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Enzyme Inhibitor

LB1148 for Gastrointestinal Disorders(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
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom surgical procedure up to 14 days in hospital
Awards & highlights
Pivotal Trial

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.

Eligible Conditions
  • Intestinal Obstruction
  • Gastrointestinal Disorder

INTEGRITY Trial Timeline

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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: Placebo, LB1148
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.
~130 spots leftby Jun 2024
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