A Tolerability and Efficacy Study of TU-100 For The Treatment of Postoperative Ileus
A Randomized, Controlled, Open-Label Tolerability And Efficacy Study Of TU-100 For The Treatment Of Postoperative Ileus In Patients Undergoing Laparotomy For Large Bowel Resection
Sponsor: Tsumura USA
A PHASE2 clinical study on Postoperative Ileus, this trial is completed. The trial is conducted by Tsumura USA and has accumulated 9 data snapshots since 2005. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)This is a randomized, controlled, open-label study designed to evaluate the tolerability and efficacy of TU-100 for the treatment of POI in patients undergoing laparotomy for large bowel resection. It will be conducted at multiple centers in the United States. A total of 24 patients will be enrolled in the study. Patient participation in the study will last for up to 32 days (from Screening to postoperative day 10 \[POD 10\] or until the time when a discharge order is written for the patient, whichever comes first), with follow-up safety assessments to occur 7 and 14 days after the last dose of study medication.
This is a randomized, controlled, open-label study designed to evaluate the tolerability and efficacy of TU-100 for the treatment of POI in patients undergoing laparotomy for large bowel resection. It will be conducted at multiple centers in the United States. A total of 24 patients will be enrolled in the study. Patient participation in the study will last for up to 32 days (from Screening to postoperative day 10 \[POD 10\] or until the time when a discharge order is written for the patient, whichever comes first), with follow-up safety assessments to occur 7 and 14 days after the last dose of study medication.
Status Flow
Change History
9 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2025 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Apr 2022 — Jul 2024 [monthly]
Completed PHASE2
▶ Show 4 earlier versions
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Jan 2021 — Apr 2022 [monthly]
Completed PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Dec 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Tsumura USA
For direct contact, visit the study record on ClinicalTrials.gov .