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TU-100 for Enhanced Postoperative Recovery

Phase 2
Recruiting
Research Sponsored by Tsumura USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to understand the study procedures, have agreed to participate in the study program, and have voluntarily provided informed consent
Male or female ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the day after surgery to discharge follow-up visit (30 days (+ 7 days) after hospital discharge)
Awards & highlights

Study Summary

This trial will test if TU-100 can help POI after surgery. TU-100 will be compared to a placebo in those who had open or laparoscopic bowel resection.

Who is the study for?
Adults over 18, able to consent and follow study procedures, undergoing elective bowel resection surgery. They must use effective contraception if of childbearing potential. Excluded are those with recent heart attacks, certain surgeries or conditions that could affect results or pose risks, uncontrolled illnesses like severe heart failure or arrhythmias, compromised immune systems, pregnant or lactating women, and anyone using certain supplements.Check my eligibility
What is being tested?
The trial is testing TU-100's effectiveness in speeding up recovery from postoperative ileus (delayed bowel function) after bowel resection surgery compared to a placebo. Participants will be randomly assigned to either the TU-100 group or the placebo group without knowing which one they receive.See study design
What are the potential side effects?
Specific side effects aren't listed for TU-100; however, participants should report any unusual symptoms as they may relate to the intervention. Common surgical recovery issues may include pain at the incision site, nausea, constipation or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the study and have agreed to participate willingly.
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I am 18 years old or older.
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I am willing to use effective birth control during and 30 days after the study.
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My health is good to moderately impaired.
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I am scheduled for a bowel resection surgery, either open or with a camera.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the day after surgery to discharge follow-up visit (30 days (+ 7 days) after hospital discharge)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the day after surgery to discharge follow-up visit (30 days (+ 7 days) after hospital discharge) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to gastrointestinal recovery (GIR)
Secondary outcome measures
GIR outcome related to length of hospitalization
POI-related morbidity
Safety of TU-100
+1 more
Other outcome measures
Effects of TU-100 on early postoperative surgical outcomes related to mechanism of action

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: TU-100 7.5 g/dayExperimental Treatment1 Intervention
Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
Group II: TU-100 15 g/dayExperimental Treatment1 Intervention
Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
Group III: PlaceboPlacebo Group1 Intervention
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TU-100
2014
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Tsumura USALead Sponsor
9 Previous Clinical Trials
528 Total Patients Enrolled

Media Library

TU-100 Clinical Trial Eligibility Overview. Trial Name: NCT04742907 — Phase 2
Enhanced Recovery After Surgery Research Study Groups: TU-100 15 g/day, TU-100 7.5 g/day, Placebo
Enhanced Recovery After Surgery Clinical Trial 2023: TU-100 Highlights & Side Effects. Trial Name: NCT04742907 — Phase 2
TU-100 2023 Treatment Timeline for Medical Study. Trial Name: NCT04742907 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is TU-100 a new experimental drug?

"As of now, there is only one trial studying the effects of TU-100. However, this research is still in operation and has not yet entered into Phase 3 testing. Additionally, even though most of the clinical trials for TU-100 are based out of Little Rock, Arkansas, there are a total 44 locations running these studies."

Answered by AI

Could you please tell me the mortality rate of TU-100?

"TU-100's safety was given a score of 2 by our analysts because, while Phase 2 trials provide some evidence of safety, there is no data currently available to support efficacy."

Answered by AI

What are the precedents for this type of research?

"TU-100 is only being studied in one active clinical trial across 37 locations in a single country. The first study of TU-100 was completed in 2021 and it reached Phase 2 approval. A total of 402 patients were involved in the study, which was sponsored by Tsumura USA. Since then, 18291 studies have been completed."

Answered by AI

How many research facilities are conducting this trial?

"Presently, this study is recruiting patients from 42 different sites. Some of these locations are in Weston, Salt Lake City and Danbury with the other 39 cities being located elsewhere. If you are considering participating in this trial, it may be convenient to select a location nearest to you to limit travel requirements."

Answered by AI

How many people will be enrolled in this clinical trial?

"The clinical trial is still open and actively recruiting patients, as of 11/10/2022. According to the information available on ClinicalTrials.gov, this study was first posted on 7/29/2021. They are looking for a total of 402 participants across 42 sites."

Answered by AI

Are there any vacancies in this trial for new participants?

"Yes, the trial is still recruiting patients. The relevant information on clinicaltrials.gov indicates that the study was posted on 29 July 2021 and last updated 10 November 20202."

Answered by AI
~110 spots leftby Mar 2025