Status:
COMPLETED
Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy
Lead Sponsor:
Tsumura USA
Collaborating Sponsors:
Cato Research
Conditions:
Postoperative Ileus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 granulatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT02232893
Start Date
September 1 2014
End Date
May 1 2017
Last Update
June 19 2020
Active Locations (13)
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1
Los Angeles Site
Los Angeles, California, United States, 90048
2
Aurora Site
Aurora, Colorado, United States, 80045
3
Weston Site
Weston, Florida, United States, 33331
4
Atlanta Site
Atlanta, Georgia, United States, 30342