A Four-Week Multicenter Study Evaluating the Safety and Efficacy of AF-219 in Subjects With Osteoarthritis of the Knee
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 40 - 80 |
Updated: | 1/1/2014 |
Start Date: | March 2012 |
End Date: | December 2013 |
Contact: | Afferent Director, MD |
Phone: | 650-286-1423 |
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.
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.
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).
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).
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
- Minimum pain at Screening and during Washout
- Ambulatory
- Have provided written informed consent
We found this trial at
34
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