Role: PRINCIPAL_INVESTIGATOR
New York Medical College
Locations
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New York Medical College
Valhalla, New York, United States
Countries
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Central Contacts
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Other Identifiers
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79,629
Identifier Type: -
Identifier Source: org_study_id
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