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A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine

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ClinicalTrials.gov Identifier: NCT00300924
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : May 28, 2008
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Diamond Headache Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Rizatriptan co-administered with Acetaminophen Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : March 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 24 hour sustained pain relief
  2. Pain relief at 30, 45,60,90 minutes and 4 hours post dose
  3. Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose
  4. 24 sustained pain freedom
  5. Associated symptoms of phonophobia, photophobia, nausea and vomiting
  6. Functional disability
  7. Use of rescue medication
  8. Self-reported adverse experiences


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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*


Information from the National Library of Medicine

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): NCT00300924


Locations
United States, California
SanFrancisco Headache Clinic
San Francisco, California, United States, 94109
United States, Illinois
Diamond Headache Clinic
Chicago, Illinois, United States, 60614
United States, Michigan
Westside Family Medical Center
Kalamazoo, Michigan, United States, 49009
United States, Missouri
Clinvest
Springfield, Missouri, United States
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, New York
Elkind Headache Center
Mount Vernon, New York, United States, 10550
United States, Ohio
ClinExcel
West Chester, Ohio, United States, 44121
Sponsors and Collaborators
Diamond Headache Clinic
Merck Sharp & Dohme Corp.
Investigators
Study Director: Merle Diamond, M.D. Diamond Headache Clinic

Responsible Party: Karin E. Brooks, BSN, RN Director of Clinical Research, Diamond Headache Clinic
ClinicalTrials.gov Identifier: NCT00300924     History of Changes
Other Study ID Numbers: Merck 075-00
Merk 075-00
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: May 28, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acetaminophen
Rizatriptan
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action