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Enzyme Inhibitor

LB1148 for Bowel Surgery Recovery (INTEGRITY Trial)

Phase 3

Waitlist Available

Research Sponsored by Palisade Bio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from surgical procedure up to 14 days in hospital

Awards & highlights

INTEGRITY Trial Summary

This trial will test a new drug to see if it is safe and effective in people who are having surgery to remove part of their bowel.

Who is the study for?

This trial is for adults aged 18-80 planning to have elective bowel surgery, who can take oral medication and comply with study procedures. Excluded are those with seizure disorders, severe anesthetic risk (ASA Class IV/V), chronic opioid use, radiation enteritis, or risks related to the drug TXA.Check my eligibility

What is being tested?

The trial tests LB1148's safety and effectiveness in speeding up bowel function recovery after surgery compared to a placebo. Participants will be randomly assigned to receive either LB1148 or a placebo and monitored during their hospital stay.See study design

What are the potential side effects?

Specific side effects of LB1148 aren't listed but generally could include typical drug reactions such as allergic responses, gastrointestinal symptoms like nausea or diarrhea, headaches, or other common medication-related issues.

INTEGRITY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from surgical procedure up to 14 days in hospital

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from surgical procedure up to 14 days in hospital

This trial's timeline: 3 weeks for screening, Varies for treatment, and from surgical procedure up to 14 days in hospital for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to return of gastrointestinal function

Secondary outcome measures

Time discharge order written

Time of actual discharge

Time subject is ready for discharge

+1 more

INTEGRITY Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LB1148Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LB1148

2019

Completed Phase 2

~140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Palisade BioLead Sponsor

1 Previous Clinical Trials

200 Total Patients Enrolled

Media Library

LB1148 (Enzyme Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05470387 — Phase 3

Intestinal Obstruction Research Study Groups: LB1148, Placebo

Intestinal Obstruction Clinical Trial 2023: LB1148 Highlights & Side Effects. Trial Name: NCT05470387 — Phase 3

LB1148 (Enzyme Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05470387 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it legal to market and sell LB1148 in the United States?

"We believe that LB1148 is safe to use (3 out of 3 on our scale) because it has gone through Phase 3 trials. This means that not only is there some evidence that it is effective, but also that it has been tested multiple times for safety."

Answered by AI

Are there any vacancies for clinical trial participants?

"That is right, the clinicaltrials.gov website has the most recent information on this trial's status. According to the site, this study was first posted on 6/28/2022 and is still recruiting participants. There are 23 different hospitals or clinics where patients can enroll, and the goal is to have 600 people total in the trial."

Answered by AI

Is this clinical trial taking place only in the United States or are there other countries involved as well?

"23 medical facilities across the country are recruiting patients for this study. Site 354 in La Jolla, Site 318 in Chapel Hill, and Site 353 in Providence are a few of the participating locations."

Answered by AI

If a patient is 55 or older, are they still able to participate in this research?

"This trial, which has 160 other similar studies for patients over 65 and 50 for those under 18, is looking for patients aged 18 to 80."

Answered by AI

Could you please inform me as to how many individuals are enrolled in this clinical trial?

"Yes, according to the latest information on clinicaltrials.gov, this study is looking for 600 subjects at 23 research sites. The listing was first put up on 6/28/2022 and has since been updated on 10/20/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05470387.