A Four-Week Multicenter Study Evaluating the Safety and Efficacy of AF-219 in Subjects With Osteoarthritis of the Knee
The purpose of this study is to assess the efficacy of a single dose level of AF-219 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, global assessment of OA, treatment response and health outcomes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- The primary efficacy endpoint of this study is change from Baseline (Week 4 to Baseline) of the weekly average daily NPRS (average pain) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- WOMAC Scores [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- Daily Pain Scores [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- Patient Global Assessment of Osteoarthritis [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- Patient's and Clinician's Global Impression of Change [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- Rescue medication usage [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- Withdrawal for lack of efficacy [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- SF-36 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Sugar pill||
Drug: Sugar Pill
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 AF-219 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).
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