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Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy

Information source: Tsumura USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Ileus

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

Phase: Phase 2

Status: Recruiting

Sponsored by: Tsumura USA

Official(s) and/or principal investigator(s):
Christine Jensen, M.D., M.P.H., Principal Investigator, Affiliation: Colon & Rectal Surgery Associates

Overall contact:
Andrew Daleus, Email: adaleus@cato.com

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 abdominal discomfort 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Quality of Life after surgery based on Gastrointestinal Quality of Life Index (GIQLI) global score

Secondary outcome:

Recovery of gastrointestinal motility as measured by time to first defecation of normal stool from the end of surgery

Postoperative GI symptoms based on GIQLI single item score and domain score

Postoperative bowel habit and abdominal discomfort based on patient's diary

Major postoperative complications

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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, volvulus, or irritable bowel syndrome

- 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)

- Has a history or plan to receive any abdominal irradiation

- Is clinically lactose intolerant

Locations and Contacts

Andrew Daleus, Email: adaleus@cato.com

Colon & Rectal Surgery Associates, Coon Rapids, Minnesota 55433, United States; Recruiting
Ruth Elling, C.C.R.P., Email: relling@crsal.org
Christine Jensen, M.D., M.P.H., Principal Investigator
Additional Information

Starting date: October 2014
Last updated: July 23, 2015

Page last updated: August 23, 2015

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