Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy (TU100P2T3)

June 17, 2020 updated by: Tsumura USA

A Randomized, Double-Blinded, Placebo-Controlled Trial of TU-100 in Patients Undergoing Laparoscopic Colectomy

TU-100 is a gastrointestinal drug produced from the three botanical raw materials, Asian ginseng, Zanthoxylum fruit (Japanese pepper), and ginger, based on proprietary aqueous decoction and granulation technology. The aim of this study is to assess the effect of TU-100 on post-operative quality of life during the 4 week postoperative period after straight, hand-assisted, or robot-assisted laparoscopic colectomy. Optimal efficacy parameters for subsequent outcome studies also will be explored.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • 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 Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Los Angeles Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Aurora Site
    • Florida
      • Weston, Florida, United States, 33331
        • Weston Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Chicago Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Metairie Site
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Burlington, MA Site
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Coon Rapids Site
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Site
    • Mississippi
      • Jackson, Mississippi, United States, 39042
        • Jackson Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Cleveland Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Burlington, VT Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Spokane 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be at least 18 years of age
  • Has a current diagnosis of colon cancer, diverticulitis, or benign colonic neoplasm
  • Requires straight, hand-assisted, or robot-assisted laparoscopic colectomy
  • Requires hospitalization for surgery and recovery

Exclusion Criteria:

  • Has been diagnosed with rectal cancer, advanced or metastatic colon cancer, Crohn disease, ulcerative colitis, or volvulus
  • Requires resection of rectal lesion
  • Has received or is scheduled to receive chemotherapy during the duration of the study
  • Is a pregnant or lactating female
  • Has diabetic neuropathy
  • Has a history or presence of diabetic gastroparesis
  • Has a compromised immune system, either from treatment with corticosteroids or other immunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease (e.g., human immunodeficiency virus)
  • Has any other serious condition that might adversely affect suitability for participation in this study, such as liver disorder (including alanine aminotransferase or aspartate aminotransferase level greater than 2.5 times the upper limit of normal), kidney disorders, heart failure, blood disorders, or metabolic disorders
  • Has a history or presence of interstitial pneumonia
  • Has a history of allergic reaction to ginseng, ginger or Zanthoxylum fruit (Japanese pepper)
  • Plans to receive any abdominal irradiation
  • Is clinically lactose intolerant

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo TID
Drug: Placebo
Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.
Experimental: Daikenchuto (TU-100)
Daikenchuto (TU-100) 5g TID (15g/day)
Drug: Daikenchuto (TU-100)
Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4.
Time Frame: Baseline and 15 days
The primary endpoint was change in The Gastrointestinal Quality of Life Index (GIQLI) global score from baseline to Visit 4 (Day 15 minus baseline). The global score could range from 0 (lowest quality of life) to 144 (highest quality of life). The effect of TU-100 on the change in GIQLI global score from baseline was assessed by using an analysis of covariance (ANCOVA) model with treatment group as a fixed effect and with baseline GIQLI global score, scheduled surgical location in the colon, and solid food before/after the first flatus as covariates.
Baseline and 15 days

Collaborators and Investigators

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

Sponsor

Tsumura USA

Collaborators

Cato Research

Investigators

  • Principal Investigator: Christine Jensen, M.D., M.P.H., Colon & Rectal Surgery Associates

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

September 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

September 3, 2014

First Submitted That Met QC Criteria

September 3, 2014

First Posted (Estimate)

September 5, 2014

Study Record Updates

Last Update Posted (Actual)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TU100P2T3

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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