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

Tsumura

Status and phase: Completed; Phase 2

Conditions: Postoperative Ileus

Treatments: Drug: Placebo; Drug: Daikenchuto (TU-100)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02232893

TU100P2T3

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 2 patient groups, including a placebo group

Daikenchuto (TU-100)

Experimental group

Description:

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

Treatment:

Drug: Daikenchuto (TU-100)

Placebo

Placebo Comparator group

Description:

Placebo TID

Treatment:

Drug: Placebo