Back to resultsA Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine
Primary Purpose
Migraine
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rizatriptan co-administered with Acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility 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*
Sites / Locations
- SanFrancisco Headache Clinic
- Diamond Headache Clinic
- Westside Family Medical Center
- Clinvest
- Mercy Health Research
- Elkind Headache Center
- ClinExcel
Outcomes
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
Full Information
NCT ID
NCT00300924
First Posted
March 9, 2006
Last Updated
May 27, 2008
Sponsor
Diamond Headache Clinic
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00300924
Brief Title
A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine
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 Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Diamond Headache Clinic
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rizatriptan co-administered with Acetaminophen
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
24 hour sustained pain relief
Title
Pain relief at 30, 45,60,90 minutes and 4 hours post dose
Title
Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose
Title
24 sustained pain freedom
Title
Associated symptoms of phonophobia, photophobia, nausea and vomiting
Title
Functional disability
Title
Use of rescue medication
Title
Self-reported adverse experiences
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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*
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merle Diamond, M.D.
Organizational Affiliation
Diamond Headache Clinic
Official's Role
Study Director
Facility Information:
Facility Name
SanFrancisco Headache Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Westside Family Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Clinvest
City
Springfield
State/Province
Missouri
Country
United States
Facility Name
Mercy Health Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Elkind Headache Center
City
Mount Vernon
State/Province
New York
ZIP/Postal Code
10550
Country
United States
Facility Name
ClinExcel
City
West Chester
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine
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