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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00758836

First received: September 23, 2008

Last updated: April 12, 2010

Last verified: April 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 23, 2008

Last Updated Date

April 12, 2010

Start Date ^ICMJE

December 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00758836 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Test the safety and tolerability of MK0974 when co-administered with acetaminophen or ibuprofen in the treatment of acute migraine. [ Time Frame: Up to 2 weeks after study drug administration. ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Migraine

Intervention ^ICMJE

Drug: telcagepant
MK0974 280 mg tablets at onset of migraine.
Drug: Comparator: MK0974 + Ibuprofen
MK0974 280 mg tablets + Ibuprofen 400 mg tablets at onset of migraine.
Drug: Comparator: MK0974 + Acetaminophen
MK0974 280 mg tablets + Acetaminophen 1000 mg tablets at onset of migraine.
Drug: Comparator: placebo (unspecified)
Placebo tablets taken at onset of migraine.

Study Arm (s)

Experimental: 1
MK0974

Intervention: Drug: telcagepant
Experimental: 2
MK0974 plus Ibuprofen

Intervention: Drug: Comparator: MK0974 + Ibuprofen
Experimental: 3
MK0974 plus Acetaminophen

Intervention: Drug: Comparator: MK0974 + Acetaminophen
Placebo Comparator: 4
Placebo

Intervention: Drug: Comparator: placebo (unspecified)

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

628

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00758836

Other Study ID Numbers ^ICMJE

2008_551, MK0974-046

Has Data Monitoring Committee

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

April 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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