This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of Intra-Articular (IA) verapamil in the treatment of joint pain in patients with knee osteoarthritis (OA). Subjects will discontinue all analgesic medications for the entire duration of the study, except for acetaminophen (taken on an as needed basis at no more than 2 g/day). At visit 2, subjects who meet all entry criteria will be randomized to receive a single injection of IA verapamil or IA placebo at a ratio of 1:1. Treatments will be given with fluoroscopy or ultrasound to confirm needle placement. Subjects will be monitored for blood pressure and heart rate (sitting and standing) for at least 1 hour post-injection. Subjects will be evaluated at weeks 1, 2, 3, 4, 6, 8, and 12 after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
Compare Efficacy of Verapmil vs Placebo at Week 4
To compare the efficacy of IA verapamil versus IA placebo for pain relief using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 4.
Time frame: 4 weeks
Compare Efficacy of Verapamil to Placebo Compared to Baseline
To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • WOMAC total and subscale scores for pain, function, and stiffness at each visit
Time frame: 13 weeks
Compare Efficacy of Verapamil to Placebo Compared to Baseline
To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • WOMAC pain subscale as measured from 2 to 12 weeks post-treatment using an AUC approach
Time frame: 13 weeks
Compare Efficacy of Verapamil to Placebo Compared to Baseline
To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • In-clinic 24-hour recall pain intensity using the 0-10 numerical rating scale (NRS) at each visit
Time frame: 13 weeks
Compare Efficacy of Verapamil to Placebo Compared to Baseline
To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • Difference in the current in-clinic pain intensity using the 0-10 NRS before and after exercise at each visit
Time frame: 13 weeks
Compare Efficacy of Verapamil to Placebo Compared to Baseline
To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • Response rate
Time frame: 13 weeks
Compare Efficacy of Verapamil to Placebo Compared to Baseline
To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • Patient Global Impression of Change (PGIC)
Time frame: 13 weeks
Compare Efficacy of Verapamil to Placebo Compared to Baseline
To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • Rescue medication use
Time frame: 13 weeks
Number of Subjects With Adverse Events
Compare the safety of IA verapamil versus IA placebo using adverse events (AEs) as a comparator
Time frame: 13 weeks
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