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

Migraine Clinical Trial

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.

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

• Migraine
• Migraine Disorders

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