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Enhanced Recovery After SurgeryPhase 2NCT04742907

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

A Phase 2 study testing TU-100 in people with Enhanced Recovery After Surgery, run by Tsumura USA at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Enhanced Recovery After Surgery
What is being tested?
TU-100
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
402 participants
Where
36 sitesUnited States
Study dates
29 Jul 2021to 1 May 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 21Show fewer
  • 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
  • Illicit drug use or alcohol abuse based on medical history, or currently engaged in illicit drug use or alcohol abuse
  • Uses of supplemental ginger, ginseng, or Zanthoxylum fruit within 72 hours before randomization
  • Has a history of allergic reactions to ginseng, ginger, Zanthoxylum fruit, or lactose
  • Has clinical symptoms of lactose intolerance after ingesting milk or milk-containing products (abdominal pain, flatulence, diarrhea)
  • Unwilling or unable to comply with procedures described in this protocol or is otherwise 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 the study results or pose additional risk in administering the study procedures

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Boston Site #1

    Boston, Massachusetts, 02115

  • Charleston Site

    Charleston, South Carolina, 29425

  • Chicago Site #2

    Chicago, Illinois, 60612

  • Chicago Site #1

    Chicago, Illinois, 60637

  • Clearwater Site

    Clearwater, Florida, 33756

  • Cleveland Site #2

    Cleveland, Ohio, 44111

  • Cleveland Site #1

    Cleveland, Ohio, 44195

  • Dallas Site

    Dallas, Texas, 75246

  • Danbury Site

    Danbury, Connecticut, 06810

  • Detroit Site

    Detroit, Michigan, 48201

  • Duarte Site

    Duarte, California, 91010

  • Florence Site

    Florence, Alabama, 35630

  • Fort Worth Site

    Fort Worth, Texas, 76104

  • Gilbert Site

    Gilbert, Arizona, 85234

  • Lexington Site

    Lexington, Kentucky, 40536

  • Little Rock Site

    Little Rock, Arkansas, 72205

  • Los Angeles Site #1

    Los Angeles, California, 90033

  • Los Angeles Site #2

    Los Angeles, California, 90048

  • Memphis Site

    Memphis, Tennessee, 38120

  • Metairie Site

    Metairie, Louisiana, 70006

  • Milwaukee Site

    Milwaukee, Wisconsin, 53226

  • Mineola Site

    Mineola, New York, 11501

  • New York Site

    New York, New York, 10065

  • Newark Site

    Newark, New Jersey, 07103

  • Orlando Site

    Orlando, Florida, 32803

  • Palo Alto Site

    Palo Alto, California, 94304

  • Philadelphia Site #2

    Philadelphia, Pennsylvania, 19140

  • Pittsburgh Site

    Pittsburgh, Pennsylvania, 15212

  • Roanoke Site

    Roanoke, Virginia, 24014

  • Sacramento Site

    Sacramento, California, 95817

  • Salt Lake City Site

    Salt Lake City, Utah, 84132

  • St. Louis Site

    St Louis, Missouri, 63110

  • Stony Brook Site

    Stony Brook, New York, 11794

  • Tampa Site

    Tampa, Florida, 33606

  • Urbana Site

    Urbana, Illinois, 61801

  • Weston Site

    Weston, Florida, 33331

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery (ERAS) Protocol in Subjects Undergoing Bowel Resection

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).

Read the 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.

Being tested
TU-100, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TU-100Drug

    Also called Daikenchuto

    Treatment with investigational product

  • PlaceboDrug

    Treatment with placebo product

Study groups in NCT04742907
Study groupRoleWhat they receive
TU-100 15 g/dayExperimentalSubjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
Receives: Drug: TU-100
TU-100 7.5 g/dayExperimentalSubjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
Receives: Drug: TU-100
PlaceboPlacebo comparatorSubjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (7)

  1. Time to GIR Responses

    Time to achieve first toleration of solid diet AND first bowel movement (Time to GI-2), time to first toleration of clear liquids, and time to absence of distension and presence of bowel sounds and flatus

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

  2. Time to Discharge

    Time at which the subject is considered ready for discharge by the investigator based solely on GI recovery (Time to ready for discharge), and time at which the investigator writes discharge order for the subject (Time to discharge order written)

    Measured: From surgery to hospital discharge

  3. GIR Outcome Related to Length of Hospitalization (Mean)

    Mean number of days that the subject stayed in the hospital calculated based on calendar day of discharge order written

    Measured: From surgery to hospital discharge

  4. GIR Outcome Related to Length of Hospitalization (Median)

    Median number of days that the subject stayed in the hospital calculated based on calendar day of discharge order written

    Measured: From surgery to hospital discharge

  5. Percentage of GIR Responders

    Percentage of subjects who achieve GIR (GIR responders) by day

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

  6. POI-related Morbidity

    Primary POI that is not secondary to surgical complication, such as anastomotic leak, abscess formation, or sepsis that requires readmission within 7 days of discharge, or need for postoperative nasal gastric tube insertion to manage symptoms of POI (vomiting/retching, abdominal distension)

    Measured: From the day after surgery to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)

  7. Number of Participants With Adverse Events

    Number of patients with adverse events (AEs) observed following administration of TU-100.

    Measured: From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2021
  2. Study start29 Jul 2021
  3. Primary completion25 Mar 2024
  4. Study completion1 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-Blind, Placebo-Controlled
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04742907
Sponsor's protocol ID
TU100P2T4
Status last verified
Apr 2025
First submitted
29 Jan 2021
Last updated
16 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 41114550

  • Ezoe A, Shimada Y, Sawada R, Douke A, Shibata T, Kadowaki M, Yamanishi Y. Pathway-based prediction of the therapeutic effects and mode of action of custom-made multiherbal medicines. Mol Inform. 2024 Nov;43(11):e202400108. doi: 10.1002/minf.202400108. Epub 2024 Oct 15.

    PubMed 39404192

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TU-100 in people with Enhanced Recovery After Surgery, run by Tsumura USA at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Gastrointestinal Recovery (GIR) (time frame: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04742907, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.

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