Status:
COMPLETED
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of LG00034053 in Patients With Knee OA
Lead Sponsor:
LG Chem
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
PHASE2
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 de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2024
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT05237752
Start Date
April 27 2022
End Date
March 11 2024
Last Update
May 3 2024
Active Locations (2)
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1
Emeritus Research
Camberwell, Australia
2
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, South Korea