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

April 15, 2025 updated by: Tsumura USA

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
402

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Florence, Alabama, United States, 35630
        • Florence Site
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Gilbert Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Site
    • California
      • Duarte, California, United States, 91010
        • Duarte Site
      • Los Angeles, California, United States, 90033
        • Los Angeles Site #1
      • Los Angeles, California, United States, 90048
        • Los Angeles Site #2
      • Palo Alto, California, United States, 94304
        • Palo Alto Site
      • Sacramento, California, United States, 95817
        • Sacramento Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Clearwater Site
      • Orlando, Florida, United States, 32803
        • Orlando Site
      • Tampa, Florida, United States, 33606
        • Tampa Site
      • Weston, Florida, United States, 33331
        • Weston Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Chicago Site #2
      • Chicago, Illinois, United States, 60637
        • Chicago Site #1
      • Urbana, Illinois, United States, 61801
        • Urbana Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Lexington Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Metairie Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Site #1
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Detroit Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Site
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Newark Site
    • New York
      • Mineola, New York, United States, 11501
        • Mineola Site
      • New York, New York, United States, 10065
        • New York Site
      • Stony Brook, New York, United States, 11794
        • Stony Brook Site
    • Ohio
      • Cleveland, Ohio, United States, 44111
        • Cleveland Site #2
      • Cleveland, Ohio, United States, 44195
        • Cleveland Site #1
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Philadelphia Site #2
      • Pittsburgh, Pennsylvania, United States, 15212
        • Pittsburgh Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Charleston Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Memphis Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Dallas Site
      • Fort Worth, Texas, United States, 76104
        • Fort Worth Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Salt Lake City Site
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Roanoke Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Milwaukee Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Gastrointestinal Recovery (GIR)
Time Frame: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to GIR Responses
Time Frame: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
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
From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Time to Discharge
Time Frame: From surgery to hospital 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)
From surgery to hospital discharge
GIR Outcome Related to Length of Hospitalization (Mean)
Time Frame: From surgery to hospital discharge
Mean number of days that the subject stayed in the hospital calculated based on calendar day of discharge order written
From surgery to hospital discharge
GIR Outcome Related to Length of Hospitalization (Median)
Time Frame: From surgery to hospital discharge
Median number of days that the subject stayed in the hospital calculated based on calendar day of discharge order written
From surgery to hospital discharge
Percentage of GIR Responders
Time Frame: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Percentage of subjects who achieve GIR (GIR responders) by day
From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
POI-related Morbidity
Time Frame: From the day after surgery to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
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)
From the day after surgery to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Number of Participants With Adverse Events
Time Frame: From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Number of patients with adverse events (AEs) observed following administration of TU-100.
From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subject-Reported Occurrence of Nausea
Time Frame: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Subjects will record the occurrence of nausea in their eDiaries on all postoperative in-hospital days.
From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Subject-Reported Bothersomeness of Nausea
Time Frame: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Subjects who answered that they felt nauseous will record bothersomeness of nausea in their eDiaries on all postoperative in-hospital days. Bothersomeness is measured on a scale of 0-10 with 10 being the most bothersome.
From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Subject-Reported Occurrence of Abdominal Bloating
Time Frame: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Subjects will record the occurrence of abdominal bloating in their eDiaries on all postoperative in-hospital days.
From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Subject-Reported Bothersomeness of Abdominal Bloating
Time Frame: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Subjects who answered that they felt bloated will record bothersomeness of abdominal bloating in their eDiaries on all postoperative in-hospital days. Bothersomeness is measured on a scale of 0-10 with 10 being the most bothersome.
From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tsumura USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TU100P2T4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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