TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)

Phase 2Not Yet RecruitingNCT07765589

Tsumura USA240 enrolled

Overview

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).

Subjects will be screened for eligibility up to 28 days before their planned RC or CAWR surgery and will be randomized 1:1 (TU-100 7.5 g/day: placebo) on postoperative Day 1 before the first dose of study medication. After randomization, subjects will receive TU-100 7.5 g/day 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 adjunctive to an Enhanced Recovery After Surgery (ERAS) pathway for gastrointestinal recovery. The primary objective of the study is to compare the effect of TU-100 with placebo, in conjunction with and ERAS pathway, on the proportion of subjects achieving confirmed upper and lower GI recovery (GIR) following major abdominopelvic surgery requiring extensive manipulation and/or resection of the bowel.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Delay in GI Recovery/Postoperative Ileus (POI)

Interventions

TU-100DRUG

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.

PlaceboDRUG

Matching placebo granules similar in appearance to TU-100 and administered orally three times daily.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female participants aged 18 years or older * American Society of Anesthesiologists (ASA) Physical Status Classification I-III * Scheduled to undergo elective open or minimally invasive Radical Cystectomy (RC) with continent or incontinent urinary diversion requiring bowel resection, or open or complex minimally invasive surgery for Complex Abdominal Wall Reconstruction (CAWR) with anticipated myofascial advancement flap and mesh placement for moderate or giant hernia defects * Body mass index (BMI) ≤40 kg/m² * Women of childbearing potential and men with partners of childbearing potential must agree to use highly effective contraception * Willing and able to comply with study procedures and able to voluntarily provide informed consent Exclusion Criteria: * Not scheduled for a Radical Cystectomy (RC) or Complex Abdominal Wall Reconstruction (CAWR) procedure meeting the inclusion criteria * Known gastric or bowel obstruction * Have had or have planned gastrectomy, gastric bypass, colostomy, or ileostomy * Significant gastrointestinal motility disorders * Pregnancy or breastfeeding * Clinically significant hepatic, renal, cardiovascular, or other uncontrolled medical conditions * Immunocompromised state or recent immunosuppressive therapy

Outcomes

Primary Outcomes

Confirmed Gastrointestinal Recovery (GIR) Response by postoperative day (POD) 3

Proportion of subjects achieving gastrointestinal recovery (\[first toleration of solids\] and \[first spontaneous bowel movement or 1st consistent flatus\]; GIR) by POD 3 without a subsequent serious adverse event (SAE) of primary POI.

Time frame: Postoperative Day 3

Secondary Outcomes

Confirmed GI-2 Recovery Response by POD 4

Proportion of subjects achieving first toleration of solids and first spontaneous bowel movement (GI-2 recovery) by POD 4 without a subsequent SAE of primary POI.

Time frame: Postoperative Day 4

Time to Gastrointestinal Recovery (GIR)

Time from the end of surgery to confirmed GIR, defined as first toleration of solid food and first spontaneous bowel movement or first consistent flatus.

Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first

Proportion of subjects who achieve confirmed GIR by each postoperative day

Percentage of subjects achieving confirmed GIR, defined as first toleration of solid food and first spontaneous bowel movement or first consistent flatus, without a subsequent SAE of primary POI.

Time frame: Postoperative Days 1-10

Time to GI-2 Recovery

Time from the end of surgery to GI-2 recovery, defined as first toleration of solid food and first spontaneous bowel movement.

Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first

Proportion of subjects who achieve GI-2 recovery by each postoperative day

Percentage of subjects achieving GI-2 recovery, defined as first toleration of solid food and first spontaneous bowel movement.

Central Contacts

Tomoyuki Hashiguchi, Director, Clinical Development

CONTACT

609-799-2093 hashiguchi_tomoyuki@mail.tsumura.co.jp

Data from ClinicalTrials.gov

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