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)

Palisade Bio23 sites in 1 country23 target enrollmentJune 28, 2022

ConditionsIleus Gastro-Intestinal Disorder

InterventionsLB1148 Placebo

DrugsLB1148 Placebo

Overview

Phase: Phase 3
Intervention: LB1148
Conditions: Ileus
Sponsor: Palisade Bio
Enrollment: 23
Locations: 23
Primary Endpoint: Time to Return of Gastrointestinal Function
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 28, 2022

End Date

August 11, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Palisade Bio

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:
•Adults age 18 to 80 years, inclusive.
•Scheduled to undergo a planned (non-emergent) bowel resection via minimally invasive technique or laparotomy. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elective indication.
•Willing to perform and comply with all study procedures including, being hospitalized until achieving GI-2 and responding to telephone follow-up visits as scheduled.
•Willing and able to provide written informed consent.

Exclusion Criteria

•Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:
•History of total colectomy.
•Has a preexisting ostomy.
•History of radiation enteritis.
•Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m
•History of seizure disorder.
•History of myeloproliferative disorders.
•American Society of Anesthesiologists (ASA) Class IV or V.
•Inability to take IP orally or consume solid food.
•Planned treatment with alvimopan (Entereg®) during hospitalization period

Arms & Interventions

LB1148

Intervention: LB1148

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Time to Return of Gastrointestinal Function

Time Frame: From surgical procedure up to 14 days in hospital

The later of the times in hours from placement of the last skin staple or suture to the time of toleration of solid food (defined as the time a subject finished a meal that required chewing and experienced no significant nausea/vomiting for 4 hours after the solid meal) and the first bowel movement, up to 14 days post-surgery

Secondary Outcomes

Time Subject is Ready for Discharge(From surgical procedure up to 14 days in hospital)
Time of Actual Discharge(From surgical procedure up to 14 days in hospital)
Time Discharge Order Written(From surgical procedure up to 14 days in hospital)
Time to First Bowel Movement(From surgical procedure up to 14 days in hospital)