NCT04742907

Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery in Subjects Undergoing Bowel Resection

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Tsumura USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, double-blinded, placebo-controlled study will evaluate the effect of TU-100 on resolution of postoperative ileus (POI) in subjects undergoing open or laparoscopic bowel resection (BR).

Detailed description

Subjects will be screened up to 28 days before their planned surgery and will be randomized 1:1:1 (TU-100 15 g/day: TU-100 7.5 g/day: placebo) on postoperative Day 1 before the first dose of study medication. After randomization, subjects will receive a total daily dose of TU-100 15g, TU-100 7.5 g, or matching placebo (3 times per day (TID)) until hospital discharge or ≤ 10 days (whichever is earlier). All subjects will be treated with study medication as adjunct to an enhanced recovery (ERAS) pathway for gastrointestinal (GI) recovery.

Conditions

• Enhanced Recovery After Surgery

Interventions

Type	Name	Description
DRUG	TU-100	Treatment with investigational product
DRUG	Placebo	Treatment with placebo product

Timeline

• Start date: 2021-07-29
• Primary completion: 2024-03-25
• Completion: 2024-05-01
• First posted: 2021-02-08
• Last updated: 2025-04-16
• Results posted: 2025-04-16

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study