Adults 18 to 80, any sex, with Ileus or Post-Operative Adhesions. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or PlaceboPrimary· 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) Ab
Minimally Invasive Approach
Group
Value
95% CI
LB1148
20.3
± 23.77
Placebo
4.3
± 5.87
Laparotomy Approach
Group
Value
95% CI
LB1148
4.0
± NA
Placebo
8.5
± 9.19
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT05470387 — A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
· Phase 3
· terminated
NCT04390217 — LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia
· Phase 2
· withdrawn
NCT05056935 — Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus
· Phase 2
· completed
Other recruiting trials for Ileus
Currently open trials in the same condition.
NCT07432542 — Pelvic Floor Peritoneal Closure to Prevent Postoperative Ileus in Mid-Low Rectal Cancer Surgery
· NA
· active not recruiting
NCT06815822 — Prevention of Postoperative Hernias in Emergency Surgery
· recruiting
Other Palisade Bio trials
Trials by the same sponsor.
NCT07428096 — A Study of PALI-2108 in Healthy Volunteers, Patients With Ulcerative Colitis, and Patients With Fibrostenosing Crohn's D
· Phase 1
· active not recruiting
NCT06663605 — Phase 1 Study Evaluating PALI-2108 in Healthy Volunteers and Ulcerative Colitis Patients.
· Phase 1
· completed
NCT05470387 — A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
· Phase 3
· terminated
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Palisade Bio
Last refreshed: 21 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02836470.