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

Palisade Bio

Status and phase: Completed; Phase 2

Conditions: Ileus; Post-Operative Adhesions

Treatments: Drug: Placebo; Drug: LB1148

Study type: Interventional

Funder types: Industry

Identifiers

NCT02836470

LBS-POI-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 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. Planned stoma takedown or other planned abdominal surgery within 8 months of the initial surgery.
3. Willing to perform and comply with all study procedures including attending clinic visit as scheduled and completion of a second surgery for stoma takedown or other abdominal surgery and to determine the presence of intra-abdominal adhesions.
4. 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. Known inability to take the study drug orally (i.e. complete small bowel obstruction).

6. 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).

7. Has peritoneal carcinomatosis

8. History of or current seizure disorder.

9. Patients with myeloproliferative disorders.

10. 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.

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

12. Planned use of 4% icodextrin (Adept®) or SEPRAFILM during the first surgery.

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

14. 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.

15. Known history of radiation enteritis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 2 patient groups, including a placebo group

LB1148

Experimental group

Description:

Active

Treatment:

Drug: LB1148

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo