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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00300924
Other study ID # Merck 075-00
Secondary ID Merk 075-00
Status Completed
Phase Phase 3
First received March 9, 2006
Last updated May 27, 2008
Start date March 2006
Est. completion date January 2007

Study information

Verified date May 2008
Source Diamond Headache Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Rizatriptan co-administered with Acetaminophen


Locations

Country Name City State
United States Diamond Headache Clinic Chicago Illinois
United States Westside Family Medical Center Kalamazoo Michigan
United States Elkind Headache Center Mount Vernon New York
United States SanFrancisco Headache Clinic San Francisco California
United States Clinvest Springfield Missouri
United States Mercy Health Research St. Louis Missouri
United States ClinExcel West Chester Ohio

Sponsors (2)

Lead Sponsor Collaborator
Diamond Headache Clinic Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 24 hour sustained pain relief
Secondary Pain relief at 30, 45,60,90 minutes and 4 hours post dose
Secondary Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose
Secondary 24 sustained pain freedom
Secondary Associated symptoms of phonophobia, photophobia, nausea and vomiting
Secondary Functional disability
Secondary Use of rescue medication
Secondary Self-reported adverse experiences
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