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)

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758836
• Other study ID #: 0974-046
• Secondary ID: 2008_551CTRI/200
• Status: Completed
• Phase: Phase 2
• Start date: December 3, 2008
• Est. completion date: August 24, 2009

Study information

• Verified date: September 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 683
• Est. completion date: August 24, 2009
• Est. primary completion date: August 24, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• placebo

• ibuprofen

• acetominophen

• telcagepant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Pain Freedom at Two Hours Post-dose	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).	2 hours post-dose
Primary	Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count =4 in One or More Treatment Groups)	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.	Up to 48 hours post-dose
Primary	Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count =4 in One or More Treatment Groups)	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.	Up to 14 days post-dose
Secondary	Percentage of Participants With Pain Relief at 2 Hours Post-dose.	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).	2 hours post-dose