A Multicenter, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled Phase I/IIa Study to Evaluate the Efficacy and Safety of a Single Intra-Articular Injection of YYD302 in Patients with Knee Osteoarthritis

被引:3
|
作者
In, Yong [1 ]
Ha, Chul-Won [2 ]
机构
[1] Catholic Univ Korea, Coll Med, Dept Orthopaed Surg, Seoul St Marys Hosp, Seoul 06591, South Korea
[2] Sungkyunkwan Univ, Samsung Med Ctr, Sch Med, Dept Orthopaed Surg,Stem Cell & Regenerat Med Ins, Seoul 06351, South Korea
关键词
osteoarthritis; hyaluronic acid; clinical trial; injection; DUROLANE HYALURONIC-ACID; CLINICAL-TRIALS; VISCOSUPPLEMENTATION; CRITERIA; HIP;
D O I
10.3390/jcm11061482
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
This study was a phase I/IIa, multicenter, randomized, double-blinded, parallel, placebo-controlled clinical trial that aimed to assess the efficacy and safety of a single intra-articular injection of YYD302, a novel high-molecular-weight hyaluronic acid with divinyl sulfone cross-linking. Thirty adults with knee osteoarthritis were randomized to receive a single 2 mL intra-articular injection of YYD302 (test group 1), 3 mL of YYD302 (test group 2), or 3 mL of the placebo (placebo group). We compared the changes from the baseline in the weight-bearing pain of 100 mm using the Visual Analog Scale (VAS), the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Rheumatology-Osteoarthritis Research Society International (OMERACT-OASRSI) responder rates, and the use of rescue analgesics to assess the safety of this novel drug. A total of 26 subjects (10 in test group 1, 10 in test group 2, and 6 in the placebo group) were included in the full analysis set. At 12 weeks, only test groups 1 and 2 showed significant changes in the weight-bearing pain VAS scores (p = 0.0015 and p = 0.0085), symptoms, and average daily KOOS values compared to the baseline (p < 0.001, p = 0.0124, and p = 0.0018, p = 0.0426, respectively). While the rate and frequency of consuming the rescue drug continued to increase in the placebo group until 12 weeks, there was no change in the test groups. Our findings showed that YYD302, especially 2 mL of YYD302, reduced pain and improved knee joint function compared to the placebo.
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页数:12
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