維康藥業(300878.SZ):銀黃滴丸治療複發性口腔潰瘍(上焦實熱證)完成Ⅱ期臨牀試驗
格隆匯3月28日丨維康藥業(300878.SZ)公佈,公司於近日收到銀黃滴丸治療複發性口腔潰瘍(上焦實熱證)的有效性和安全性的多中心、隨機、雙盲、安慰劑平行對照Ⅱ期臨牀試驗的總結報吿。
基於銀黃滴丸Ⅱ期臨牀研究結果:用藥第5天末,銀黃滴丸高劑量組、低劑量組靶潰瘍癒合率均高於安慰劑組。用藥第5天末,銀黃滴丸高、低劑量組較安慰劑組在靶潰瘍癒合時間、口腔潰瘍癒合率、受試者自覺疼痛消失時間、潰瘍總數較基線的變化、中醫證候評分較基線的變化值有改善趨勢。銀黃滴丸高劑量組較低劑量組、安慰劑組趨勢明顯。試驗期間未發生嚴重不良事件和嚴重不良反應。II期臨牀安全性分析顯示銀黃滴丸安全性總體良好。
根據II期臨牀試驗的結果,推薦銀黃滴丸高劑量【口服,一次2袋(每袋0.7g),一日4次。】作為III期確證性試驗的目標劑量。進一步擴大樣本量確證銀黃滴丸治療複方性口腔潰瘍的有效性和安全性。
公司銀黃滴丸治療複發性口腔潰瘍(上焦實熱證)目前完成Ⅱ期臨牀試驗,距離產品上市仍需經歷III期臨牀試驗;申請銀黃滴丸增加複方性口腔潰瘍新適應症;公司目前正積極籌備該藥品後續的臨牀研究工作。
截至該公吿日,在CDE藥物臨牀試驗登記與信息公示平台上登記複發性口腔潰瘍(上焦實熱證)的試驗藥物有2個:銀黃滴丸、荊門上清丸。
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