To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of the knee.
This is a randomized withdrawal design study, containing a 4 week open-label period followed by a 6 week double-blind period. The total treatment period will be 10 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
202
ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed
Placebo - 2 placebo capsules twice daily NSAID- as prescribed
Subject's Assessment of Arthritis Pain Intensity
Subject reported 24-hour average pain score measured by Visual Analogue Scale
Time frame: 6 weeks
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index
Self administered, patient-centered, health status questionnaire
Time frame: 6 weeks
Subject's Global Assessment of Arthritis Status
Subject reported pain intensity measured by Visual Analog Scale
Time frame: 6 weeks
Cognitive Functioning in Patients with Chronic Pain
Subject reported assessment of cognitive functioning
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site Reference ID/Investigator# 61226
Phoenix, Arizona, United States
Site Reference ID/Investigator# 61221
Phoenix, Arizona, United States
Site Reference ID/Investigator# 61241
Tucson, Arizona, United States
Site Reference ID/Investigator# 61257
Anaheim, California, United States
Site Reference ID/Investigator# 61246
Fresno, California, United States
Site Reference ID/Investigator# 61242
La Mesa, California, United States
Site Reference ID/Investigator# 61204
Long Beach, California, United States
Site Reference ID/Investigator# 61258
North Hollywood, California, United States
Site Reference ID/Investigator# 61265
Milford, Connecticut, United States
Site Reference ID/Investigator# 61234
DeLand, Florida, United States
...and 21 more locations