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

Primary Purpose

Postoperative Ileus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Daikenchuto (TU-100)
Placebo
Sponsored by
Tsumura USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus focused on measuring Gastrointestinal Quality of Life Index (GIQLI), Postoperative Quality of Life, Abdominal Bloating, Laparoscopic colectomy, Postoperative ileus (POI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Los Angeles Site
  • Aurora Site
  • Weston Site
  • Atlanta Site
  • Chicago Site
  • Metairie Site
  • Burlington, MA Site
  • Coon Rapids Site
  • Minneapolis Site
  • Jackson Site
  • Cleveland Site
  • Burlington, VT Site
  • Spokane Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Daikenchuto (TU-100)

Placebo

Arm Description

Daikenchuto (TU-100) 5g TID (15g/day)

Placebo TID

Outcomes

Primary Outcome Measures

Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4.
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.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2014
Last Updated
June 17, 2020
Sponsor
Tsumura USA
Collaborators
Cato Research
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1. Study Identification

Unique Protocol Identification Number
NCT02232893
Brief Title
Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy
Acronym
TU100P2T3
Official Title
A Randomized, Double-Blinded, Placebo-Controlled Trial of TU-100 in Patients Undergoing Laparoscopic Colectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tsumura USA
Collaborators
Cato Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
Gastrointestinal Quality of Life Index (GIQLI), Postoperative Quality of Life, Abdominal Bloating, Laparoscopic colectomy, Postoperative ileus (POI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daikenchuto (TU-100)
Arm Type
Experimental
Arm Description
Daikenchuto (TU-100) 5g TID (15g/day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo TID
Intervention Type
Drug
Intervention Name(s)
Daikenchuto (TU-100)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4.
Description
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.
Time Frame
Baseline and 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Jensen, M.D., M.P.H.
Organizational Affiliation
Colon & Rectal Surgery Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Aurora Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Weston Site
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Atlanta Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Chicago Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Metairie Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Burlington, MA Site
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Coon Rapids Site
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Minneapolis Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Jackson Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39042
Country
United States
Facility Name
Cleveland Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Burlington, VT Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Spokane Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

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Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy

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