Osteo Arthritis of the Knee
Conditions
Keywords
Osteoarthritis of the knee
Brief summary
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: * Provide informed consent * Knee X-ray of target knee * Complete physical health assessments (e.g., target knee assessment, height, weight, physical exam) at several timepoints throughout the study * Provide demographic information and their medical/surgical history * Provide blood and urine samples at several timepoints throughout the study * Injection of study medication (investigational drug or placebo) * Complete electronic diaries for the following: * Record average daily knee pain intensity scores during screening to confirm eligibility for the study * Record average daily knee pain intensity scores after receiving the study medication injection until they complete the study * Complete WOMAC scales assessing knee pain, stiffness, and function at baseline, Week 6, Week 12 and/or the end of the study * Complete EuroQol EQ-5D-5L quality of life assessments at baseline, Week 6, Week 12 and/or the end of the study * Complete global assessment of how the target knee pain and function are affected by the condition at baseline, Week 6, Week 12 and/or the end of the study
Interventions
DRUGSodium hyaluronate solution - 3.36%
Sodium hyaluronate solution, 3.36%, for intra-articular injection.
DRUGSterile buffered solution
Sodium chloride, for intra-articular injection.
Sponsors
IBSA Institut Biochimique SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age is between 40 and 80 years of age * Have symptoms of knee osteoarthritis (OA) for at least 6 months * Meet American College of Rheumatology criteria (clinical and radiological) for knee OA * Body mass index (BMI) is less than or equal to 40 kg/m2 * Target knee x-ray grade Kellgren-Lawerence (KL) grade 2 or 3 * Have failed at least one prior conservative therapy for knee OA in last 12 months, which includes physical therapy, NSAIDs, and other pain medications * The knee pain scores during screening and baseline must meet specified qualifying criteria for both the target and the contralateral (non-target) knees * Willing to complete all electronic diaries and only use study-provided acetaminophen for pain management while participating in the study * Have negative pregnancy tests during Screening and prior to injection and will not be pregnant or nursing or plan to be pregnant while participating in the study * Must use a highly effective birth control method if sexually active
Exclusion criteria
* Have taken or had any prohibited medications, supplements, or therapies that could have an influence on study assessments. Some may be permitted with stable dose or after stopping for a period of time. Please refer to physician for further details. * Have active infections or target knee conditions that may compromise study drug administration * Have exclusionary lab values determined during Screening * Have severe hip OA on the same side of the target knee that interferes with assessment of pain in the target knee * Have or had primarily patellofemoral OA, severe malalignment, certain knee surgeries, or other excluded target knee conditions * Have joint disorders, uncontrolled fibromyalgia, or clinically significant conditions that could interfere with study assessments or compromise participant safety * Received another clinical trial therapy, medication, or product with 90 days of Screening * Have non-compliance with study diaries during Screening * Involved in litigation, disability, or worker's compensation matters based on OA pain * Allergic to study drug, HA, placebo, or acetaminophen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline of the average daily pain intensity score. | From Baseline to Week 12 | The average daily (24 hour) pain intensity score will be measured on a numeric rating scale (NRS) ranging from 0 to 10. The Baseline value will be the mean of the daily records over the 7-day period before Day 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline to Week 12. | Change in WOMAC function subscale from Baseline to Week 12. |
Contacts
CONTACTMarta Bignamini
Outcome results
None listed