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

Ileus Clinical Trial

— PROFILE  

Official title:

A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate LB1148 for Return of Gastrointestinal Function, Post-Operative Ileus and Intra-Abdominal Adhesions in Subjects Undergoing Elective Bowel Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02836470
• Other study ID #: LBS-POI-201
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2019
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Palisade Bio
• Contact: Nick McCoy
• Phone: 214-457-1996
• Email: nick.mccoy[@]palisadebio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ileus
• Post-Operative Adhesions
• Tissue Adhesions

Intervention

Drug:
• LB1148
A total of 700 mL of drug product will be administered orally as a split dose before surgery.
• Placebo
A total of 700 mL of placebo will be administered orally as a split dose before surgery.

Locations

Country	Name	City	State
United States	Site 321	Baltimore	Maryland
United States	Site 324	Burlington	Massachusetts
United States	Site 318	Chapel Hill	North Carolina
United States	Site 327	Charleston	South Carolina
United States	Site 306	Clearwater	Florida
United States	Site 301	Cleveland	Ohio
United States	Site 320	Dallas	Texas
United States	Site 316	Fort Worth	Texas
United States	Sie 309	Houston	Texas
United States	Site 311	Houston	Texas
United States	Site 319	Houston	Texas
United States	Site 329	Irvine	California
United States	Site 328	Louisville	Kentucky
United States	Site 303	Miami	Florida
United States	Site 305	Miami	Florida
United States	Site 331	Miami	Florida
United States	Site 315	Mobile	Alabama
United States	Site 317	New York	New York
United States	Site 323	New York	New York
United States	Site 308	Orlando	Florida
United States	Site 310	Pasadena	California
United States	Site 322	Pittsburgh	Pennsylvania
United States	Site 325	Rochester	Minnesota
United States	Site 326	Salt Lake City	Utah
United States	Site 302	Sylmar	California
United States	Site 312	Torrance	California
United States	Site 330	Wynnewood	Pennsylvania
United States	Site 307	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Palisade Bio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in extent and severity of intra-abdominal adhesions among subjects treated with LB1148 or placebo	Extent and severity of intra-abdominal adhesions will be determined by the surgeon using the Intra-Abdominal Adhesion Extent and Severity Assessment Worksheet	up to 8 months from the index surgery
Secondary	Time from surgical closure to resolution or appearance, as appropriate, of 1 or more of the components common to GI dysfunction following elective bowel resection with or without a planned stoma	Compare time from surgical closure to resolution or appearance, as appropriate, of 1 or more of the components common to gastrointestinal (GI) dysfunction following elective bowel resection with a planned stoma.	From surgical closure up to 14 days in hospital
Secondary	Time to return of gastrointestinal function as defined by achieving GI2	GI2 is a composite endpoint defined as the time from the end of surgery to the time of recovery of the upper GI tract (toleration of solid food) and the time to recovery of the lower GI tract (first bowel movement).	From surgical closure up to 14 days in hospital
Secondary	Time to Achieve GI-3	GI3 is defined as the toleration of solid food and either first flatus or bowel movement	From surgical closure up to 14 days in hospital
Secondary	Time to resolution of post-operative ileus	Compare number of hours to resolution of POI.	From surgical closure up to 14 days in hospital
Secondary	Hospital length of stay	Compare hospital length of stay (LOS, recorded in hours) through Discharge or Day 14 (whichever comes first).	From surgical closure up to 14 days in hospital
Secondary	Incidence of intra-abdominal adhesions	Compare the incidence of intra-abdominal adhesions following the second surgery among subjects treated with LB1148 or placebo.	up to 8 months from the index surgery