A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee
NCT ID: NCT01554579
Last Updated: 2019-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
171 participants
INTERVENTIONAL
2012-03-29
2013-11-21
Brief Summary
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The study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes.
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Detailed Description
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Up to 220 subjects who fulfill flare (and other entry) criteria will be randomized to gefapixant or placebo.
Subjects will complete Treatment Visits 1, 2, 3, and 4 weeks after starting study drug. At each Treatment Visit, subjects will undergo efficacy assessments and safety procedures. During the Washout and Treatment Phases subjects will complete the 'average pain' Numeric Pain Rating Scale (NPRS) and count of rescue medication used for the preceding 24 hours.
Subjects will return 2 weeks after their last Treatment Visit (for a Follow-Up Visit).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sugar pill
Sugar Pill
Placebo
Gefapixant
Gefapixant
BID
Interventions
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Gefapixant
BID
Sugar Pill
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women of child bearing potential must not be pregnant during the study and must use two forms of birth control
* Men and their female partners must use two forms of birth control
* Clinical and radiographic evidence of chronic knee osteoarthritis
* An average NPRS score of \>=5 and \<=9 over a 4-7 day washout period of their previous osteoarthritis medications
* Ambulatory
* Have provided written informed consent
40 Years
80 Years
ALL
No
Sponsors
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Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Locations
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Afferent Investigative Site
Phoenix, Arizona, United States
Afferent Investigative Site
Phoenix, Arizona, United States
Afferent Investigative Site
San Diego, California, United States
Afferent Investigative Site
Clearwater, Florida, United States
Afferent Investigative Site
Orlando, Florida, United States
Afferent Investigative Site
Pinellas Park, Florida, United States
Afferent Investigative Site
Atlanta, Georgia, United States
Afferent Investigative Site
Wichita, Kansas, United States
Afferent Investigative Site
New Bedford, Massachusetts, United States
Afferent Investigative Site
Watertown, Massachusetts, United States
Afferent Investigative Site
Troy, Michigan, United States
Afferent Investigative Site
Olive Branch, Mississippi, United States
Afferent Investigative Site
Hazelwood, Missouri, United States
Afferent Investigative Site
St Louis, Missouri, United States
Afferent Investigative Site
Albuquerque, New Mexico, United States
Afferent Investigative Site
Asheville, North Carolina, United States
Afferent Investigative Site
Greensboro, North Carolina, United States
Afferent Investigative Site
Winston-Salem, North Carolina, United States
Afferent Investigative Site
Cincinnati, Ohio, United States
Afferent Investigative Site
Toledo, Ohio, United States
Afferent Investigative Site
Medford, Oregon, United States
Afferent Investigative Site
Duncansville, Pennsylvania, United States
Afferent Investigative Site
Warwick, Rhode Island, United States
Afferent Investigative Site
Greer, South Carolina, United States
Afferent Investigative Site
Mt. Pleasant, South Carolina, United States
Afferent Investigative Site
Austin, Texas, United States
Afferent Investigative Site
Dallas, Texas, United States
Afferent Investigative Site
Houston, Texas, United States
Afferent Investigative Site
San Antonio, Texas, United States
Afferent Investigative Site
San Antonio, Texas, United States
Afferent Investigative Site
Clinton, Utah, United States
Afferent Investigative Site
Roanoke, Virginia, United States
Afferent Investigative Site
Renton, Washington, United States
Afferent Investigative Site
Kenosha, Wisconsin, United States
Countries
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Other Identifiers
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AF219004
Identifier Type: OTHER
Identifier Source: secondary_id
7264-004
Identifier Type: -
Identifier Source: org_study_id
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