Oldsmar

This trial studies the safety and tolerability of different doses of PCRX-201, an investigational injection, for adults aged 45 to 80 with painful osteoarthritis of the knee. It compares two doses of PCRX-201 to placebo over one year, assessing adverse events and exploring effects on knee pain and joint function. The study includes two parts using PCRX-201 manufactured by different processes, enrolling 135 participants with specific knee osteoarthritis grades. Participants receive a single knee injection of PCRX-201 or placebo after a steroid pretreatment with methylprednisolone acetate. The study randomly assigns subjects to dose groups stratified by knee osteoarthritis severity using X-rays and MRI or ultrasound for synovitis assessment. Part A enrolls 45 subjects Part B enrolls 90 subjects, contingent on drug availability. Both parts include careful screening and dosing procedures. Participants attend multiple clinic visits for pretreatment, injection, and follow-up assessments. Visits occur weekly, bi-weekly, and then monthly through Week 52, followed by 8 visits over the next four years. Researchers monitor adverse events, inflammation markers, antibody levels, and knee pain through questionnaires and laboratory tests. The total participation can last up to five years for long-term safety and effectiveness monitoring.

Researchers are evaluating whether a modified version of metaxalone 640 mg can reduce pain in adults aged 18 to 80 years who have newly occurring low back or leg pain due to acute lumbosacral musculoskeletal conditions with spinal stenosis and sciatica. This study is a phase 4, double-blind, randomized, placebo-controlled trial designed to compare the effects of the active drug with a placebo. The goal is to understand the impact on pain levels, physical activity, and sleep interference. Participants will be randomly assigned to receive either metaxalone 640 mg capsules or inactive placebo capsules. Both treatments are taken orally every six hours for seven days alongside standard care. The study includes an initial pilot phase followed by a larger randomized phase to ensure proper evaluation with adequate participant numbers. During the study, participants will complete surveys on day 1 before starting treatment and again seven days later to report on pain amount and quality, as well as how pain affects their physical activities and sleep. Researchers will monitor changes in pain using the Numeric Pain Scale from day 1 to day 7. The total participation involves these assessments and treatment over the one-week period with attention to any safety or health changes.