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).
Subjects will be screened up to 28 days before their planned surgery and will be randomized 1:1:1 (TU-100 15 g/day: TU-100 7.5 g/day: placebo) on postoperative Day 1 before the first dose of study medication. After randomization, subjects will receive a total daily dose of TU-100 15g, TU-100 7.5 g, 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 adjunct to an enhanced recovery (ERAS) pathway for gastrointestinal (GI) recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
402
Time to Gastrointestinal Recovery (GIR)
Time to achieve recovery of GI motility as measured by a composite endpoint representing upper AND lower GI recovery
Time frame: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Time to GIR Responses
Time to achieve first toleration of solid diet AND first bowel movement (Time to GI-2), time to first toleration of clear liquids, and time to absence of distension and presence of bowel sounds and flatus
Time frame: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Time to Discharge
Time at which the subject is considered ready for discharge by the investigator based solely on GI recovery (Time to ready for discharge), and time at which the investigator writes discharge order for the subject (Time to discharge order written)
Time frame: From surgery to hospital discharge
GIR Outcome Related to Length of Hospitalization (Mean)
Mean number of days that the subject stayed in the hospital calculated based on calendar day of discharge order written
Time frame: From surgery to hospital discharge
GIR Outcome Related to Length of Hospitalization (Median)
Median number of days that the subject stayed in the hospital calculated based on calendar day of discharge order written
Time frame: From surgery to hospital discharge
Percentage of GIR Responders
Percentage of subjects who achieve GIR (GIR responders) by day
Time frame: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
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Florence Site
Florence, Alabama, United States
Gilbert Site
Gilbert, Arizona, United States
Little Rock Site
Little Rock, Arkansas, United States
Duarte Site
Duarte, California, United States
Los Angeles Site #1
Los Angeles, California, United States
Los Angeles Site #2
Los Angeles, California, United States
Palo Alto Site
Palo Alto, California, United States
Sacramento Site
Sacramento, California, United States
Danbury Site
Danbury, Connecticut, United States
Clearwater Site
Clearwater, Florida, United States
...and 26 more locations
POI-related Morbidity
Primary POI that is not secondary to surgical complication, such as anastomotic leak, abscess formation, or sepsis that requires readmission within 7 days of discharge, or need for postoperative nasal gastric tube insertion to manage symptoms of POI (vomiting/retching, abdominal distension)
Time frame: From the day after surgery to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Number of Participants With Adverse Events
Number of patients with adverse events (AEs) observed following administration of TU-100.
Time frame: From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)