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

May 27, 2008 updated by: Diamond Headache Clinic

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

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
    • California
      • San Francisco, California, United States, 94109
        • SanFrancisco Headache Clinic
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Diamond Headache Clinic
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Westside Family Medical Center
    • Missouri
      • Springfield, Missouri, United States
        • Clinvest
      • St. Louis, Missouri, United States, 63141
        • Mercy Health Research
    • New York
      • Mount Vernon, New York, United States, 10550
        • Elkind Headache Center
    • Ohio
      • West Chester, Ohio, United States, 44121
        • ClinExcel

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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*

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Use of rescue medication
Functional disability
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
Self-reported adverse experiences

Collaborators and Investigators

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

Sponsor

Diamond Headache Clinic

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Merle Diamond, M.D., Diamond Headache Clinic

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

March 1, 2006

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

March 9, 2006

First Submitted That Met QC Criteria

March 9, 2006

First Posted (ESTIMATE)

March 10, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2008

Last Update Submitted That Met QC Criteria

May 27, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Merck 075-00
  • Merk 075-00

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.

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