Effect 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.

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Key information

Conditions

Postoperative Ileus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Los Angeles Site, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DAIKENCHUTO (TU-100)

Drug

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.

Placebo

Drug

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Tsumura USA

Industry

Collaborators

Cato Research

Registry information

Official study title

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

Acronym: TU100P2T3

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Sep 5, 2014
Registry last updated: Jun 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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