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

Last updated: April 15, 2025
Sponsor: Tsumura USA
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

Placebo

TU-100

Clinical Study ID

NCT04742907
TU100P2T4
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female ≥ 18 years of age

  2. Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP; mustbe able and willing to use at least 1 highly effective method of contraceptionduring 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 studyprogram, and have voluntarily provided informed consent

Exclusion

Exclusion Criteria:

  1. Scheduled for a BR that is not listed in this protocol

  2. Requires any additional resections beyond the intestine (eg, hepatectomy, distalpancreatectomy, pancreaticoduodenectomy, gastric resection, uterine resection), orconcomitant 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 theopinion of the investigator might confound the study results or pose additional riskin administering the study procedures

  5. Have a functional colostomy or ileostomy

  6. Diagnosed with advanced or metastatic colon cancer (Stage IV by tumor, node, andmetastasis classification)

  7. Positive coronavirus disease 2019 (COVID-19) test

  8. Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection (including human immunodeficiency virus (HIV)), diabetes, symptomaticcongestive heart failure and ejection fraction < 35%, unstable angina pectoris,cardiac arrhythmia, or psychiatric illness/social situations that would limitcompliance with protocol requirements

  9. Chronic pain syndrome unrelated to the planned surgery requiring consistentmanagement 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 otherimmunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease (HIV)

  14. Pregnant (identified by a positive serum pregnancy test) or lactating, or are notpostmenopausal (no menses for at least 1 year) and are of childbearing potential andnot using an accepted method of birth control (surgical sterilization, intrauterinecontraceptive device, oral contraceptive, diaphragm, or condom in combination withcontraceptive 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 medicaldevice study, or any study in which active subject participation is required outsideroutine hospital data collection during the course of the study

  16. Illicit drug use or alcohol abuse based on medical history, or currently engaged inillicit drug use or alcohol abuse

  17. Uses of supplemental ginger, ginseng, or Zanthoxylum fruit within 72 hours beforerandomization

  18. Has a history of allergic reactions to ginseng, ginger, Zanthoxylum fruit, orlactose

  19. Has clinical symptoms of lactose intolerance after ingesting milk or milk-containingproducts (abdominal pain, flatulence, diarrhea)

  20. Unwilling or unable to comply with procedures described in this protocol or isotherwise 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 thestudy results or pose additional risk in administering the study procedures

Study Design

Total Participants: 402
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 29, 2021
Estimated Completion Date:
May 01, 2024

Study Description

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.

Connect with a study center

  • Florence Site

    Florence, Alabama 35630
    United States

    Site Not Available

  • Gilbert Site

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Little Rock Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Duarte Site

    Duarte, California 91010
    United States

    Site Not Available

  • Los Angeles Site #1

    Los Angeles, California 90033
    United States

    Site Not Available

  • Los Angeles Site #2

    Los Angeles, California 90048
    United States

    Site Not Available

  • Palo Alto Site

    Palo Alto, California 94304
    United States

    Site Not Available

  • Sacramento Site

    Sacramento, California 95817
    United States

    Site Not Available

  • Danbury Site

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Clearwater Site

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Miami Site

    Miami, Florida 33155
    United States

    Site Not Available

  • Orlando Site

    Orlando, Florida 32803
    United States

    Site Not Available

  • Tampa Site

    Tampa, Florida 33606
    United States

    Site Not Available

  • Weston Site

    Weston, Florida 33331
    United States

    Site Not Available

  • Chicago Site #1

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Chicago Site #2

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Urbana Site

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Lexington Site

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Louisville Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Metairie Site

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Baltimore Site

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Boston Site #1

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Boston Site #2

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Detroit Site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • St. Louis Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Newark Site

    Newark, New Jersey 07103
    United States

    Site Not Available

  • Mineola Site

    Mineola, New York 11501
    United States

    Site Not Available

  • New York Site

    New York, New York 10065
    United States

    Site Not Available

  • Stony Brook Site

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Cleveland Site #1

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Site #2

    Cleveland, Ohio 44111
    United States

    Site Not Available

  • Dayton Site

    Dayton, Ohio 45409
    United States

    Site Not Available

  • Philadelphia Site #1

    Philadelphia, Pennsylvania 19141
    United States

    Site Not Available

  • Philadelphia Site #2

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Pittsburgh Site

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Charleston Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Memphis Site

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Dallas Site

    Dallas, Texas 75246
    United States

    Site Not Available

  • Fort Worth Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Salt Lake City Site

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Roanoke Site

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • Milwaukee Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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