Osteoarthritis, Knee
Conditions
Brief summary
This study is a multi-center, randomized, placebo-controlled, double-blind clinical study, consisting of Part 1 (Phase 1b) in a sequential, dose-escalating design and Part 2 (Phase 2) in a parallel design.
Interventions
DRUGLG00034053
a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients diagnosed with primary osteoarthritis of the knee according to the ACR clinical criteria, with Kellgren-Lawrence grade 2 to 3 in the corresponding knee as determined in the X-ray test * Patients with pain in the index knee requiring NSAIDs or analgesics which sustained for at least 6 months * Patients with a score of ≥ 4 and ≤ 9 in response to question 1 (walking pain) on the WOMAC pain subscale (11-point NRS) * Patients with the subtotal score of ≥ 20 and ≤ 45 on the WOMAC pain subscale (11- point NRS) * Patients with BMI at or below 40 kg/m2
Exclusion criteria
* Patients with chronic pain requiring continuous treatment * Patients with rheumatoid arthritis or other inflammatory arthritis * Patients with skin disorders at the administration site * Patients with clinically significant renal or cardiovascular disease or those with suspected SARS-CoV-2 infection * Patients in a medical condition which may affect the efficacy and/or safety assessment * Patients with Kellgren-Lawrence grade 4 in the contralateral knee * Patients with tense effusion * Patients having administered an opioid analgesic/ other analgesic/health functional foods, single dose of IA injection within a certain period prior to drug administration * Patients having undergone knee replacement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in WOMAC (Western Ontario and McMaster Universities Arthritis Index) (11-point NRS) pain score from baseline to time point | week 12 | Change of WOMAC (11-point NRS) pain score from baseline to Week 12 \- a total of 5 questions, each question's score is as below Mininum : 0 (no pain) Maximum : 10 (extreme pain) Higher score means worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in WOMAC score from baseline to time point | week 1 ~ week 24 | Change of WOMAC (11-point NRS) score 1. WOMAC pain score (except week 12) 2. WOMAC function, stiffness, total score * function (17 questions, scores are 0 to 170) * stiffness (2 questions, scores are 0 to 20) * total score: pain + function + stiffness = 240 at maximum Higher score means worse outcome |
| Weekly mean of the average daily pain intensity score (11-point NRS) from baseline to time point | week 1 ~ week 24 | Change in weekly mean of average daily pain intensity score (11-point NRS) \- 0 (no pain) to 10 (pain as bad as you can imagine) |
Countries
Australia, South Korea
Outcome results
None listed