Phase 3Not yet recruitingAge-related condition
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Intra-Articular Injection of a Solution of High and Low Molecular Weight Sodium Hyaluronate (HL-01) in the Treatment of Pain in Symptomatic Knee Osteoarthritis
- Sponsor
- IBSA Institut Biochimique SA (Industry)
- Enrolment
- 704 planned
- Conditions
- Osteo Arthritis of the Knee
- Interventions
- Sodium hyaluronate solution - 3.36%; Sterile buffered solution
- Ages
- adults, older adults
- Registry
- NCT07819461
Full record on ClinicalTrials.gov
From the registry
The goal of this clinical trial is to test HL-01 in patients with knee osteoarthritis pain. The main question\[s\] it aims to answer are: * Measure the change in average daily knee pain intensity scores from baseline to the end of the study using a pain scale that measures pain on a scale of 0 to 10 * Measure the change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scales measuring knee pain, stiffness, and function from baseline to the end of the study * Measure the change in EuroQol EQ-5D-5L quality of life assessments from baseline to end of the study * Measure change of participant and physician assessment of how the target knee pain and function are affected by the condition from baseline to end of the study * Measure how often rescue medication is taken from baseline to end of the study * Assess how well participants tolerate the study medication injection (investigational drug or placebo) * Assess whether there are any adverse reactions or side effects from the study medication injection Participants will be asked to complete the following: *…
Primary outcomes
- Change from Baseline of the average daily pain intensity score.
History
Primary completion expected
Last registry update
Started
Registered