The objective of this study is to compare the efficacy of naldemedine versus placebo and to assess its effect on the time to gastrointestinal (GI) recovery following surgeries that include bowel resection and bowel transection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
Oral tablet
Oral tablet
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Norton Hospital
Louisville, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
University of Louisville Division of Surgery
Louisville, Kentucky, United States
Time From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2)
Time frame: Up to 10 days After Surgery
Time From the End of Surgery to Time When the Discharge Order is Written
Time frame: Up to 10 days After Surgery
Percentage of Participants Requiring Postoperative Reinsertion of the Nasogastric Tube
Time frame: Up to 10 days After Surgery
Percentage of Participants With Nausea on Days 1 Through 3
Time frame: Days 1 to 3 After Surgery
Percentage of Participants With Vomiting on Days 1 Through 3
Time frame: Days 1 to 3 After Surgery
Percentage of Participants Discharged by Day 10 Who Are Readmitted for Any Reason Within 30 Days After Discharge From the Hospital
Time frame: From the Discharge Date (Days 1-10) up to 30 Days After Discharge
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Houston Methodist Hospital
Houston, Texas, United States
CHRISTUS Mother Frances Hospital - Tyler
Tyler, Texas, United States
CHRISTUS Trinity Clinic Research
Tyler, Texas, United States
CHRISTUS Trinity Clinic Surgical Oncology
Tyler, Texas, United States