Trial Outcomes & Findings for A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection (NCT NCT05470387)
NCT ID: NCT05470387
Last Updated: 2024-06-13
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
From surgical procedure up to 14 days in hospital
Results posted on
2024-06-13
Participant Flow
Participant milestones
| Measure |
LB1148
LB1148: A total of 700 mL of drug product was administered orally as a split dose before surgery.
|
Placebo
Placebo: A total of 700 mL of placebo was administered orally as a split dose before surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
|
Overall Study
COMPLETED
|
13
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
LB1148
LB1148: A total of 700 mL of drug product was administered orally as a split dose before surgery.
|
Placebo
Placebo: A total of 700 mL of placebo was administered orally as a split dose before surgery.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
3
|
Baseline Characteristics
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
Baseline characteristics by cohort
| Measure |
LB1148
n=13 Participants
LB1148: A total of 700 mL of drug product was administered orally as a split dose before surgery.
|
Placebo
n=10 Participants
Placebo: A total of 700 mL of placebo was administered orally as a split dose before surgery.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 12.59 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 17.47 • n=7 Participants
|
49.0 years
STANDARD_DEVIATION 15.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From surgical procedure up to 14 days in hospitalPopulation: This study was terminated early with less than 5% of the study population enrolled. As a result, formal efficacy analyses were not performed.
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
Outcome measures
| Measure |
LB1148
n=13 Participants
LB1148: A total of 700 mL of drug product will be administered orally as a split dose before surgery.
|
Placebo
n=7 Participants
Placebo: A total of 700 mL of placebo will be administered orally as a split dose before surgery.
|
|---|---|---|
|
Time to Return of Gastrointestinal Function
|
81.7 hours
Standard Deviation 44.67
|
90.57 hours
Standard Deviation 76.25
|
SECONDARY outcome
Timeframe: From surgical procedure up to 14 days in hospitalPopulation: This study was terminated early with less than 5% of the study population enrolled. As a result, formal efficacy analyses were not performed.
Time in hours from placement of the last skin staple or suture to the time of first bowel movement
Outcome measures
| Measure |
LB1148
n=13 Participants
LB1148: A total of 700 mL of drug product will be administered orally as a split dose before surgery.
|
Placebo
n=7 Participants
Placebo: A total of 700 mL of placebo will be administered orally as a split dose before surgery.
|
|---|---|---|
|
Time to First Bowel Movement
|
51.54 hours
Standard Deviation 31.08
|
46.67 hours
Standard Deviation 24.66
|
SECONDARY outcome
Timeframe: From surgical procedure up to 14 days in hospitalPopulation: This study was terminated early with less than 5% of the study population enrolled. As a result, formal efficacy analyses were not performed.
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
Outcome measures
| Measure |
LB1148
n=13 Participants
LB1148: A total of 700 mL of drug product will be administered orally as a split dose before surgery.
|
Placebo
n=7 Participants
Placebo: A total of 700 mL of placebo will be administered orally as a split dose before surgery.
|
|---|---|---|
|
Time Subject is Ready for Discharge
|
154.48 hours
Standard Deviation 102.09
|
113.11 hours
Standard Deviation 74.75
|
SECONDARY outcome
Timeframe: From surgical procedure up to 14 days in hospitalPopulation: This study was terminated early with less than 5% of the study population enrolled. As a result, formal efficacy analyses were not performed.
Time discharge order written, defined as the time from the end of surgery to the time that the hospital discharge order is written
Outcome measures
| Measure |
LB1148
n=13 Participants
LB1148: A total of 700 mL of drug product will be administered orally as a split dose before surgery.
|
Placebo
n=7 Participants
Placebo: A total of 700 mL of placebo will be administered orally as a split dose before surgery.
|
|---|---|---|
|
Time Discharge Order Written
|
155.62 hours
Standard Deviation 100.63
|
113.11 hours
Standard Deviation 74.75
|
SECONDARY outcome
Timeframe: From surgical procedure up to 14 days in hospitalPopulation: This study was terminated early with less than 5% of the study population enrolled. As a result, formal efficacy analyses were not performed.
Time of actual discharge, defined as the time from the end of surgery to the time the subject is actually discharged from the hospital
Outcome measures
| Measure |
LB1148
n=13 Participants
LB1148: A total of 700 mL of drug product will be administered orally as a split dose before surgery.
|
Placebo
n=7 Participants
Placebo: A total of 700 mL of placebo will be administered orally as a split dose before surgery.
|
|---|---|---|
|
Time of Actual Discharge
|
159.01 hours
Standard Deviation 100.33
|
116.81 hours
Standard Deviation 75.30
|
Adverse Events
LB1148
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LB1148
n=13 participants at risk
LB1148: A total of 700 mL of drug product will be administered orally as a split dose before surgery.
|
Placebo
n=10 participants at risk
Placebo: A total of 700 mL of placebo will be administered orally as a split dose before surgery.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Abdominal Abscess
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Injury, poisoning and procedural complications
Anastomatic leak
|
0.00%
0/13 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma necrosis
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Injury, poisoning and procedural complications
Pelvic Abscess
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
23.1%
3/13 • Number of events 3 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Injury, poisoning and procedural complications
Sepsis
|
0.00%
0/13 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Acidosis
|
0.00%
0/13 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
Other adverse events
| Measure |
LB1148
n=13 participants at risk
LB1148: A total of 700 mL of drug product will be administered orally as a split dose before surgery.
|
Placebo
n=10 participants at risk
Placebo: A total of 700 mL of placebo will be administered orally as a split dose before surgery.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.4%
2/13 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
20.0%
2/10 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Cardiac disorders
Bradycardia
|
15.4%
2/13 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
40.0%
4/10 • Number of events 4 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Cardiac disorders
Tachycardia
|
30.8%
4/13 • Number of events 4 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
20.0%
2/10 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Eye disorders
Visual Impairment
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
General disorders
Pyrexia
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/13 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Infections and infestations
Sepsis
|
0.00%
0/13 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.00%
0/13 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
15.4%
2/13 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
15.4%
2/13 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
20.0%
2/10 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
38.5%
5/13 • Number of events 5 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
40.0%
4/10 • Number of events 4 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.4%
2/13 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hyperphospataemia
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
15.4%
2/13 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
15.4%
2/13 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Anthralgia
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Nervous system disorders
Hypoaesthesia
|
15.4%
2/13 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Nervous system disorders
Somnolence
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/13 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/13 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
15.4%
2/13 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
20.0%
2/10 • Number of events 2 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
0.00%
0/10 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
|
Vascular disorders
Pelvic haematoma
|
0.00%
0/13 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
10.0%
1/10 • Number of events 1 • All AEs were collected for all subjects during their participation from Study Day 1 through Hospital Discharge or Day 16, whichever is earlier.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place