A Phase 2 interventional study of TU-100 and Placebo in Delay in GI Recovery/Postoperative Ileus (POI), sponsored by Tsumura USA. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Tsumura USA · Phase 2, Interventional, and Treatment
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.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's planned enrollment of 240 is above the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →Tsumura USA is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Subjects will receive placebo TID until hospital discharge or ≤ 10 days after surgery (whichever is earlier).
Drug: Placebo
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.
Matching placebo granules similar in appearance to TU-100 and administered orally three times daily.
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
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.
Time frame: Postoperative Days 1-10
Length of Hospital Stay
Length of hospital stay measured as the number of calendar days from the day of surgery to the date of hospital discharge.
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Occurrence of Nausea, Vomiting and/or Retching, and Abdominal Bloating
Proportion of subjects reporting nausea, vomiting and/or retching, and abdominal bloating during postoperative recovery. Data will be collected using subject-reported assessments and summarized by postoperative day.
Time frame: Postoperative Days 1-10
Bothersomeness of Nausea and Abdominal Bloating
Subject-reported bothersomeness of nausea and abdominal bloating (24-hour reflection) during postoperative recovery. Data will be collected using subject-reported assessments and summarized by postoperative day. Bothersomeness is measured on a 0-10 point scale with 10 being the most bothersome.
Time frame: Postoperative Days 1-10
Average of Abdominal Pain
Subject-reported abdominal pain (24-hour reflection) during postoperative recovery. Data will be collected using subject-reported assessments and summarized by postoperative day. Average abdominal pain will be reported on a 11-point Numeric Pain Rating Scale (NPRS), with 0 being no pain and 10 being worst pain imaginable.
Time frame: Postoperative Days 1-10
Time to ready for discharge
Time from the end of surgery to readiness for discharge, based solely on GI recovery.
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to discharge order written
Time from the end of surgery to discharge order entry.
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to actual hospital discharge
Time from the end of surgery to actual hospital discharge.
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to first consistent flatus
Time from the end of surgery to first consistent flatus.
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to First Spontaneous Bowel Movement
Time from the end of surgery to the first spontaneous bowel movement.
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to Toleration of Solid Food
Time from the end of surgery to the first toleration of solid food without clinically significant intolerance requiring cessation of oral intake.
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tu-100
Tsumura USA