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

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Diamond Headache Clinic
ClinicalTrials.gov Identifier:
NCT00300924
First received: March 9, 2006
Last updated: May 27, 2008
Last verified: May 2008
History of Changes
  Purpose

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 Intervention Phase
Migraine
 Drug: Rizatriptan co-administered with Acetaminophen
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Diamond Headache Clinic:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 200
Study Start Date: March 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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*

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Director: Merle Diamond, M.D. Diamond Headache Clinic
  More Information

No publications provided

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
Study First Received: March 9, 2006
Last Updated: May 27, 2008
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013