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])
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).
Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery in Subjects Undergoing Bowel Resection
A Tolerability and Efficacy Study of TU-100 For The Treatment of Postoperative Ileus
A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome