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

NCT07765589 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-08-14

No results posted yet for this study

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)

Interventions

DRUG

TU-100

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Tsumura USA

    lead INDUSTRY

Principal Investigators

  • Tomoyuki Hashiguchi, Director, Clinical Development · Tsumura USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-06-30
Completion
2028-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07765589 on ClinicalTrials.gov