A Study of Rizatriptan 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...
Brief Summary
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.”
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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: January 2007
Intervention(s) in this Clinical Trial
- Drug: Rizatriptan co-administered with Acetaminophen
Outcome Measures for this Clinical Trial
Primary 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 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
Criteria for Participation in this Clinical Trial
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*
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Diamond Headache Clinic Other
Overall Clinical Trial Officials and Contacts
Merle Diamond, M.D. Study Director Diamond Headache Clinic
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300924
Study ID Number: Merck 075-00
ClinicalTrials.gov Identifier: NCT00300924
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00300924
