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

NCT ID: NCT02836470

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2023-09-08

Brief 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.

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.

Conditions

Ileus; Post-Operative Adhesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LB1148

Active

Group Type: EXPERIMENTAL

LB1148

Intervention Type: DRUG

A total of 700 mL of drug product will be administered orally as a split dose before surgery.

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A total of 700 mL of placebo will be administered orally as a split dose before surgery.

Interventions

LB1148

A total of 700 mL of drug product will be administered orally as a split dose before surgery.

Intervention Type: DRUG

Placebo

A total of 700 mL of placebo will be administered orally as a split dose before surgery.

Intervention Type: DRUG

Other Intervention Names

Active

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Palisade Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitch Jones, MD

Role: STUDY_DIRECTOR

CMO

Locations

Site 315

Mobile, Alabama, United States

Site 307

Yuma, Arizona, United States

Site 329

Irvine, California, United States

Site 310

Pasadena, California, United States

Site 302

Sylmar, California, United States

Site 312

Torrance, California, United States

Site 306

Clearwater, Florida, United States

Site 303

Miami, Florida, United States

Site 331

Miami, Florida, United States

Site 305

Miami, Florida, United States

Site 308

Orlando, Florida, United States

Site 328

Louisville, Kentucky, United States

Site 321

Baltimore, Maryland, United States

Site 324

Burlington, Massachusetts, United States

Site 325

Rochester, Minnesota, United States

Site 317

New York, New York, United States

Site 323

New York, New York, United States

Site 318

Chapel Hill, North Carolina, United States

Site 301

Cleveland, Ohio, United States

Site 322

Pittsburgh, Pennsylvania, United States

Site 330

Wynnewood, Pennsylvania, United States

Site 327

Charleston, South Carolina, United States

Site 320

Dallas, Texas, United States

Site 316

Fort Worth, Texas, United States

Site 311

Houston, Texas, United States

Site 319

Houston, Texas, United States

Sie 309

Houston, Texas, United States

Site 326

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

LBS-POI-201

Identifier Type: -

Identifier Source: org_study_id