drugset / Trial / NCT04100447

A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection

NCT04100447

Phase 1 Completed 11 enrolled Ronald Hurst, MD, FACS
NaSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of LB1148 in subjects undergoing elective bowel resection. During abdominal surgery, surgeons handle, manipulate, and often make incisions in the bowel. These actions can create bruising, lesions, and microscopic damage to the bowel, which may allow digestive enzymes to cross the intestinal mucosal barrier potentially resulting in injury both locally and remotely. Leaking digestive enzymes may delay return of normal gastrointestinal (GI) function, lead to a lack of motility in the intestine (ileus), and promote the formation of intestinal scar tissue (adhesions).

Timeline

Start
2018-11-05
Primary completion
2020-03-20
Completion
2020-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 700 ml Oral

Indications