Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00758836
First received: September 23, 2008
Last updated: August 12, 2014
Last verified: August 2014

September 23, 2008
August 12, 2014
December 2008
August 2009   (final data collection date for primary outcome measure)
  • Percentage of Participants With Pain Freedom at Two Hours Post-dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
    Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).
  • Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups) [ Time Frame: Up to 48 hours post-dose ] [ Designated as safety issue: Yes ]
    An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
  • Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups) [ Time Frame: Up to 14 days post-dose ] [ Designated as safety issue: Yes ]
    An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
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 ]
Complete list of historical versions of study NCT00758836 on ClinicalTrials.gov Archive Site
Percentage of Participants With Pain Relief at 2 Hours Post-dose. [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain relief was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0).
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 MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)
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 telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at least one drug combination is superior to telecagepant alone in the treatment of acute migraines.

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: placebo
  • Drug: ibuprofen
  • Drug: acetominophen
    Other Name: N-acetyl-p-aminophenol (APAP)
  • Drug: telcagepant
    Other Name: MK-0974
  • Placebo Comparator: Placebo
    Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
    Intervention: Drug: placebo
  • Experimental: Telcagepant 280 mg +Ibuprofen 400 mg
    Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
    Interventions:
    • Drug: ibuprofen
    • Drug: telcagepant
  • Experimental: Telcagepant 280 mg +APAP 1000 mg
    Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
    Interventions:
    • Drug: acetominophen
    • Drug: telcagepant
  • Placebo Comparator: Telcagepant 280 mg
    Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
    Intervention: Drug: telcagepant
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
683
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
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00758836
0974-046, 2008_551, CTRI/2009/091/000291
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

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