Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 (EnteregĀ®) 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LB1148
Active
  • Drug: LB1148
    A total of 700 mL of drug product will be administered orally as a split dose before surgery.
    Other names:
    • Active
Placebo Comparator
Placebo
Placebo
  • Drug: Placebo
    A total of 700 mL of placebo will be administered orally as a split dose before surgery.

Recruiting Locations

Memorial Hermann Southeast
Houston, Texas 77089
Contact:
Ori Hampel, MD
713-477-8600

Memorial Hermann Memorial City
Houston, Texas 77024
Contact:
Alan Skolnick, MD
713-480-3028
drskolnick@researchhd.com

More Details

Status
Recruiting
Sponsor
Leading BioSciences, Inc

Study Contact

Thomas M Hallam, PhD
858-704-4900
tom.hallam@leadingbiosciences.com

Detailed Description

This will be a multicenter, randomized, double-blind, parallel, placebo-controlled, proof-of-concept, adaptive design, Phase 2 study to evaluate LB1148 for return of gastrointestinal function and reduction of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel resection surgery with or without a planned stoma.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.