Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy

Postoperative Ileus Clinical Trial

— TU100P2T3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232893
• Other study ID #: TU100P2T3
• Status: Completed
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: May 2017

Study information

• Verified date: June 2020
• Source: Tsumura USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Atlanta Site	Atlanta	Georgia
United States	Aurora Site	Aurora	Colorado
United States	Burlington, MA Site	Burlington	Massachusetts
United States	Burlington, VT Site	Burlington	Vermont
United States	Chicago Site	Chicago	Illinois
United States	Cleveland Site	Cleveland	Ohio
United States	Coon Rapids Site	Coon Rapids	Minnesota
United States	Jackson Site	Jackson	Mississippi
United States	Los Angeles Site	Los Angeles	California
United States	Metairie Site	Metairie	Louisiana
United States	Minneapolis Site	Minneapolis	Minnesota
United States	Spokane Site	Spokane	Washington
United States	Weston Site	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Tsumura USA	Cato Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 15 days