Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy

Completed · Phase 2 · Has a placebo group

Conditions studied: Postoperative Ileus

In brief

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.

Key facts

Study ID

NCT02232893

Run by

Tsumura USA

People needed

69

Starts

2014-09-01

Expected to finish

2017-05-01

Last updated by the study team

2020-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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