An Open-label, Single Arm, Multi-center, Phase 3 Study to Evaluate the Safety and Efficacy of Retreatment With Intra-articular LBSA0103 Injections in the Patients With Osteoarthritis of the Knee
Abstract
To assess the safety and efficacy of LBSA0103 (BDDE cross-linked sodium hyaluronate gel) when it is administered for the second time 26 weeks after its first administration in patients with osteoarthritis of the knee.
The Safety and efficacy of 26weeks after its first administration will be also evaluated.
Conditions: Osteoarthritis of Knee.
Primary outcome: Adverse events for 13 weeks after the first and second administration.
Enrollment: 174 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 174 participants or records.
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