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A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
INTEGRITY
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)
1 other identifier
interventional
23
1 country
23
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2022
Shorter than P25 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2022
CompletedFirst Submitted
Initial submission to the registry
July 20, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2023
CompletedResults Posted
Study results publicly available
June 13, 2024
CompletedJune 13, 2024
April 1, 2024
8 months
July 20, 2022
April 1, 2024
May 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
From surgical procedure up to 14 days in hospital
Secondary Outcomes (4)
Time to First Bowel Movement
From surgical procedure up to 14 days in hospital
Time Subject is Ready for Discharge
From surgical procedure up to 14 days in hospital
Time Discharge Order Written
From surgical procedure up to 14 days in hospital
Time of Actual Discharge
From surgical procedure up to 14 days in hospital
Study Arms (2)
LB1148
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Palisade Biolead
Study Sites (23)
Site 315
Mobile, Alabama, 36617, United States
Site 354
La Jolla, California, 92037, United States
Site 329
Orange, California, 92868, United States
Site 350
San Diego, California, 92123, United States
Site 312
Torrance, California, 90502, United States
Site 359
Bridgeport, Connecticut, 06610, United States
Site 351
Clearwater, Florida, 33756, United States
Site 358
Jacksonville, Florida, 32224, United States
Site 331
Miami, Florida, 33136, United States
Site 357
Iowa City, Iowa, 52242, United States
Site 321
Baltimore, Maryland, 21237, United States
Site 324
Burlington, Massachusetts, 01805, United States
Site 355
Grand Rapids, Michigan, 49503, United States
Site 325
Rochester, Minnesota, 55905, United States
Site 352
St Louis, Missouri, 63110, United States
Site 317
New York, New York, 10029, United States
Site 356
New York, New York, 10032, United States
Site 318
Chapel Hill, North Carolina, 27599, United States
Site 313
Columbus, Ohio, 43210, United States
Site 353
Providence, Rhode Island, 02906, United States
Site 320
Dallas, Texas, 75390, United States
Site 319
Houston, Texas, 77030, United States
Site 326
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mitchell Jones, CMO
- Organization
- Palisade Bio
Study Officials
- STUDY DIRECTOR
Mitch Jones, MD
CMO
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2022
First Posted
July 22, 2022
Study Start
June 28, 2022
Primary Completion
March 6, 2023
Study Completion
August 11, 2023
Last Updated
June 13, 2024
Results First Posted
June 13, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share