A Study to Test the Safety and Effectiveness of MK0974 co-Administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura.
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: telcagepant (Drug); Comparator: MK0974 + Ibuprofen (Drug); Comparator: MK0974 + Acetaminophen (Drug); Comparator: placebo (unspecified) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
This study will test the safety and how effective MK0974 is when taken with Ibuprofen or
Acetaminophen in patients with migraine with or without aura.
Clinical Details
Official title: A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK0974 Co-Administered With Ibuprofen or Acetaminophen in Patients With Migraine With or Without Aura
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluate the efficacy of MK0974 in the treatment of migraine when co-administered with acetaminophen or ibuprofen compared to MK0974 alone and compared to placebo.
Secondary outcome: Test the safety and tolerability of MK0974 when co-administered with acetaminophen or ibuprofen in the treatment of acute migraine.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Must be 18 years of age or older
- History of migraine with or without aura for more than 1 year with 1-8 moderate or
severe migraine attacks per month in the 2 months prior to starting in the study
- Willing to stay awake for at least 2 hours after taking study drug
- Able to read, understand and complete questionnaires and diaries
Exclusion Criteria:
- Breast-feeding, pregnant, or plan to become pregnant during the study
- Not able to tell migraine attack from other headaches
- Older than 50 years of age at migraine onset
- Have more than 15 headache days per month or have taken medication for acute headache
on more than 10 days per month in any of the 3 months before starting in the study
- History of gastric or small intestinal surgery
- History of heart attack, stroke, unstable angina, coronary artery bypass surgery or
transient ischemic attack in the 3 months before starting in the study
- Currently participating or have participated in a study with in investigational
compound or device in the last 30 days
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme (Australia) Pty Ltd., South Granville NSW 2142, Australia; Recruiting
David Woolner, Phone: 64-9-523-6075
Merck Sharp & Dohme IDEA Inc., Praha 162 00, Czech Republic; Recruiting
Simona Martinkova, Phone: 420-233-010-213
Laboratoires Merck Sharp & Dohme - Chibret, Paris Cedex 8 75114, France; Recruiting
Jean-Marie Goehrs, Phone: 33-1-4754-89-90
Msd Sharp & Dohme Gmbh, Haar 85540, Germany; Recruiting
Thomas Lang, Phone: 49-89-4561-1536
Merck Sharp & Dohme (New Zealand) Ltd.,, Auckland, New Zealand; Recruiting
David Woolner, Phone: 64-9523-6075
MSD (Norge) AS, Drammen 3011, Norway; Recruiting
Bard Rogstad, Phone: 47-32-20-7484
Call for Information, Springfield, Missouri 65807, United States; Recruiting
Call for Information, Bronx, New York 10461, United States; Recruiting
Additional Information
Starting date: December 2008
Ending date: June 2009
Last updated: January 30, 2009
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