Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery in Subjects Undergoing Bowel Resection

Completed · Phase 2 · Has a placebo group

Conditions studied: Enhanced Recovery After Surgery

In brief

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).

Key facts

Study ID

NCT04742907

Run by

Tsumura USA

People needed

402

Starts

2021-07-29

Expected to finish

2024-05-01

Last updated by the study team

2025-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Florence Site — Florence, Alabama, United States
• Gilbert Site — Gilbert, Arizona, United States
• Little Rock Site — Little Rock, Arkansas, United States
• Duarte Site — Duarte, California, United States
• Los Angeles Site #1 — Los Angeles, California, United States
• Los Angeles Site #2 — Los Angeles, California, United States
• Palo Alto Site — Palo Alto, California, United States
• Sacramento Site — Sacramento, California, United States
• Danbury Site — Danbury, Connecticut, United States
• Clearwater Site — Clearwater, Florida, United States
• Orlando Site — Orlando, Florida, United States
• Tampa Site — Tampa, Florida, United States
• Weston Site — Weston, Florida, United States
• Chicago Site #2 — Chicago, Illinois, United States
• Chicago Site #1 — Chicago, Illinois, United States
• Urbana Site — Urbana, Illinois, United States
• Lexington Site — Lexington, Kentucky, United States
• Metairie Site — Metairie, Louisiana, United States
• Boston Site #1 — Boston, Massachusetts, United States
• Detroit Site — Detroit, Michigan, United States
• St. Louis Site — St Louis, Missouri, United States
• Newark Site — Newark, New Jersey, United States
• Mineola Site — Mineola, New York, United States
• New York Site — New York, New York, United States
• Stony Brook Site — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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