A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee
Completed · Phase 2 · Has a placebo group
Conditions studied: Osteoarthritis of the Knee
In brief
The purpose of this study is to assess the efficacy of a single dose level of gefapixant (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA) of the knee compared with placebo after 4 weeks of treatment. The study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes.
Key facts
- Study ID
- NCT01554579
- Run by
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- People needed
- 171
- Starts
- 2012-03-29
- Expected to finish
- 2013-11-21
- Last updated by the study team
- 2019-06-27
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men or women
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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