NCT02836470

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Palisade Bio · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ileus
• Post-Operative Adhesions

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: 2019-10-01
• Primary completion: 2023-09-06
• Completion: 2023-09-08
• First posted: 2016-07-19
• Last updated: 2024-06-21
• Results posted: 2024-06-21

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study