A Study to Test the Safety and Effectiveness of MK0974 Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura. - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00758836

Purpose

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.

Condition	Intervention	Phase
Migraine	Drug: telcagepant Drug: Comparator: MK0974 + Ibuprofen Drug: Comparator: MK0974 + Acetaminophen Drug: Comparator: placebo (unspecified)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Migraine

Drug Information available for: Ibuprofen Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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. [ Time Frame: Pain freedom two hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Test the safety and tolerability of MK0974 when co-administered with acetaminophen or ibuprofen in the treatment of acute migraine. [ Time Frame: Pain Freedom two hours post dose ] [ Designated as safety issue: Yes ]

Enrollment:	628
Study Start Date:	December 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 MK0974	Drug: telcagepant MK0974 280 mg tablets at onset of migraine.
Experimental: 2 MK0974 plus Ibuprofen	Drug: Comparator: MK0974 + Ibuprofen MK0974 280 mg tablets + Ibuprofen 400 mg tablets at onset of migraine.
Experimental: 3 MK0974 plus Acetaminophen	Drug: Comparator: MK0974 + Acetaminophen MK0974 280 mg tablets + Acetaminophen 1000 mg tablets at onset of migraine.
Placebo Comparator: 4 Placebo	Drug: Comparator: placebo (unspecified) Placebo tablets taken at onset of migraine.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758836

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hewitt DJ, Martin V, Lipton RB, Brandes J, Ceesay P, Gottwald R, Schaefer E, Lines C, Ho TW. Randomized controlled study of telcagepant plus Ibuprofen or acetaminophen in migraine. Headache. 2011 Apr;51(4):533-43.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00758836 History of Changes
Other Study ID Numbers:	2008_551, MK0974-046
Study First Received:	September 23, 2008
Last Updated:	April 12, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acetaminophen
Ibuprofen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012