NCT01554579

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Gefapixant	BID
DRUG	Sugar Pill	Placebo

Timeline

• Start date: 2012-03-29
• Primary completion: 2013-11-11
• Completion: 2013-11-21
• First posted: 2012-03-15
• Last updated: 2019-06-27
• Results posted: 2017-03-01

Locations

34 sites across 1 country: United States