A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee

Osteoarthritis of the Knee Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554579
• Other study ID #: 7264-004
• Secondary ID: AF219004
• Status: Completed
• Phase: Phase 2
• Start date: March 29, 2012
• Est. completion date: November 21, 2013

Study information

• Verified date: June 2019
• Source: Afferent Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: November 21, 2013
• Est. primary completion date: November 11, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Gefapixant
BID
• Sugar Pill
Placebo

Locations

Country	Name	City	State
United States	Afferent Investigative Site	Albuquerque	New Mexico
United States	Afferent Investigative Site	Asheville	North Carolina
United States	Afferent Investigative Site	Atlanta	Georgia
United States	Afferent Investigative Site	Austin	Texas
United States	Afferent Investigative Site	Cincinnati	Ohio
United States	Afferent Investigative Site	Clearwater	Florida
United States	Afferent Investigative Site	Clinton	Utah
United States	Afferent Investigative Site	Dallas	Texas
United States	Afferent Investigative Site	Duncansville	Pennsylvania
United States	Afferent Investigative Site	Greensboro	North Carolina
United States	Afferent Investigative Site	Greer	South Carolina
United States	Afferent Investigative Site	Hazelwood	Missouri
United States	Afferent Investigative Site	Houston	Texas
United States	Afferent Investigative Site	Kenosha	Wisconsin
United States	Afferent Investigative Site	Medford	Oregon
United States	Afferent Investigative Site	Mount Pleasant	South Carolina
United States	Afferent Investigative Site	New Bedford	Massachusetts
United States	Afferent Investigative Site	Olive Branch	Mississippi
United States	Afferent Investigative Site	Orlando	Florida
United States	Afferent Investigative Site	Phoenix	Arizona
United States	Afferent Investigative Site	Phoenix	Arizona
United States	Afferent Investigative Site	Pinellas Park	Florida
United States	Afferent Investigative Site	Renton	Washington
United States	Afferent Investigative Site	Roanoke	Virginia
United States	Afferent Investigative Site	Saint Louis	Missouri
United States	Afferent Investigative Site	San Antonio	Texas
United States	Afferent Investigative Site	San Antonio	Texas
United States	Afferent Investigative Site	San Diego	California
United States	Afferent Investigative Site	Toledo	Ohio
United States	Afferent Investigative Site	Troy	Michigan
United States	Afferent Investigative Site	Warwick	Rhode Island
United States	Afferent Investigative Site	Watertown	Massachusetts
United States	Afferent Investigative Site	Wichita	Kansas
United States	Afferent Investigative Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Afferent Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	WOMAC Scores	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.	4 Weeks
Secondary	SF-36	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.	4 Weeks