/ Not yet recruiting临床4期IIT The Effect of Pregabalin on Shoulder Pain of Patients With Myofascial Pain Syndrome and Central Sensitization Who Undergo Arthroscopic Rotator Cuff Repair
This study aims to investigate the effects of Pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. Although Pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for patients with central sensitization is scarce. Utilizing a list that identifies central sensitization, this study will explore whether Pregabalin can reduce postoperative pain in these patients and potentially improve joint mobility, emotional, and physical functioning. A prospective randomized study is planned, with inclusion criteria set for patients aged between 19 and 70 who have undergone arthroscopic rotator cuff repair.
The study will compare clinical outcomes up to one year postoperatively between two groups of 38 patients each. The case group will receive standard postoperative medications (NSAIDs) plus Pregabalin oral intake from the day before surgery to six weeks postoperatively, while the control group will receive only the standard postoperative medications without Pregabalin.
POST-MARKETING SURVEILLANCE (PMS) TO OBSERVE THE SAFETY AND EFFECTIVENESS OF LYRICA(REGISTERED) CR EXTENDED RELEASE TABLETS
This is an open-label, non-comparative, non-interventional, prospective, and multi-center PMS study to observe safety and effectiveness of Lyrica CR (82.5mg, 165mg, 330mg) in Korean subjects under the actual condition of use. PMS is an obligation to K-MFDS.
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近日(11月22日),独立数据监测委员会(DMC )建议,InDex Pharmaceutical宣布停止对cobitolimod的III期临床开发。DMC在通过对其CONCLUDE系列研究中的诱导期研究进行评估后,认为该研究不太可能达到主要终点,建议其停止开发。cobitolimod是一种Toll样受体9(TLR9)激动剂,为该公司最重要的临床资产。TLR-9是Toll样受体家族的一员,是表达于免疫系统细胞,如树突状细胞、巨噬细胞以及其他抗原提呈细胞内的重要受体。TLR9可被存在于细菌和病毒DNA分子中的未甲基化的CpG序列激活,触发导致促炎细胞因子反应的信号级联反应,包括诱导IL-6、TNF、干扰素等产生。cobitolimod(单链寡核苷酸)通过模拟细菌DNA来刺激TLR9产生免疫应答,其CpG二核苷酸序列可被不同免疫细胞上的Toll样受体9识别,诱导不同的细胞因子,如IL10和IFNα,在大肠局部提供抗炎作用,诱导黏膜愈合,减轻溃疡性结肠炎的临床症状。1000万美元首付款打水漂几个月前(2023年5月31日),公司还就cobitolimod与日本Viatris达成了授权合作,Viatris获得了cobitolimod在日本开发和商业化权益,为此,Viatris Japan将向InDex支付1000万美元的预付款,以及4000万美元的销售里程碑付款、日本区的销售分成。首付款也在合作达成后不久已到账,如今临床试验终止,Viatris的这笔首付款只能打水漂了。本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处﹀···
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