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TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)
Sponsor: Tsumura USA
Summary
This Phase 2, multicenter, randomized, double-blind, placebo-controlled master protocol study will evaluate the safety and efficacy of TU-100, adjunctive to an Enhanced Recovery After Surgery (ERAS) pathway, for accelerating gastrointestinal recovery following major abdominopelvic surgery. TU-100 will be evaluated in 2 surgical populations under a Master Protocol: 1. Subjects undergoing Radical Cystectomy (RC), 2.subjects undergoing Complex Abdominal Wall Reconstruction (CAWR).
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100, Adjunctive to an Enhanced Recovery After Surgery (ERAS) Pathway, to Accelerate Gastrointestinal Recovery in Subjects Undergoing Major Abdominopelvic Surgery (Radical Cystectomy [RC] and Complex Abdominal Wall Reconstruction [CAWR])
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-12
Completion Date
2028-07
Last Updated
2026-08-14
Healthy Volunteers
No
Interventions
TU-100
TU-100 is a traditional Japanese herbal medicine consisting of processed ginger, ginseng, and Japanese pepper (Zanthoxylum fruit). Participants will receive 7.5 g/day orally administered as 2.5 g three times daily.
Placebo
Matching placebo granules similar in appearance to TU-100 and administered orally three times daily.