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

NCT04742907 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: TU100P2T4
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 36

Brief 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).

Conditions

Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (1)

• Time to Gastrointestinal Recovery (GIR)

  Time to achieve recovery of GI motility as measured by a composite endpoint representing upper AND lower GI recovery

  From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

Secondary Outcomes (7)

• Time to GIR Responses

  From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

• Time to Discharge

  From surgery to hospital discharge

• GIR Outcome Related to Length of Hospitalization (Mean)

  From surgery to hospital discharge

• GIR Outcome Related to Length of Hospitalization (Median)

  From surgery to hospital discharge

• Percentage of GIR Responders

  From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

Other Outcomes (4)

• Subject-Reported Occurrence of Nausea

  From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

• Subject-Reported Bothersomeness of Nausea

  From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

• Subject-Reported Occurrence of Abdominal Bloating

  From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

Study Arms (3)

TU-100 15 g/day

EXPERIMENTAL

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

TU-100 7.5 g/day

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).

Drug: Placebo

Interventions

TU-100 DRUG

Treatment with investigational product

Also known as: Daikenchuto

TU-100 15 g/day; TU-100 7.5 g/day

Placebo DRUG

Treatment with placebo product

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age
• 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
• 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 study program, and have voluntarily provided informed consent

You may not qualify if:

• Scheduled for a BR that is not listed in this protocol
• Requires any additional resections beyond the intestine (eg, hepatectomy, distal pancreatectomy, pancreaticoduodenectomy, gastric resection, uterine resection), or concomitant 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 the opinion of the investigator might confound the study results or pose additional risk in administering the study procedures
• Have a functional colostomy or ileostomy
• Diagnosed with advanced or metastatic colon cancer (Stage IV by tumor, node, and metastasis classification)
• Positive coronavirus disease 2019 (COVID-19) test
• 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
• Chronic pain syndrome unrelated to the planned surgery requiring consistent management 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 other immunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease (HIV)
• 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)
• 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

Sponsors & Collaborators

• Tsumura USA: lead

Study Sites (36)

Florence Site

Florence, Alabama, 35630, United States

Location

Gilbert Site

Gilbert, Arizona, 85234, United States

Location

Little Rock Site

Little Rock, Arkansas, 72205, United States

Location

Duarte Site

Duarte, California, 91010, United States

Location

Los Angeles Site #1

Los Angeles, California, 90033, United States

Location

Los Angeles Site #2

Los Angeles, California, 90048, United States

Location

Palo Alto Site

Palo Alto, California, 94304, United States

Location

Sacramento Site

Sacramento, California, 95817, United States

Location

Danbury Site

Danbury, Connecticut, 06810, United States

Location

Clearwater Site

Clearwater, Florida, 33756, United States

Location

Orlando Site

Orlando, Florida, 32803, United States

Location

Tampa Site

Tampa, Florida, 33606, United States

Location

Weston Site

Weston, Florida, 33331, United States

Location

Chicago Site #2

Chicago, Illinois, 60612, United States

Location

Chicago Site #1

Chicago, Illinois, 60637, United States

Location

Urbana Site

Urbana, Illinois, 61801, United States

Location

Lexington Site

Lexington, Kentucky, 40536, United States

Location

Metairie Site

Metairie, Louisiana, 70006, United States

Location

Boston Site #1

Boston, Massachusetts, 02115, United States

Location

Detroit Site

Detroit, Michigan, 48201, United States

Location

St. Louis Site

St Louis, Missouri, 63110, United States

Location

Newark Site

Newark, New Jersey, 07103, United States

Location

Mineola Site

Mineola, New York, 11501, United States

Location

New York Site

New York, New York, 10065, United States

Location

Stony Brook Site

Stony Brook, New York, 11794, United States

Location

Cleveland Site #2

Cleveland, Ohio, 44111, United States

Location

Cleveland Site #1

Cleveland, Ohio, 44195, United States

Location

Philadelphia Site #2

Philadelphia, Pennsylvania, 19140, United States

Location

Pittsburgh Site

Pittsburgh, Pennsylvania, 15212, United States

Location

Charleston Site

Charleston, South Carolina, 29425, United States

Location

Memphis Site

Memphis, Tennessee, 38120, United States

Location

Dallas Site

Dallas, Texas, 75246, United States

Location

Fort Worth Site

Fort Worth, Texas, 76104, United States

Location

Salt Lake City Site

Salt Lake City, Utah, 84132, United States

Location

Roanoke Site

Roanoke, Virginia, 24014, United States

Location

Milwaukee Site

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Nedeljkovic SS, Silinsky JD, Nagle D, Lee SW, Ayad S, Segura-Vasi AM, Fleshner PR, Choti MA, Wren SM, Kosaka B Pharm J, Tanaka Y, Li YP, 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-Blinded, Placebo-Controlled Trial. Dis Colon Rectum. 2026 Jan 1;69(1):73-86. doi: 10.1097/DCR.0000000000003990. Epub 2025 Oct 20.

  PMID: 41114550 DERIVED

MeSH Terms

Interventions

12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine; dai-kenchu-to

Results Point of Contact

• Title: Yu Tanaka, Ph.D., MBA
• Organization: Tsumura USA, Inc.

Tanaka_yuu@mail.tsumura.co.jp

609-799-2083

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 8, 2021
• Study Start: July 29, 2021
• Primary Completion: March 25, 2024
• Study Completion: May 1, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-04

Locations

US (36)