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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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

Exclusion Criteria

  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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized, Double-Blind, Placebo-Controlled
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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).
  • Drug: TU-100
    Treatment with investigational product
    Other names:
    • Daikenchuto
Experimental
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).
  • Drug: TU-100
    Treatment with investigational product
    Other names:
    • Daikenchuto
Placebo Comparator
Placebo 		Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
  • Drug: Placebo
    Treatment with placebo product

Recruiting Locations

Florence Site
Florence, Alabama 35630

Gilbert Site
Gilbert, Arizona 85234

Little Rock Site
Little Rock, Arkansas 72205

Duarte Site
Duarte, California 91010

Los Angeles Site #1
Los Angeles, California 90033

Los Angeles Site #2
Los Angeles, California 90048

Palo Alto Site
Palo Alto, California 94304

Sacramento Site
Sacramento, California 95817

Danbury Site
Danbury, Connecticut 06810

Clearwater Site
Clearwater, Florida 33756

Orlando Site
Orlando, Florida 32803

Tampa Site
Tampa, Florida 33606

Weston Site
Weston, Florida 33331

Chicago Site #2
Chicago, Illinois 60612

Chicago Site #1
Chicago, Illinois 60637

Urbana Site
Urbana, Illinois 61801

Lexington Site
Lexington, Kentucky 40536

Metairie Site
Metairie, Louisiana 70006

Boston Site #1
Boston, Massachusetts 02115

Detroit Site
Detroit, Michigan 48201

St. Louis Site
Saint Louis, Missouri 63110

Mineola Site
Mineola, New York 11501

New York Site
New York, New York 10065

Stony Brook Site
Stony Brook, New York 11794

Cleveland Site #2
Cleveland, Ohio 44111

Cleveland Site #1
Cleveland, Ohio 44195

Philadelphia Site #2
Philadelphia, Pennsylvania 19140

Pittsburgh Site
Pittsburgh, Pennsylvania 15212

Charleston Site
Charleston, South Carolina 29425

Memphis Site
Memphis, Tennessee 38120

Fort Worth Site
Fort Worth, Texas 76104

Salt Lake City Site
Salt Lake City, Utah 84132

Roanoke Site
Roanoke, Virginia 24014

Milwaukee Site
Milwaukee, Wisconsin 53226

More Details

NCT ID
NCT04742907
Status
Recruiting
Sponsor
Tsumura USA

Study Contact

Rebekah McLaughlin
919-341-3318
rebecca.mclaughlin@syneoshealth.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.