Phase
Condition
N/ATreatment
Placebo
TU-100
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female ≥ 18 years of age
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
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 studyprogram, and have voluntarily provided informed consent
Exclusion
Exclusion Criteria:
Scheduled for a BR that is not listed in this protocol
Requires any additional resections beyond the intestine (eg, hepatectomy, distalpancreatectomy, pancreaticoduodenectomy, gastric resection, uterine resection), orconcomitant 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 theopinion of the investigator might confound the study results or pose additional riskin administering the study procedures
Have a functional colostomy or ileostomy
Diagnosed with advanced or metastatic colon cancer (Stage IV by tumor, node, andmetastasis classification)
Positive coronavirus disease 2019 (COVID-19) test
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
Chronic pain syndrome unrelated to the planned surgery requiring consistentmanagement 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 otherimmunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease (HIV)
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)
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
Illicit drug use or alcohol abuse based on medical history, or currently engaged inillicit drug use or alcohol abuse
Uses of supplemental ginger, ginseng, or Zanthoxylum fruit within 72 hours beforerandomization
Has a history of allergic reactions to ginseng, ginger, Zanthoxylum fruit, orlactose
Has clinical symptoms of lactose intolerance after ingesting milk or milk-containingproducts (abdominal pain, flatulence, diarrhea)
Unwilling or unable to comply with procedures described in this protocol or isotherwise 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 thestudy results or pose additional risk in administering the study procedures
Study Design
Study Description
Connect with a study center
Florence Site
Florence, Alabama 35630
United StatesSite Not Available
Gilbert Site
Gilbert, Arizona 85234
United StatesSite Not Available
Little Rock Site
Little Rock, Arkansas 72205
United StatesSite Not Available
Duarte Site
Duarte, California 91010
United StatesSite Not Available
Los Angeles Site #1
Los Angeles, California 90033
United StatesSite Not Available
Los Angeles Site #2
Los Angeles, California 90048
United StatesSite Not Available
Palo Alto Site
Palo Alto, California 94304
United StatesSite Not Available
Sacramento Site
Sacramento, California 95817
United StatesSite Not Available
Danbury Site
Danbury, Connecticut 06810
United StatesSite Not Available
Clearwater Site
Clearwater, Florida 33756
United StatesSite Not Available
Miami Site
Miami, Florida 33155
United StatesSite Not Available
Orlando Site
Orlando, Florida 32803
United StatesSite Not Available
Tampa Site
Tampa, Florida 33606
United StatesSite Not Available
Weston Site
Weston, Florida 33331
United StatesSite Not Available
Chicago Site #1
Chicago, Illinois 60637
United StatesSite Not Available
Chicago Site #2
Chicago, Illinois 60612
United StatesSite Not Available
Urbana Site
Urbana, Illinois 61801
United StatesSite Not Available
Lexington Site
Lexington, Kentucky 40536
United StatesSite Not Available
Louisville Site
Louisville, Kentucky 40202
United StatesSite Not Available
Metairie Site
Metairie, Louisiana 70006
United StatesSite Not Available
Baltimore Site
Baltimore, Maryland 21237
United StatesSite Not Available
Boston Site #1
Boston, Massachusetts 02115
United StatesSite Not Available
Boston Site #2
Boston, Massachusetts 02114
United StatesSite Not Available
Detroit Site
Detroit, Michigan 48201
United StatesSite Not Available
St. Louis Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Newark Site
Newark, New Jersey 07103
United StatesSite Not Available
Mineola Site
Mineola, New York 11501
United StatesSite Not Available
New York Site
New York, New York 10065
United StatesSite Not Available
Stony Brook Site
Stony Brook, New York 11794
United StatesSite Not Available
Cleveland Site #1
Cleveland, Ohio 44195
United StatesSite Not Available
Cleveland Site #2
Cleveland, Ohio 44111
United StatesSite Not Available
Dayton Site
Dayton, Ohio 45409
United StatesSite Not Available
Philadelphia Site #1
Philadelphia, Pennsylvania 19141
United StatesSite Not Available
Philadelphia Site #2
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Pittsburgh Site
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Charleston Site
Charleston, South Carolina 29425
United StatesSite Not Available
Memphis Site
Memphis, Tennessee 38120
United StatesSite Not Available
Dallas Site
Dallas, Texas 75246
United StatesSite Not Available
Fort Worth Site
Fort Worth, Texas 76104
United StatesSite Not Available
Salt Lake City Site
Salt Lake City, Utah 84132
United StatesSite Not Available
Roanoke Site
Roanoke, Virginia 24014
United StatesSite Not Available
Milwaukee Site
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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