The purpose of the study is to evaluate the efficacy of PG-OA-10CN and PG-OA-5TH tablets as a better pain reliever in patients with moderate to severe chronic pain due to osteoarthritis of the knee than a placebo.
Subjects will be enrolled in the study for a maximum of 36 days, including a 7-day screening period, 28 days of active product administration, and followed by a post-treatment follow-up within 1 day. The primary objective of this study is: * To evaluate the efficacy of PG-OA-10CN and PG-OA-5TH for the treatment of pain associated with osteoarthritis of the knee, compared to a placebo control. The secondary objectives of this study are: * To evaluate differences of efficacy between PG-OA-10CN and PG-OA-5TH * To evaluate the impact of PG-OA-10CN and PG-OA-5TH for stiffness, function in daily living, function in sport and recreation, and knee related quality of life as assessed by the KOOS. * To evaluate the safety of PG-OA-10CN and PG-OA-5TH for the treatment of pain associated with osteoarthritis of the knee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Pure Green Pharmaceuticals
West Bloomfield, Michigan, United States
RECRUITINGPain as assessed by Numerical Pain Rating Scale (NPRS)
To evaluate the impact of PG-OA-10CN and PG-OA-10TC on the subject's osteoarthritis of the knee pain as assessed by utilizing a Numeric Pain Rating Scale (NPRS). NPRS is from 0-10, where higher scores indicate worse pain and lower scores indicate less pain reported by the subject.
Time frame: 28 Days
Pain as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
To evaluate the impact of PG-OA-10CN and PG-OA-10TC on the subject's osteoarthritis of the knee pain as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS). KOOS is scored from 0-100, where 0 represents extreme problems and 100 represents no problems, as reported by the subject.
Time frame: 28 Days
Incidence of treatment-related adverse events as assessed by CTCAE v4.0.
To evaluate the safety of PG-OA-10CN and PG-OA-10TC for the treatment of pain associated with osteoarthritis of the knee compared to a placebo control assessed by Common Terminology Criteria For Adverse Events (CTCAE) v4.0.
Time frame: 28 Days
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