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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel resection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leading BioSciences, Inc

Criteria

Inclusion Criteria:

Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:

1. Scheduled to undergo an elective (non-emergent) bowel resection with or without a planned stoma via laparotomy or minimally invasive technique. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elected indication.

2. Has been informed of the nature of the study (either the subject or their legal representative), agrees to its provisions, and has provided 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. <18 or >80 years of age.

2. Requires emergency bowel surgery.

3. Has had 1 or more abdominal surgeries, excluding the current, for inflammatory bowel disease, including, but not limited to, inflammatory bowel disease (IBD), Crohn's Disease, or ulcerative colitis.

Note: This does not apply to previous surgery such as hernia repair unrelated to IBD.

4. American Society of Anesthesiologists (ASA) Class 4 or 5.

5. Insulin dependent diabetes mellitus.

6. Known inability to take the study drug orally (i.e. complete small bowel obstruction).

7. Has contraindications or potential risk factors to taking TXA. These include subjects with:

1. Known sensitivity to TXA;

2. Recent craniotomy (past 30 days);

3. Active cerebrovascular bleed;

4. Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome);

5. Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction, or

6. Continuing use of a combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch, or vaginal ring).

8. Has the following risk factors for thromboembolic disease:

1. Known medical history of congenital or acquired thrombophilia such as, but not limited to patients with:

• Sickle cell disease;

• Nephrotic syndrome;

• Factor V Leiden;

• Prothrombin gene mutation;

• Protein C or S deficiency;

• Antithrombin III deficiency;

• Antiphospholipid syndrome.

2. Stage IV malignant neoplasm;

3. Neurologic paresis, partial paralysis, or paralysis;

4. Pacemaker;

5. History of pulmonary embolism, deep vein thrombosis, cerebrovascular accident, or rental venous/arterial occlusion;

9. History of or current seizure disorder.

10. Patients with myeloproliferative disorders.

11. Body Mass Index (BMI) >40.

12. Any other condition that, in the opinion of the Investigator, would preclude the subject from being an appropriate candidate for the study, including severe renal or hepatic impairment.

13. Planned treatment with alvimopan (Entereg®) during study participation period.

14. Received any other investigational therapy within 4 weeks prior to Randomization

15. Chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.

16. Female subjects of childbearing potential with a positive urine or serum pregnancy test or who are not taking (or not willing to take) acceptable birth control measures (abstinence, intrauterine devices, contraceptive implants or barrier methods) through Day 30. Additionally, those women who are lactating and insist on breast feeding within 5 days of the last dose of study drug.

17. Known history of radiation enteritis.