Overview

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

Status:
Completed
Trial end date:
2013-11-21
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Afferent Pharmaceuticals, Inc.
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