At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 402 enrolled
Drug / intervention
TU-100 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery (ERAS) Protocol in Subjects Undergoing Bowel Resection
In Brief
A Phase 2 clinical trial evaluating TU-100 and Placebo for Enhanced Recovery After Surgery. Completed, enrolled 402 participants across 36 sites.
Detailed Summary
This multicenter, randomized, double-blinded, placebo-controlled study will evaluate the effect of TU-100 on resolution of postoperative ileus (POI) in subjects undergoing open or laparoscopic bowel resection (BR).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnhanced Recovery After Surgery
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedFeb 2021
Enrollment StartJul 2021
Primary CompletionMar 2024
Study CompletionMay 2024
TodayJul 2026
First PostedFeb 8, 2021
Enrollment StartJul 29, 2021
Primary CompletionMar 25, 2024
Study CompletionMay 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.4 years ago
Interventions
TU-100drug
Treatment with investigational product
Placebodrug
Treatment with placebo product