Abstract：
BACKGROUND: Felcisetrag (5-hydroxytryptamine-4 receptor [5-HT4] agonist) is under investigation as prophylaxis or active treatment for accelerating resolution of gastrointestinal function post-surgery.
METHODS: Phase 2, randomized, placebo-controlled, parallel five-arm, double-blind, multicenter study (NCT03827655) in 209 adults undergoing open or laparoscopic-assisted bowel surgery. Patients received intravenous placebo, felcisetrag 0.1 mg/100 mL or 0.5 mg/100 mL pre-surgery only, or pre-surgery and daily post-surgery until return of gastrointestinal function or for up to 10 days.
METHODS: time to recovery of gastrointestinal function.
RESULTS: Median time to recovery of gastrointestinal function was 2.6 days for both felcisetrag 0.5 mg daily and 0.5 mg pre-surgery versus 1.9 days for placebo (p > 0.05). There were no notable differences in adverse events between treatment arms.
CONCLUSIONS: Felcisetrag was well tolerated with no new safety concerns. However, no clinically meaningful difference in time to recovery of gastrointestinal function versus placebo was observed. Further investigation of the utility of 5-HT4 agonists in complicated, open abdominal surgeries may be warranted.
METHODS: Phase 2, randomized, placebo-controlled, parallel five-arm, double-blind, multicenter study (NCT03827655) in 209 adults undergoing open or laparoscopic-assisted bowel surgery. Patients received intravenous placebo, felcisetrag 0.1 mg/100 mL or 0.5 mg/100 mL pre-surgery only, or pre-surgery and daily post-surgery until return of gastrointestinal function or for up to 10 days.
METHODS: time to recovery of gastrointestinal function.
RESULTS: Median time to recovery of gastrointestinal function was 2.6 days for both felcisetrag 0.5 mg daily and 0.5 mg pre-surgery versus 1.9 days for placebo (p > 0.05). There were no notable differences in adverse events between treatment arms.
CONCLUSIONS: Felcisetrag was well tolerated with no new safety concerns. However, no clinically meaningful difference in time to recovery of gastrointestinal function versus placebo was observed. Further investigation of the utility of 5-HT4 agonists in complicated, open abdominal surgeries may be warranted.
摘要：
背景：Felcisetrag（5-羟色胺-4受体[5-HT4]激动剂）正在研究作为预防或积极治疗以加速术后胃肠功能的消退。
方法：第二阶段，随机，安慰剂对照,平行五臂，双盲,多中心研究（NCT03827655）在209名成年人中接受开放或腹腔镜辅助肠手术。患者接受静脉注射安慰剂，felcisetrag0.1毫克/100毫升或0.5毫克/100毫升手术前，或手术前和手术后每天直到胃肠功能恢复或长达10天。
方法：胃肠功能恢复时间。
结果：手术前0.5mg的felcitetrag和0.5mg的胃肠功能恢复的中位时间为2.6天，而安慰剂为1.9天（p>0.05）。治疗组之间的不良事件没有显着差异。
结论：Felcisetrag耐受性良好，没有新的安全性问题。然而,与安慰剂相比,在胃肠功能恢复时间上没有观察到有临床意义的差异.进一步研究5-HT4激动剂在复杂，可能需要进行腹部开放手术。
方法：第二阶段，随机，安慰剂对照,平行五臂，双盲,多中心研究（NCT03827655）在209名成年人中接受开放或腹腔镜辅助肠手术。患者接受静脉注射安慰剂，felcisetrag0.1毫克/100毫升或0.5毫克/100毫升手术前，或手术前和手术后每天直到胃肠功能恢复或长达10天。
方法：胃肠功能恢复时间。
结果：手术前0.5mg的felcitetrag和0.5mg的胃肠功能恢复的中位时间为2.6天，而安慰剂为1.9天（p>0.05）。治疗组之间的不良事件没有显着差异。
结论：Felcisetrag耐受性良好，没有新的安全性问题。然而,与安慰剂相比,在胃肠功能恢复时间上没有观察到有临床意义的差异.进一步研究5-HT4激动剂在复杂，可能需要进行腹部开放手术。
