Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy
NCT ID: NCT02232893
Last Updated: 2020-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2014-09-30
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Daikenchuto (TU-100)
Daikenchuto (TU-100) 5g TID (15g/day)
Daikenchuto (TU-100)
Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.
Placebo
Placebo TID
Placebo
Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.
Interventions
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Daikenchuto (TU-100)
Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.
Placebo
Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Cato Research
INDUSTRY
Tsumura USA
INDUSTRY
Responsible Party
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Principal Investigators
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Christine Jensen, M.D., M.P.H.
Role: PRINCIPAL_INVESTIGATOR
Colon & Rectal Surgery Associates
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TU100P2T3
Identifier Type: -
Identifier Source: org_study_id
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