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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02836470
Other study ID # LBS-POI-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2019
Est. completion date September 8, 2023

Study information

Verified date April 2024
Source Palisade Bio
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 112
Est. completion date September 8, 2023
Est. primary completion date September 6, 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 (EnteregĀ®) during study participation period. 12. Planned use of 4% icodextrin (AdeptĀ®) 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.

Study Design


Related Conditions & MeSH terms


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-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
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