The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
This will be a multicenter, randomized, double-blind, placebo-controlled, study to evaluate the safety and efficacy of LB1148 in return to bowel function for subjects undergoing planned bowel resection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
Site 315
Mobile, Alabama, United States
Site 354
La Jolla, California, United States
Time to Return of Gastrointestinal Function
The later of the times in hours from placement of the last skin staple or suture to the time of toleration of solid food (defined as the time a subject finished a meal that required chewing and experienced no significant nausea/vomiting for 4 hours after the solid meal) and the first bowel movement, up to 14 days post-surgery
Time frame: From surgical procedure up to 14 days in hospital
Time to First Bowel Movement
Time in hours from placement of the last skin staple or suture to the time of first bowel movement
Time frame: From surgical procedure up to 14 days in hospital
Time Subject is Ready for Discharge
Time subject is ready for discharge, defined as the time from the end of surgery to the time the subject is ready for hospital discharge solely based on the recovery of GI function, as determined by the surgeon
Time frame: From surgical procedure up to 14 days in hospital
Time Discharge Order Written
Time discharge order written, defined as the time from the end of surgery to the time that the hospital discharge order is written
Time frame: From surgical procedure up to 14 days in hospital
Time of Actual Discharge
Time of actual discharge, defined as the time from the end of surgery to the time the subject is actually discharged from the hospital
Time frame: From surgical procedure up to 14 days in hospital
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site 329
Orange, California, United States
Site 350
San Diego, California, United States
Site 312
Torrance, California, United States
Site 359
Bridgeport, Connecticut, United States
Site 351
Clearwater, Florida, United States
Site 358
Jacksonville, Florida, United States
Site 331
Miami, Florida, United States
Site 357
Iowa City, Iowa, United States
...and 13 more locations