The Efficacy and Safety of Intra-oral Topical Ketoprofen for the Treatment of Acute Migraine

June 4, 2011 updated by: Behar, Caren, M.D.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Valhalla, New York, United States, 10595
        • New York Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 240 minutes post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Within 240 minutes post-treatment
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
Within 240 minutes post-treatment
Relief of Photophobia at 30, 60, 120, and 240 minutes post-treatment
Time Frame: Within 240 minutes post-treatment
Within 240 minutes post-treatment
Relief of Phonophobia at 30, 60, 120, and 240 minutes post-treatment
Time Frame: Within 240 minutes post-treatment
Within 240 minutes post-treatment
Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment
Time Frame: Within 240 minutes post-treatment
Within 240 minutes post-treatment
Relief of Vomiting 30, 60, 120 and 240 minutes post-treatment
Time Frame: Within 240 minutes post-treatment
Within 240 minutes post-treatment
Need for Rescue Medication between the time of dosing to 240 minutes
Time Frame: Within 240 minutes post-treatment
Within 240 minutes post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Behar, Caren, M.D.

Investigators

  • Principal Investigator: Caren Behar, MD, New York Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimate)

October 26, 2010

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 4, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 79,629

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on Topical, intra-oral ketoprofen gel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe