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
  Purpose

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.


Condition Intervention Phase
Migraine
Drug: placebo
Drug: ibuprofen
Drug: acetominophen
Drug: telcagepant
Phase 2

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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 683
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
Placebo Comparator: Placebo
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
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
Drug: ibuprofen Drug: telcagepant
Other Name: MK-0974
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
Drug: acetominophen
Other Name: N-acetyl-p-aminophenol (APAP)
Drug: telcagepant
Other Name: MK-0974
Placebo Comparator: Telcagepant 280 mg
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
Drug: telcagepant
Other Name: MK-0974

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00758836     History of Changes
Other Study ID Numbers: 0974-046, 2008_551, CTRI/2009/091/000291
Study First Received: September 23, 2008
Results First Received: July 18, 2014
Last Updated: August 12, 2014
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
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
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 August 21, 2014