NCT05470387

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

A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of LB1148 in Accelerating the Time to Return of Bowel Function in Subjects Undergoing Planned Bowel Resection (INTEGRITY)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Palisade Bio · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.

Detailed description

This will be a multicenter, randomized, double-blind, placebo-controlled, study to evaluate the safety and efficacy of LB1148 in return to bowel function for subjects undergoing planned bowel resection.

Conditions

• Ileus
• Gastro-Intestinal Disorder

Interventions

Type	Name	Description
DRUG	LB1148	A total of 700 mL of drug product will be administered orally as a split dose before surgery.
DRUG	Placebo	A total of 700 mL of placebo will be administered orally as a split dose before surgery.

Timeline

• Start date: 2022-06-28
• Primary completion: 2023-03-06
• Completion: 2023-08-11
• First posted: 2022-07-22
• Last updated: 2024-06-13
• Results posted: 2024-06-13

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study