Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery (ERAS) Protocol in Subjects Undergoing Bowel Resection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 402
- 试验地点
- 36
- 主要终点
- Time to Gastrointestinal Recovery (GIR)
研究概览
简要总结
This multicenter, randomized, double-blinded, placebo-controlled study will evaluate the effect of TU-100 on resolution of postoperative ileus (POI) in subjects undergoing open or laparoscopic bowel resection (BR).
详细描述
Subjects will be screened up to 28 days before their planned surgery and will be randomized 1:1:1 (TU-100 15 g/day: TU-100 7.5 g/day: placebo) on postoperative Day 1 before the first dose of study medication. After randomization, subjects will receive a total daily dose of TU-100 15g, TU-100 7.5 g, 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 adjunct to an enhanced recovery (ERAS) pathway for gastrointestinal (GI) recovery.
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
Investigators, study staff, sponsor designees, and subjects will be blinded to randomized study treatment for the duration of the study. The pharmacist or designee performing the preparation and administration will also be blinded.
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 ≥ 18 years of age
- •Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP; must be able and willing to use at least 1 highly effective method of contraception during the study and for 30 days after the last dose of study drug
- •American Society of Anesthesiologists Physical Status Score of 1 to 3
- •Scheduled for an elective BR via open or laparoscopic approach
- •Ability to understand the study procedures, have agreed to participate in the study program, and have voluntarily provided informed consent
排除标准
- •Scheduled for a BR that is not listed in this protocol
- •Requires any additional resections beyond the intestine (eg, hepatectomy, distal pancreatectomy, pancreaticoduodenectomy, gastric resection, uterine resection), or concomitant surgeries (with the exception of biopsies)
- •Requires the formation of a stoma (ileostomy or colostomy)
- •History of surgeries, illness, or behavior (eg, depression, psychosis) that in the opinion of the investigator might confound the study results or pose additional risk in administering the study procedures
- •Have a functional colostomy or ileostomy
- •Diagnosed with advanced or metastatic colon cancer (Stage IV by tumor, node, and metastasis classification)
- •Positive coronavirus disease 2019 (COVID-19) test
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including human immunodeficiency virus (HIV)), diabetes, symptomatic congestive heart failure and ejection fraction < 35%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements
- •Chronic pain syndrome unrelated to the planned surgery requiring consistent management with analgesics and/or other non-pharmacologic modalities
- •Myocardial infarction within 3 months
- •Corrected QT interval > 500 msec
- •Diabetic gastroparesis
- •Compromised immune system, either from treatment with corticosteroids or other immunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease (HIV)
- •Pregnant (identified by a positive serum pregnancy test) or lactating, or are not postmenopausal (no menses for at least 1 year) and are of childbearing potential and not using an accepted method of birth control (surgical sterilization, intrauterine contraceptive device, oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam or abstinence)
- •Participated in another investigational drug/biologic or medical device study within 30 days of surgery or will be enrolled in another investigational drug or medical device study, or any study in which active subject participation is required outside routine hospital data collection during the course of the study
- •Illicit drug use or alcohol abuse based on medical history, or currently engaged in illicit drug use or alcohol abuse
- •Uses of supplemental ginger, ginseng, or Zanthoxylum fruit within 72 hours before randomization
- •Has a history of allergic reactions to ginseng, ginger, Zanthoxylum fruit, or lactose
- •Has clinical symptoms of lactose intolerance after ingesting milk or milk-containing products (abdominal pain, flatulence, diarrhea)
- •Unwilling or unable to comply with procedures described in this protocol or is otherwise unacceptable for enrollment in the opinion of the investigator
- •Has a history of previous surgeries, illness (interstitial pneumonia), or behavior (depression, psychosis) that, in the opinion of the investigator, might confound the study results or pose additional risk in administering the study procedures
研究组 & 干预措施
TU-100 15 g/day
Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
干预措施: TU-100 (Drug)
TU-100 7.5 g/day
Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
干预措施: TU-100 (Drug)
Placebo
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Gastrointestinal Recovery (GIR)
时间窗: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Time to achieve recovery of GI motility as measured by a composite endpoint representing upper AND lower GI recovery
次要结局
- Time to GIR Responses(From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier))
- Time to Discharge(From surgery to hospital discharge)
- GIR Outcome Related to Length of Hospitalization (Mean)(From surgery to hospital discharge)
- GIR Outcome Related to Length of Hospitalization (Median)(From surgery to hospital discharge)
- Percentage of GIR Responders(From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier))
- POI-related Morbidity(From the day after surgery to discharge follow-up visit (30 days (+ 15 days) after hospital discharge))
- Number of Participants With Adverse Events(From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge))