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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00300924
First Posted: March 10, 2006
Last Update Posted: May 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Diamond Headache Clinic
  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
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.

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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*

  Contacts and Locations
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
  More Information

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 Submitted: March 9, 2006
First Posted: March 10, 2006
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