Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery in Subjects Undergoing Bowel Resection
NCT ID: NCT04742907
Last Updated: 2025-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
402 participants
INTERVENTIONAL
2021-07-29
2024-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
TU-100
Treatment with investigational product
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).
TU-100
Treatment with investigational product
Placebo
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo
Treatment with placebo product
Interventions
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TU-100
Treatment with investigational product
Placebo
Treatment with placebo product
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Tsumura USA
INDUSTRY
Responsible Party
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Locations
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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
Cleveland Site #2
Cleveland, Ohio, United States
Cleveland Site #1
Cleveland, Ohio, United States
Philadelphia Site #2
Philadelphia, Pennsylvania, United States
Pittsburgh Site
Pittsburgh, Pennsylvania, United States
Charleston Site
Charleston, South Carolina, United States
Memphis Site
Memphis, Tennessee, United States
Dallas Site
Dallas, Texas, United States
Fort Worth Site
Fort Worth, Texas, United States
Salt Lake City Site
Salt Lake City, Utah, United States
Roanoke Site
Roanoke, Virginia, United States
Milwaukee Site
Milwaukee, Wisconsin, United States
Countries
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References
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Nedeljkovic SS, Silinsky JD, Nagle D, Lee SW, Ayad S, Segura-Vasi AM, Fleshner PR, Choti MA, Wren SM, Jun K, Tanaka Y, Li Y, Rachfal AW, Techner LM, Gan TJ, Fichera A, Michelassi F. Evaluation of TU-100 (Daikenchuto), a Traditional Japanese Kampo Medicine, As an Adjunct to Enhanced Recovery After Surgery, for Acceleration of Gastrointestinal Recovery After Bowel Resection - Results of a Proof-of-Concept, Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial. Dis Colon Rectum. 2025 Oct 20. doi: 10.1097/DCR.0000000000003990. Online ahead of print.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TU100P2T4
Identifier Type: -
Identifier Source: org_study_id
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