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A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine
This study has been completed.
Sponsor:
Diamond Headache Clinic
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Diamond Headache Clinic
ClinicalTrials.gov Identifier:
NCT00300924
First received: March 9, 2006
Last updated: May 27, 2008
Last verified: May 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Migraine | Drug: Rizatriptan co-administered with Acetaminophen | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Diamond Headache Clinic:
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
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2006 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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*
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300924
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300924
Locations
| United States, California | |
| SanFrancisco Headache Clinic | |
| San Francisco, California, United States, 94109 | |
| United States, Illinois | |
| Diamond Headache Clinic | |
| Chicago, Illinois, United States, 60614 | |
| United States, Michigan | |
| Westside Family Medical Center | |
| Kalamazoo, Michigan, United States, 49009 | |
| United States, Missouri | |
| Clinvest | |
| Springfield, Missouri, United States | |
| Mercy Health Research | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New York | |
| Elkind Headache Center | |
| Mount Vernon, New York, United States, 10550 | |
| United States, Ohio | |
| ClinExcel | |
| West Chester, Ohio, United States, 44121 | |
Sponsors and Collaborators
Diamond Headache Clinic
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Merle Diamond, M.D. | Diamond Headache Clinic |
More Information
| Responsible Party: | Karin E. Brooks, BSN, RN Director of Clinical Research, Diamond Headache Clinic |
| ClinicalTrials.gov Identifier: | NCT00300924 History of Changes |
| Other Study ID Numbers: |
Merck 075-00 Merk 075-00 |
| Study First Received: | March 9, 2006 |
| Last Updated: | May 27, 2008 |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Acetaminophen Rizatriptan Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 18, 2017