Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100, Adjunctive to an Enhanced Recovery After Surgery (ERAS) Pathway, to Accelerate Gastrointestinal Recovery in Subjects Undergoing Major Abdominopelvic Surgery (Radical Cystectomy [RC] and Complex Abdominal Wall Reconstruction [CAWR])
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- Confirmed Gastrointestinal Recovery (GIR) Response by postoperative day (POD) 3
研究概览
简要总结
This Phase 2, multicenter, randomized, double-blind, placebo-controlled master protocol study will evaluate the safety and efficacy of TU-100, adjunctive to an Enhanced Recovery After Surgery (ERAS) pathway, for accelerating gastrointestinal recovery following major abdominopelvic surgery. TU-100 will be evaluated in 2 surgical populations under a Master Protocol: 1. Subjects undergoing Radical Cystectomy (RC), 2.subjects undergoing Complex Abdominal Wall Reconstruction (CAWR).
详细描述
Subjects will be screened for eligibility up to 28 days before their planned RC or CAWR surgery and will be randomized 1:1 (TU-100 7.5 g/day: placebo) on postoperative Day 1 before the first dose of study medication. After randomization, subjects will receive TU-100 7.5 g/day or matching placebo (3 times per day (TID)) until hospital discharge or ≤ 10 days (whichever is earlier). All subjects will be treated with study medication as adjunctive to an Enhanced Recovery After Surgery (ERAS) pathway for gastrointestinal recovery. The primary objective of the study is to compare the effect of TU-100 with placebo, in conjunction with and ERAS pathway, on the proportion of subjects achieving confirmed upper and lower GI recovery (GIR) following major abdominopelvic surgery requiring extensive manipulation and/or resection of the bowel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants, investigators, study staff, sponsor designees, clinical endpoint adjudication committee (CEAC), and study treatment administrators will remain blinded to treatment assignment. Participants will be randomized 1:1 to receive TU-100 7.5 g/day or matching placebo. An independent statistical group supporting DSMB reviews will be unblinded. Emergency unblinding is permitted when required for subject safety.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 18 years or older
- •American Society of Anesthesiologists (ASA) Physical Status Classification I-III
- •Scheduled to undergo elective open or minimally invasive Radical Cystectomy (RC) with continent or incontinent urinary diversion requiring bowel resection, or open or complex minimally invasive surgery for Complex Abdominal Wall Reconstruction (CAWR) with anticipated myofascial advancement flap and mesh placement for moderate or giant hernia defects
- •Body mass index (BMI) ≤40 kg/m²
- •Women of childbearing potential and men with partners of childbearing potential must agree to use highly effective contraception
- •Willing and able to comply with study procedures and able to voluntarily provide informed consent
排除标准
- •Not scheduled for a Radical Cystectomy (RC) or Complex Abdominal Wall Reconstruction (CAWR) procedure meeting the inclusion criteria
- •Known gastric or bowel obstruction
- •Have had or have planned gastrectomy, gastric bypass, colostomy, or ileostomy
- •Significant gastrointestinal motility disorders
- •Pregnancy or breastfeeding
- •Clinically significant hepatic, renal, cardiovascular, or other uncontrolled medical conditions
- •Immunocompromised state or recent immunosuppressive therapy
研究组 & 干预措施
TU-100 7.5 g/day
Subjects will receive a daily dose of TU-100 7.5 g (2.5 g TID) until hospital discharge or ≤ 10 days after surgery(whichever is earlier).
干预措施: TU-100 (Drug)
Placebo
Subjects will receive placebo TID until hospital discharge or ≤ 10 days after surgery (whichever is earlier).
干预措施: Placebo (Drug)
结局指标
主要结局
Confirmed Gastrointestinal Recovery (GIR) Response by postoperative day (POD) 3
时间窗: Postoperative Day 3
Proportion of subjects achieving gastrointestinal recovery (\[first toleration of solids\] and \[first spontaneous bowel movement or 1st consistent flatus\]; GIR) by POD 3 without a subsequent serious adverse event (SAE) of primary POI.
次要结局
- Confirmed GI-2 Recovery Response by POD 4(Postoperative Day 4)
- Time to Gastrointestinal Recovery (GIR)(From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first)
- Proportion of subjects who achieve confirmed GIR by each postoperative day(Postoperative Days 1-10)
- Time to GI-2 Recovery(From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first)
- Proportion of subjects who achieve GI-2 recovery by each postoperative day(Postoperative Days 1-10)
- Length of Hospital Stay(From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first)
- Occurrence of Nausea, Vomiting and/or Retching, and Abdominal Bloating(Postoperative Days 1-10)
- Bothersomeness of Nausea and Abdominal Bloating(Postoperative Days 1-10)
- Average of Abdominal Pain(Postoperative Days 1-10)
- Time to ready for discharge(From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first)
- Time to discharge order written(From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first)
- Time to actual hospital discharge(From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first)
- Time to first consistent flatus(From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first)
- Time to First Spontaneous Bowel Movement(From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first)
- Time to Toleration of Solid Food(From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first)