Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

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

Details

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.

Keywords

Enhanced Recovery After Surgery, TU-100 15 g/day, TU-100 7.5 g/day

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Male or female ≥ 18 years of age
  2. 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
  3. American Society of Anesthesiologists Physical Status Score of 1 to 3
  4. Scheduled for an elective BR via open or laparoscopic approach
  5. Ability to understand the study procedures, have agreed to participate in the study program, and have voluntarily provided informed consent

You CAN'T join if...

  1. Scheduled for a BR that is not listed in this protocol
  2. Requires any additional resections beyond the intestine (eg, hepatectomy, distal pancreatectomy, pancreaticoduodenectomy, gastric resection, uterine resection), or concomitant surgeries (with the exception of biopsies)
  3. Requires the formation of a stoma (ileostomy or colostomy)
  4. 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
  5. Have a functional colostomy or ileostomy
  6. Diagnosed with advanced or metastatic colon cancer (Stage IV by tumor, node, and metastasis classification)
  7. Positive coronavirus disease 2019 (COVID-19) test
  8. 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
  9. Chronic pain syndrome unrelated to the planned surgery requiring consistent management with analgesics and/or other non-pharmacologic modalities
  10. . Myocardial infarction within 3 months
  11. . Corrected QT interval > 500 msec
  12. . Diabetic gastroparesis
  13. . Compromised immune system, either from treatment with corticosteroids or other immunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease (HIV)
  14. . 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)
  15. . 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
  16. . Illicit drug use or alcohol abuse based on medical history, or currently engaged in illicit drug use or alcohol abuse
  17. . Uses of supplemental ginger, ginseng, or Zanthoxylum fruit within 72 hours before randomization
  18. . Has a history of allergic reactions to ginseng, ginger, Zanthoxylum fruit, or lactose
  19. . Has clinical symptoms of lactose intolerance after ingesting milk or milk-containing products (abdominal pain, flatulence, diarrhea)
  20. . Unwilling or unable to comply with procedures described in this protocol or is otherwise unacceptable for enrollment in the opinion of the investigator
  21. . 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

Locations

  • Sacramento Site accepting new patients
    Sacramento California 95817 United States
  • Palo Alto Site accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tsumura USA
Links
Sign up for this study
ID
NCT04742907
Phase
Phase 2 Enhanced Recovery After Surgery Research Study
Study Type
Interventional
Participants
Expecting 402 study participants
Last Updated