A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee
2 other identifiers
interventional
171
1 country
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2012
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2012
CompletedFirst Posted
Study publicly available on registry
March 15, 2012
CompletedStudy Start
First participant enrolled
March 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2013
CompletedResults Posted
Study results publicly available
March 1, 2017
CompletedJune 27, 2019
June 1, 2019
1.6 years
March 12, 2012
September 23, 2016
June 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)
Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system \[IVRS\]) every evening before bedtime.
2 Weeks
Secondary Outcomes (2)
WOMAC Scores
4 Weeks
SF-36
4 Weeks
Study Arms (2)
Sugar pill
PLACEBO COMPARATORGefapixant
EXPERIMENTALInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Afferent Investigative Site
Phoenix, Arizona, 85018, United States
Afferent Investigative Site
Phoenix, Arizona, 85027, United States
Afferent Investigative Site
San Diego, California, 92108, United States
Afferent Investigative Site
Clearwater, Florida, 33756, United States
Afferent Investigative Site
Orlando, Florida, 32806, United States
Afferent Investigative Site
Pinellas Park, Florida, 33781, United States
Afferent Investigative Site
Atlanta, Georgia, 30329, United States
Afferent Investigative Site
Wichita, Kansas, 67203, United States
Afferent Investigative Site
New Bedford, Massachusetts, 02740, United States
Afferent Investigative Site
Watertown, Massachusetts, 02472, United States
Afferent Investigative Site
Troy, Michigan, 48098, United States
Afferent Investigative Site
Olive Branch, Mississippi, 38654, United States
Afferent Investigative Site
Hazelwood, Missouri, 63042, United States
Afferent Investigative Site
St Louis, Missouri, 63141, United States
Afferent Investigative Site
Albuquerque, New Mexico, 87102, United States
Afferent Investigative Site
Asheville, North Carolina, 28803, United States
Afferent Investigative Site
Greensboro, North Carolina, 27408, United States
Afferent Investigative Site
Winston-Salem, North Carolina, 27103, United States
Afferent Investigative Site
Cincinnati, Ohio, 45219, United States
Afferent Investigative Site
Toledo, Ohio, 43623, United States
Afferent Investigative Site
Medford, Oregon, 97504, United States
Afferent Investigative Site
Duncansville, Pennsylvania, 16635, United States
Afferent Investigative Site
Warwick, Rhode Island, 02886, United States
Afferent Investigative Site
Greer, South Carolina, 29650, United States
Afferent Investigative Site
Mt. Pleasant, South Carolina, 29464, United States
Afferent Investigative Site
Austin, Texas, 78705, United States
Afferent Investigative Site
Dallas, Texas, 75231, United States
Afferent Investigative Site
Houston, Texas, 77062, United States
Afferent Investigative Site
San Antonio, Texas, 78209, United States
Afferent Investigative Site
San Antonio, Texas, 78229, United States
Afferent Investigative Site
Clinton, Utah, 84015, United States
Afferent Investigative Site
Roanoke, Virginia, 24018, United States
Afferent Investigative Site
Renton, Washington, 98057, United States
Afferent Investigative Site
Kenosha, Wisconsin, 53142, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development
- Organization
- Afferent Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2012
First Posted
March 15, 2012
Study Start
March 29, 2012
Primary Completion
November 11, 2013
Study Completion
November 21, 2013
Last Updated
June 27, 2019
Results First Posted
March 1, 2017
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf