Clinical trial NCT02232893: Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy
Official title: A Randomized, Double-Blinded, Placebo-Controlled Trial of TU-100 in Patients Undergoing Laparoscopic Colectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Ileus
Keywords: Gastrointestinal Quality of Life Index (GIQLI)
Postoperative Quality of Life
Abdominal Bloating
Laparoscopic colectomy
Postoperative ileus (POI)
Lead sponsor: Tsumura USA
Sponsor class: INDUSTRY
Collaborators: name: Cato Research
First posted: 2014-09-05
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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, 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

Primary outcomes:
measure: Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4.
timeFrame: Baseline and 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Site
state: California
city: Aurora
country: United States
facility: Aurora Site
state: Colorado
city: Weston
country: United States
facility: Weston Site
state: Florida
city: Atlanta
country: United States
facility: Atlanta Site
state: Georgia
city: Chicago
country: United States
facility: Chicago Site
state: Illinois
city: Metairie
country: United States
facility: Metairie Site
state: Louisiana
city: Burlington
country: United States
facility: Burlington, MA Site
state: Massachusetts
city: Coon Rapids
country: United States
facility: Coon Rapids Site
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Site
state: Minnesota
city: Jackson
country: United States
facility: Jackson Site
state: Mississippi
city: Cleveland
country: United States
facility: Cleveland Site
state: Ohio
city: Burlington
country: United States
facility: Burlington, VT Site
state: Vermont
city: Spokane
country: United States
facility: Spokane Site
state: Washington
Study officials:
affiliation: Colon & Rectal Surgery Associates
name: Christine Jensen, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: