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Trial record 2 of 459 for:    "Migraine Disorders"
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The Efficacy and Safety of Intra-oral Topical Ketoprofen for the Treatment of Acute Migraine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Behar, Caren, M.D..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Behar, Caren, M.D.
ClinicalTrials.gov Identifier:
NCT01228552
First received: October 25, 2010
Last updated: June 4, 2011
Last verified: October 2010
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of intra-oral topical ketoprofen for the treatment of acute migraine.


Condition Intervention Phase
Migraine Disorders
Migraine Headache
Migraine
Acute Migraine
 Drug: Topical, intra-oral ketoprofen gel
Other: Placebo gel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind, Placebo Controlled Phase III Trial to Determine the Efficacy and Safety of Topical Intra-oral Ketoprofen for the Treatment of Acute Migraine

Resource links provided by NLM:

Drug Information available for: Ketoprofen
U.S. FDA Resources

Further study details as provided by Behar, Caren, M.D.:

Primary Outcome Measures:
  • Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment [ Time Frame: Within 240 minutes post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain free status at 30, 60, 120, and 240 minutes post-treatment based on headache severities reported in patient's journals [ Time Frame: Within 240 minutes post-treatment ] [ Designated as safety issue: No ]
  • Pain relief at 30, 60, and 240 minutes post-treatment based on headache severities reported in patient's journals [ Time Frame: Within 240 minutes post-treatment ] [ Designated as safety issue: No ]
  • Relief of Photophobia at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240 minutes post-treatment ] [ Designated as safety issue: No ]
  • Relief of Phonophobia at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240 minutes post-treatment ] [ Designated as safety issue: No ]
  • Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment [ Time Frame: Within 240 minutes post-treatment ] [ Designated as safety issue: No ]
  • Relief of Vomiting 30, 60, 120 and 240 minutes post-treatment [ Time Frame: Within 240 minutes post-treatment ] [ Designated as safety issue: No ]
  • Need for Rescue Medication between the time of dosing to 240 minutes [ Time Frame: Within 240 minutes post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topical, intra-oral ketoprofen gel Drug: 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 Comparator: Placebo gel Other: 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Established diagnosis of Migraine as per IHS with aura
  • Established diagnosis of Migraine as per IHS without aura
  • At least 2 migraines per month
  • At least 18 years of age

Exclusion Criteria:

  • Pregnancy or Lactation
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228552

Contacts
Contact: Caren Behar, MD 914-584-2413 ardavsa@aol.com

Locations
United States, New York
New York Medical College Not yet recruiting
Valhalla, New York, United States, 10595
Principal Investigator: Caren Behar, MD            
Sponsors and Collaborators
Behar, Caren, M.D.
Investigators
Principal Investigator: Caren Behar, MD New York Medical College
  More Information

No publications provided

Responsible Party: Behar, Caren M.D., New York Medical College
ClinicalTrials.gov Identifier: NCT01228552     History of Changes
Other Study ID Numbers: 79,629
Study First Received: October 25, 2010
Last Updated: June 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Behar, Caren, M.D.:
Acute Migraine Treatment
Migraine Treatment
Migraine
Headache
Treatment

Additional relevant MeSH terms:
Migraine Disorders
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013