Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery in Subjects Und… (NCT04742907) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery in Subjects Undergoing Bowel Resection
United States402 participantsStarted 2021-07-29
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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)
What they're measuring
1
Time to Gastrointestinal Recovery (GIR)
Timeframe: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
✕. 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