TU100P2T4 Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery after Surgery (ERAS) Protocol in Subjects Undergoing Bowel Resection.

NCT04742907

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery after Surgery (ERAS) Protocol in Subjects Undergoing Bowel Resection.

Principal Investigator

Sponsor

Tsumura USA

This multicenter, randomized, double-blinded, placebo-controlled study will evaluate the effect of TU-100 on resolution of POI in subjects undergoing open or laparoscopic BR. Straight, hand-assisted, and robotically-assisted laparoscopic approaches are allowed. Subjects undergoing major abdominal resective intestinal surgeries (BRs; eg, small BR, large BR, rectal resections [low anterior resection], total colectomy with ileo-rectal anastomosis) will be eligible for enrollment.

This study is currently enrolling.