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

NCT02836470 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-06-21

Study results available
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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.

Conditions

  • Ileus
  • Post-Operative Adhesions

Interventions

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.

Sponsors & Collaborators

  • Palisade Bio

    lead INDUSTRY

Principal Investigators

  • Mitch Jones, MD · CMO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2023-09-06
Completion
2023-09-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02836470 on ClinicalTrials.gov