Gastro-Intestinal Disorder, Ileus
Conditions
Keywords
post operative ileus, return of bowel function, return of gastrointestinal function, enterotomy, colon surgery, colorectal surgery, intestinal surgery
Brief summary
The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
Detailed description
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.
Interventions
DRUGLB1148
A total of 700 mL of drug product will be administered orally as a split dose before surgery.
DRUGPlacebo
A total of 700 mL of placebo will be administered orally as a split dose before surgery.
Sponsors
Palisade Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria: 1. Adults age 18 to 80 years, inclusive. 2. Scheduled to undergo a planned (non-emergent) bowel resection via minimally invasive technique or laparotomy. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elective indication. 3. Willing to perform and comply with all study procedures including, being hospitalized until achieving GI-2 and responding to telephone follow-up visits as scheduled. 4. Willing and able to provide written informed consent.
Exclusion criteria
Subjects will not be eligible for participation in the study if they meet ANY of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Return of Gastrointestinal Function | From surgical procedure up to 14 days in hospital | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Discharge Order Written | From surgical procedure up to 14 days in hospital | Time discharge order written, defined as the time from the end of surgery to the time that the hospital discharge order is written |
| Time to First Bowel Movement | From surgical procedure up to 14 days in hospital | Time in hours from placement of the last skin staple or suture to the time of first bowel movement |
| Time Subject is Ready for Discharge | From surgical procedure up to 14 days in hospital | 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 of Actual Discharge | From surgical procedure up to 14 days in hospital | Time of actual discharge, defined as the time from the end of surgery to the time the subject is actually discharged from the hospital |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LB1148 LB1148: A total of 700 mL of drug product was administered orally as a split dose before surgery. | 13 |
| Placebo Placebo: A total of 700 mL of placebo was administered orally as a split dose before surgery. | 10 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 3 |
Baseline characteristics
| Characteristic | Placebo | Total | LB1148 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 19 Participants | 12 Participants |
| Age, Continuous | 54.0 years STANDARD_DEVIATION 17.47 | 49.0 years STANDARD_DEVIATION 15.21 | 45.2 years STANDARD_DEVIATION 12.59 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 20 Participants | 10 Participants |
| Region of Enrollment United States | 10 participants | 23 participants | 13 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 14 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 10 |
| other Total, other adverse events | 13 / 13 | 7 / 10 |
| serious Total, serious adverse events | 7 / 13 | 4 / 10 |
Outcome results
Primary
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
Population: This study was terminated early with less than 5% of the study population enrolled. As a result, formal efficacy analyses were not performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LB1148 | Time to Return of Gastrointestinal Function | 81.7 hours | Standard Deviation 44.67 |
| Placebo | Time to Return of Gastrointestinal Function | 90.57 hours | Standard Deviation 76.25 |
Secondary
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
Population: This study was terminated early with less than 5% of the study population enrolled. As a result, formal efficacy analyses were not performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LB1148 | Time Discharge Order Written | 155.62 hours | Standard Deviation 100.63 |
| Placebo | Time Discharge Order Written | 113.11 hours | Standard Deviation 74.75 |
Secondary
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
Population: This study was terminated early with less than 5% of the study population enrolled. As a result, formal efficacy analyses were not performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LB1148 | Time of Actual Discharge | 159.01 hours | Standard Deviation 100.33 |
| Placebo | Time of Actual Discharge | 116.81 hours | Standard Deviation 75.3 |
Secondary
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
Population: This study was terminated early with less than 5% of the study population enrolled. As a result, formal efficacy analyses were not performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LB1148 | Time Subject is Ready for Discharge | 154.48 hours | Standard Deviation 102.09 |
| Placebo | Time Subject is Ready for Discharge | 113.11 hours | Standard Deviation 74.75 |
Secondary
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
Population: This study was terminated early with less than 5% of the study population enrolled. As a result, formal efficacy analyses were not performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LB1148 | Time to First Bowel Movement | 51.54 hours | Standard Deviation 31.08 |
| Placebo | Time to First Bowel Movement | 46.67 hours | Standard Deviation 24.66 |