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
Overview
- Phase
- Phase 2
- Intervention
- LB1148
- Conditions
- Ileus
- Sponsor
- Palisade Bio
- Enrollment
- 112
- Locations
- 28
- Primary Endpoint
- Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:
- •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.
Exclusion Criteria
- •Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:
- •\<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
- •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);
Arms & Interventions
LB1148
Active
Intervention: LB1148
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo
Time Frame: up to 8 months from the index surgery
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).