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