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

NCT02836470 | Completed Phase 2 Results FDA Drug

• 1 other identifier: LBS-POI-201
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 28

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.

Conditions

Ileus; Post-Operative Adhesions

Keywords

Post-operative Ileus; Post-Operative Abdominal Adhesions; Return of Gastrointestinal Function; Anastomosis; Enterotomy; Enterostomy; Colorectal Surgery; Intestines Surgery

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo

  Extent and severity of intra-abd. adhesions will be determined by the surgeon using the "Intra-Abdominal Adhesion Extent and Severity Assessment Worksheet" with a min. value of zero (0) (better) and a max. value of one hundred and eight (108) (worse). And which records four (4) Sub scores for nine (9) abd. regions which are all summed to make the Total Extent and severity score. Sub scores include: 1) Abd. Wall to Bowel Extent Score (0-3); 2) Abd. Wall to Bowl Severity Score (0-3); Bowel to Bowel (or Viscera) Extent Score (0-3); Bowel to Bowel (or Viscera) Severity Score (0-3); The nine (9) Abd. Regions include: Right upper; Epigastrium; Left upper; Left flank; Left lower; Pelvis; Right lower; Right flank; and Central. Each Sub score is scored with a min. value of zero (0) (better) and a max. value of three (3) (worse); 0=no adhesion; 1=min. (\<1/3 of the site is covered); 2=mod. (1/3 to 2/3 of the site is covered); 3=extensive (\>2/3 of the site is covered).

  up to 8 months from the index surgery

Study Arms (2)

LB1148

EXPERIMENTAL

Active

Drug: LB1148

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

LB1148 DRUG

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

Also known as: Active

LB1148

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Planned stoma takedown or other planned abdominal surgery within 8 months of the initial surgery.
• 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.
• 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.

You may not qualify if:

• \<18 or \>80 years of age.
• Requires emergency bowel surgery.
• 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.
• American Society of Anesthesiologists (ASA) Class 4 or 5.
• Known inability to take the study drug orally (i.e. complete small bowel obstruction).
• Has contraindications or potential risk factors to taking TXA. These include subjects with:
• Known sensitivity to TXA;
• Recent craniotomy (past 30 days);
• Active cerebrovascular bleed;
• Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome);
• Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction, or
• Continuing use of a combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch, or vaginal ring).
• Has peritoneal carcinomatosis
• History of or current seizure disorder.

Sponsors & Collaborators

• Palisade Bio: lead

Study Sites (28)

Site 315

Mobile, Alabama, 36617, United States

Location

Site 307

Yuma, Arizona, 85364, United States

Location

Site 329

Irvine, California, 92868, United States

Location

Site 310

Pasadena, California, 91105, United States

Location

Site 302

Sylmar, California, 91342, United States

Location

Site 312

Torrance, California, 90502, United States

Location

Site 306

Clearwater, Florida, 33756, United States

Location

Site 303

Miami, Florida, 33125, United States

Location

Site 331

Miami, Florida, 33126, United States

Location

Site 305

Miami, Florida, 33142, United States

Location

Site 308

Orlando, Florida, 32804, United States

Location

Site 328

Louisville, Kentucky, 40202, United States

Location

Site 321

Baltimore, Maryland, 21237, United States

Location

Site 324

Burlington, Massachusetts, 01850, United States

Location

Site 325

Rochester, Minnesota, 55905, United States

Location

Site 317

New York, New York, 10029, United States

Location

Site 323

New York, New York, 10075, United States

Location

Site 318

Chapel Hill, North Carolina, 27599, United States

Location

Site 301

Cleveland, Ohio, 44195, United States

Location

Site 322

Pittsburgh, Pennsylvania, 15212, United States

Location

Site 330

Wynnewood, Pennsylvania, 19096, United States

Location

Site 327

Charleston, South Carolina, 29425, United States

Location

Site 320

Dallas, Texas, 75390, United States

Location

Site 316

Fort Worth, Texas, 76104, United States

Location

Site 311

Houston, Texas, 77024, United States

Location

Site 319

Houston, Texas, 77030, United States

Location

Sie 309

Houston, Texas, 77089, United States

Location

Site 326

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Ileus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Mitchell Jones, CMO
• Organization: Palisade Bio

mitchell.jones@palisadebio.com

858-704-4900

Study Officials

• Mitch Jones, MD

  CMO

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 19, 2016
• Study Start: October 1, 2019
• Primary Completion: September 6, 2023
• Study Completion: September 8, 2023
• Last Updated: June 21, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)