The purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen...
Date First Received: March 9, 2006
Last Updated: May 27, 2008
Verified by: Diamond Headache Clinic, May 2008
Clinical Trial Phase: Phase 3 | Start Date: March 2006
Overall Status: Completed
Estimated Enrollment: 200
Brief Summary
Official Title: “A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10mg Co-Administered With Acetaminophen for the Treatment of Acute Migraine.”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- To compare the efficacy of rizatriptan co-administered with acetaminophen to placebo, acetaminophen and rizatriptan for the acute treatment of migraine, as measured by the percentage of patients with pain relief at 2 hours.
Secondary:
- 24 hour sustained pain relief
- Pain relief at 30, 45,60,90 minutes and 4 hours post dose
- Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose
- 24 sustained pain freedom
- Associated symptoms of phonophobia, photophobia, nausea and vomiting
- Functional disability
- Use of rescue medication
- Self-reported adverse experiences
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Subject is at least 18 years of age
- Subject has at least a 6 month history of migraine, with or without aura
- Subject can distinguish between migraine attacks and other types of headaches
- Subject of childbearing potential agrees to use adequate contraception
Exclusion Criteria:
- Subject typically has fewer than 1 or greater than 6 migraine attacks per month
- Subject typically has greater than 10 headache days per month
- Subject has evidence of ischemic heart disease
- Subject has uncontrolled high blood pressure
- Subject has a history, within 1 year, or current evidence of drug or alcohol abuse
- *This list is not all inclusive*
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Diamond Headache Clinic
SanFrancisco Headache Clinic
San Francisco California 94109 United States
Diamond Headache Clinic
Chicago Illinois 60614 United States
Westside Family Medical Center
Kalamazoo Michigan 49009 United States
Clinvest
Springfield Missouri United States
Mercy Health Research
St. Louis Missouri 63141 United States
Elkind Headache Center
Mount Vernon New York 10550 United States
ClinExcel
West Chester Ohio 44121 United States
Overall Clinical Trial Officials and Contacts
Merle Diamond, M.D. Study Director Diamond Headache Clinic
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300924
Study ID Number: Merck 075-00
ClinicalTrials.gov Identifier: NCT00300924
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
