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)

The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.

Study Overview

• Status: Active, not recruiting
• Conditions: Ileus; Gastro-Intestinal Disorder
• Intervention / Treatment: Drug: Placebo; Drug: LB1148

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36617
      • Site 315
  • California
    • La Jolla, California, United States, 92037
      • Site 354
    • Orange, California, United States, 92868
      • Site 329
    • San Diego, California, United States, 92123
      • Site 350
    • Torrance, California, United States, 90502
      • Site 312
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Site 359
  • Florida
    • Clearwater, Florida, United States, 33756
      • Site 351
    • Jacksonville, Florida, United States, 32224
      • Site 358
    • Miami, Florida, United States, 33136
      • Site 331
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Site 357
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Site 321
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Site 324
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Site 355
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Site 325
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Site 352
  • New York
    • New York, New York, United States, 10029
      • Site 317
    • New York, New York, United States, 10032
      • Site 356
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Site 318
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Site 313
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Site 353
  • Texas
    • Dallas, Texas, United States, 75390
      • Site 320
    • Houston, Texas, United States, 77030
      • Site 319
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Site 326

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 exclusion criteria:

1. History of total colectomy.
2. Has a preexisting ostomy.
3. History of radiation enteritis.
4. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
5. History of seizure disorder.
6. History of myeloproliferative disorders.
7. American Society of Anesthesiologists (ASA) Class IV or V.
8. Inability to take IP orally or consume solid food.
9. Planned treatment with alvimopan (Entereg®) during hospitalization period
10. Chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.
11. 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.
12. 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).

13. 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
14. Receipt of any investigational drug within 28 days or 5 half-lives prior to Day 1.
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; A total of 700 mL of placebo will be administered orally as a split dose before surgery.
Experimental: LB1148	Drug: LB1148; A total of 700 mL of drug product will be administered orally as a split dose before surgery.; Other Names: Active

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first bowel movement	Time in hours from placement of the last skin staple or suture to the time of first bowel movement	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	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	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	From surgical procedure up to 14 days in hospital

Collaborators and Investigators

• Sponsor: Palisade Bio

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: colorectal surgery; colon surgery; post operative ileus; return of bowel function; return of gastrointestinal function; enterotomy; intestinal surgery
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases
• Other Study ID Numbers: PBI-POI-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No