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

NCT07765589 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TU100P2T5
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Delay in GI Recovery/Postoperative Ileus (POI)

Keywords

TU-100; Daikenchuto; Kampo Medicine; Enhanced Recovery After Surgery; ERAS; Postoperative Ileus; Gastrointestinal Recovery; Radical Cystectomy; Complex Abdominal Wall Reconstruction; Abdominal Surgery; Major Abdominopelvic Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative Day 3

Secondary Outcomes (15)

• Confirmed GI-2 Recovery Response by POD 4

  Postoperative Day 4

• Time to Gastrointestinal Recovery (GIR)

  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

  Postoperative Days 1-10

• Time to GI-2 Recovery

  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

  Postoperative Days 1-10

Study Arms (2)

TU-100 7.5 g/day

EXPERIMENTAL

Subjects will receive a daily dose of TU-100 7.5 g (2.5 g TID) until hospital discharge or ≤ 10 days after surgery(whichever is earlier).

Drug: TU-100

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo TID until hospital discharge or ≤ 10 days after surgery (whichever is earlier).

Drug: Placebo

Interventions

TU-100 DRUG

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.

TU-100 7.5 g/day

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tsumura USA: lead

MeSH Terms

Interventions

12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine

Study Officials

• Tomoyuki Hashiguchi, Director, Clinical Development

  Tsumura USA

  STUDY DIRECTOR

Central Study Contacts

Tomoyuki Hashiguchi, Director, Clinical Development

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants, investigators, study staff, sponsor designees, clinical endpoint adjudication committee (CEAC), and study treatment administrators will remain blinded to treatment assignment. Participants will be randomized 1:1 to receive TU-100 7.5 g/day or matching placebo. An independent statistical group supporting DSMB reviews will be unblinded. Emergency unblinding is permitted when required for subject safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This Phase 2 multicenter master protocol consists of two parallel sub-studies in subjects undergoing Radical Cystectomy (RC) or Complex Abdominal Wall Reconstruction (CAWR). Within each sub-study, eligible participants will be randomized 1:1 on postoperative Day 1 to receive TU-100 7.5 g/day or matching placebo. Aanalyses will be performed for each sub-study individually and for key outcomes for the pooled sub-studies.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share