A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection

Phase 3

Terminated

• Conditions: Gastro-Intestinal Disorder; Ileus
• Interventions: Drug: LB1148; Drug: Placebo

• Registration Number: NCT05470387
• Lead Sponsor: Palisade Bio

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.

Study Timeline

• Study Start: 2022-06-28
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Primary Completion: 2023-03-06
• Study Completion: 2023-08-11
• Status Verified: 2024-04
• Results First Submitted: 2024-04-01
• Results First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Results First Posted: 2024-06-13
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LB1148	LB1148	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (23)

Site 331; 🇺🇸 Miami, Florida, United States

Site 312; 🇺🇸 Torrance, California, United States

Site 351; 🇺🇸 Clearwater, Florida, United States

Site 357; 🇺🇸 Iowa City, Iowa, United States

Site 321; 🇺🇸 Baltimore, Maryland, United States

Site 315; 🇺🇸 Mobile, Alabama, United States

Site 354; 🇺🇸 La Jolla, California, United States

Site 350; 🇺🇸 San Diego, California, United States

Site 329; 🇺🇸 Orange, California, United States

Site 358; 🇺🇸 Jacksonville, Florida, United States

Site 355; 🇺🇸 Grand Rapids, Michigan, United States

Site 317; 🇺🇸 New York, New York, United States

Site 352; 🇺🇸 Saint Louis, Missouri, United States

Site 356; 🇺🇸 New York, New York, United States

Site 313; 🇺🇸 Columbus, Ohio, United States

Site 353; 🇺🇸 Providence, Rhode Island, United States

Site 320; 🇺🇸 Dallas, Texas, United States

Site 319; 🇺🇸 Houston, Texas, United States

Site 326; 🇺🇸 Salt Lake City, Utah, United States

Site 359; 🇺🇸 Bridgeport, Connecticut, United States

Site 325; 🇺🇸 Rochester, Minnesota, United States

Site 324; 🇺🇸 Burlington, Massachusetts, United States

Site 318; 🇺🇸 Chapel Hill, North Carolina, United States