A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection (INTEGRITY)
Primary Purpose
Ileus, Gastro-Intestinal Disorder
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
LB1148
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ileus focused on measuring post operative ileus, return of bowel function, return of gastrointestinal function, enterotomy, colon surgery, colorectal surgery, intestinal surgery
Eligibility Criteria
Inclusion Criteria:
Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:
- Adults age 18 to 80 years, inclusive.
- 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.
- 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.
- 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 exclusion criteria:
- History of total colectomy.
- Has a preexisting ostomy.
- History of radiation enteritis.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
- History of seizure disorder.
- History of myeloproliferative disorders.
- American Society of Anesthesiologists (ASA) Class IV or V.
- Inability to take IP orally or consume solid food.
- Planned treatment with alvimopan (Entereg®) during hospitalization period
- Chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.
- Men and women of child bearing potential (WOCBP) who are unwilling to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods (but not combination hormonal methods), intrauterine device, or use of spermicide combined with a barrier method (e.g., condom, diaphragm) for 28 days before Day 1 and through Day 30.
- Women who will not agree to stop combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch or vaginal ring) during the 7 day period prior to Surgery (Study Day 2) through the 7 day period following surgery (Study Days 3 through 9).
Has contraindications or potential risk factors to taking TXA. These include subjects with:
- Known sensitivity to TXA
- Recent craniotomy (past 30 days)
- Active cerebrovascular bleed
- Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome)
- Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction
- Receipt of any investigational drug within 28 days or 5 half-lives prior to Day 1.
- Any other condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements.
Sites / Locations
- Site 315
- Site 354
- Site 329
- Site 350
- Site 312
- Site 359
- Site 351
- Site 358
- Site 331
- Site 357
- Site 321
- Site 324
- Site 355
- Site 325
- Site 352
- Site 317
- Site 356
- Site 318
- Site 313
- Site 353
- Site 320
- Site 319
- Site 326
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LB1148
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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 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 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 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05470387
Brief Title
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
Acronym
INTEGRITY
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of LB1148 in Accelerating the Time to Return of Bowel Function in Subjects Undergoing Planned Bowel Resection (INTEGRITY)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palisade Bio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus, Gastro-Intestinal Disorder
Keywords
post operative ileus, return of bowel function, return of gastrointestinal function, enterotomy, colon surgery, colorectal surgery, intestinal surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LB1148
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
LB1148
Other Intervention Name(s)
Active
Intervention Description
A total of 700 mL of drug product will be administered orally as a split dose before surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A total of 700 mL of placebo will be administered orally as a split dose before surgery.
Primary Outcome Measure Information:
Title
Time to return of gastrointestinal function
Description
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
Secondary Outcome Measure Information:
Title
Time to first bowel movement
Description
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
Title
Time subject is ready for discharge
Description
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
Title
Time discharge order written
Description
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
Title
Time of actual discharge
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:
Adults age 18 to 80 years, inclusive.
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.
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.
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 exclusion criteria:
History of total colectomy.
Has a preexisting ostomy.
History of radiation enteritis.
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
History of seizure disorder.
History of myeloproliferative disorders.
American Society of Anesthesiologists (ASA) Class IV or V.
Inability to take IP orally or consume solid food.
Planned treatment with alvimopan (Entereg®) during hospitalization period
Chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.
Men and women of child bearing potential (WOCBP) who are unwilling to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods (but not combination hormonal methods), intrauterine device, or use of spermicide combined with a barrier method (e.g., condom, diaphragm) for 28 days before Day 1 and through Day 30.
Women who will not agree to stop combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch or vaginal ring) during the 7 day period prior to Surgery (Study Day 2) through the 7 day period following surgery (Study Days 3 through 9).
Has contraindications or potential risk factors to taking TXA. These include subjects with:
Known sensitivity to TXA
Recent craniotomy (past 30 days)
Active cerebrovascular bleed
Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome)
Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction
Receipt of any investigational drug within 28 days or 5 half-lives prior to Day 1.
Any other condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements.
Facility Information:
Facility Name
Site 315
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Site 354
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Site 329
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Site 350
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site 312
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Site 359
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Site 351
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Site 358
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Site 331
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Site 357
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Site 321
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Site 324
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Site 355
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Site 325
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Site 352
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site 317
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Site 356
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Site 318
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Site 313
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Site 353
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Site 320
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Site 319
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site 326
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
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