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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Lead sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 171
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)
timeFrame: 2 Weeks
Secondary outcomes:
measure: WOMAC Scores
timeFrame: 4 Weeks
measure: SF-36
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Afferent Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Afferent Investigative Site
state: Arizona
city: San Diego
country: United States
facility: Afferent Investigative Site
state: California
city: Clearwater
country: United States
facility: Afferent Investigative Site
state: Florida
city: Orlando
country: United States
facility: Afferent Investigative Site
state: Florida
city: Pinellas Park
country: United States
facility: Afferent Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Afferent Investigative Site
state: Georgia
city: Wichita
country: United States
facility: Afferent Investigative Site
state: Kansas
city: New Bedford
country: United States
facility: Afferent Investigative Site
state: Massachusetts
city: Watertown
country: United States
facility: Afferent Investigative Site
state: Massachusetts
city: Troy
country: United States
facility: Afferent Investigative Site
state: Michigan
city: Olive Branch
country: United States
facility: Afferent Investigative Site
state: Mississippi
city: Hazelwood
country: United States
facility: Afferent Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Afferent Investigative Site
state: Missouri
city: Albuquerque
country: United States
facility: Afferent Investigative Site
state: New Mexico
city: Asheville
country: United States
facility: Afferent Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Afferent Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Afferent Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Afferent Investigative Site
state: Ohio
city: Toledo
country: United States
facility: Afferent Investigative Site
state: Ohio
city: Medford
country: United States
facility: Afferent Investigative Site
state: Oregon
city: Duncansville
country: United States
facility: Afferent Investigative Site
state: Pennsylvania
city: Warwick
country: United States
facility: Afferent Investigative Site
state: Rhode Island
city: Greer
country: United States
facility: Afferent Investigative Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Afferent Investigative Site
state: South Carolina
city: Austin
country: United States
facility: Afferent Investigative Site
state: Texas
city: Dallas
country: United States
facility: Afferent Investigative Site
state: Texas
city: Houston
country: United States
facility: Afferent Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Afferent Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Afferent Investigative Site
state: Texas
city: Clinton
country: United States
facility: Afferent Investigative Site
state: Utah
city: Roanoke
country: United States
facility: Afferent Investigative Site
state: Virginia
city: Renton
country: United States
facility: Afferent Investigative Site
state: Washington
city: Kenosha
country: United States
facility: Afferent Investigative Site
state: Wisconsin
Study officials:
References: