Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy

NCT02232893 | Completed Phase 2 Results DMC

• 1 other identifier: TU100P2T3
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 13

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.

Conditions

Postoperative Ileus

Keywords

Gastrointestinal Quality of Life Index (GIQLI); Postoperative Quality of Life; Abdominal Bloating; Laparoscopic colectomy; Postoperative ileus (POI)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Daikenchuto (TU-100)

EXPERIMENTAL

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

Drug: Daikenchuto (TU-100)

Placebo

PLACEBO COMPARATOR

Placebo TID

Drug: Placebo

Interventions

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.

Daikenchuto (TU-100)

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tsumura USA: lead
• Cato Research: collaborator

Study Sites (13)

Los Angeles Site

Los Angeles, California, 90048, United States

Location

Aurora Site

Aurora, Colorado, 80045, United States

Location

Weston Site

Weston, Florida, 33331, United States

Location

Atlanta Site

Atlanta, Georgia, 30342, United States

Location

Chicago Site

Chicago, Illinois, 60637, United States

Location

Metairie Site

Metairie, Louisiana, 70006, United States

Location

Burlington, MA Site

Burlington, Massachusetts, 01805, United States

Location

Coon Rapids Site

Coon Rapids, Minnesota, 55433, United States

Location

Minneapolis Site

Minneapolis, Minnesota, 55407, United States

Location

Jackson Site

Jackson, Mississippi, 39042, United States

Location

Cleveland Site

Cleveland, Ohio, 44106, United States

Location

Burlington, VT Site

Burlington, Vermont, 05401, United States

Location

Spokane Site

Spokane, Washington, 99204, United States

Location

MeSH Terms

Interventions

dai-kenchu-to; 12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine

Results Point of Contact

• Title: Yu Tanaka
• Organization: Tsumura USA Inc

Yu Tanaka <tanaka_yuu@mail.tsumura.co.jp>

609-799-2083

Study Officials

• Christine Jensen, M.D., M.P.H.

  Colon & Rectal Surgery Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 5, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 19, 2020
• Results First Posted: June 19, 2020

Record last verified: 2020-06

Locations

US (13)