- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01554579
A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects who satisfy entry criteria at Screening will enter the Washout Phase, discontinuing their current nonsteroidal anti-inflammatory drug (NSAID) therapy.
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).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85018
- Afferent Investigative Site
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Phoenix, Arizona, United States, 85027
- Afferent Investigative Site
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California
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San Diego, California, United States, 92108
- Afferent Investigative Site
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Florida
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Clearwater, Florida, United States, 33756
- Afferent Investigative Site
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Orlando, Florida, United States, 32806
- Afferent Investigative Site
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Pinellas Park, Florida, United States, 33781
- Afferent Investigative Site
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Georgia
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Atlanta, Georgia, United States, 30329
- Afferent Investigative Site
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Kansas
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Wichita, Kansas, United States, 67203
- Afferent Investigative Site
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Massachusetts
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New Bedford, Massachusetts, United States, 02740
- Afferent Investigative Site
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Watertown, Massachusetts, United States, 02472
- Afferent Investigative Site
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Michigan
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Troy, Michigan, United States, 48098
- Afferent Investigative Site
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Mississippi
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Olive Branch, Mississippi, United States, 38654
- Afferent Investigative Site
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Missouri
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Hazelwood, Missouri, United States, 63042
- Afferent Investigative Site
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Saint Louis, Missouri, United States, 63141
- Afferent Investigative Site
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- Afferent Investigative Site
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North Carolina
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Asheville, North Carolina, United States, 28803
- Afferent Investigative Site
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Greensboro, North Carolina, United States, 27408
- Afferent Investigative Site
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Winston-Salem, North Carolina, United States, 27103
- Afferent Investigative Site
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Ohio
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Cincinnati, Ohio, United States, 45219
- Afferent Investigative Site
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Toledo, Ohio, United States, 43623
- Afferent Investigative Site
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Oregon
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Medford, Oregon, United States, 97504
- Afferent Investigative Site
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Afferent Investigative Site
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Rhode Island
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Warwick, Rhode Island, United States, 02886
- Afferent Investigative Site
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South Carolina
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Greer, South Carolina, United States, 29650
- Afferent Investigative Site
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Mount Pleasant, South Carolina, United States, 29464
- Afferent Investigative Site
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Texas
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Austin, Texas, United States, 78705
- Afferent Investigative Site
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Dallas, Texas, United States, 75231
- Afferent Investigative Site
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Houston, Texas, United States, 77062
- Afferent Investigative Site
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San Antonio, Texas, United States, 78209
- Afferent Investigative Site
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San Antonio, Texas, United States, 78229
- Afferent Investigative Site
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Utah
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Clinton, Utah, United States, 84015
- Afferent Investigative Site
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Virginia
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Roanoke, Virginia, United States, 24018
- Afferent Investigative Site
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Washington
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Renton, Washington, United States, 98057
- Afferent Investigative Site
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Wisconsin
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Kenosha, Wisconsin, United States, 53142
- Afferent Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Sugar pill
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Placebo
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Experimental: Gefapixant
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BID
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)
Time Frame: 2 Weeks
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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.
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2 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WOMAC Scores
Time Frame: 4 Weeks
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This is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
This is a questionnaire that asks subjects to evaluate their pain, stiffness, and physical activities affecting their knee over the past 48 hours.
Subjects evaluate their pain, stiffness and physical activities by selecting a number between 0 and 10 where 0 is no pain/no stiffness/no difficulty doing physical activities and 10 is extreme pain/extreme stiffness/extreme difficulty doing physical activities.
The questionnaire was administered at Screening, Baseline and at the end of Week 4 by telephone (an interactive voice response system [IVRS]) before bedtime.
The scores for each category are totaled (range is 0-100).
A lower total score means less pain and a higher total score means greater pain.
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4 Weeks
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SF-36
Time Frame: 4 Weeks
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The SF-36 (acute version 2) was a 36 question survey administered at Baseline and at the end of study or early termination (Week 4).
The questionnaire contained numerous domain scores to evaluate physical function, mental function, general health, bodily pain, social functioning and vitality.
The question of interest for the analysis was question #1 regarding walking pain.
Scores range from 0 - 100.
A lower score means decreased pain while walking and a higher score means increased pain while walking.
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4 Weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7264-004
- AF219004 (Other Identifier: Afferent Pharmaceuticals)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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