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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00758836
First received: September 23, 2008
Last updated: April 12, 2010
Last verified: April 2010

September 23, 2008
April 12, 2010
December 2008
August 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00758836 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
A Study to Test the Safety and Effectiveness of MK0974 Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura.
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine
  • 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.
  • 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)
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. doi: 10.1111/j.1526-4610.2011.01860.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
628
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00758836
2008_551, MK0974-046
No
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2010

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