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LB1148 for Bowel Resection (PROFILE Trial)

Phase 2
Recruiting
Research Sponsored by Leading BioSciences, Inc
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 up to 8 months from the index surgery
Awards & highlights

PROFILE Trial Summary

This trial will test a new drug to see if it is effective in treating post-operative ileus and intra-abdominal adhesions.

Eligible Conditions
  • Intestinal Obstruction
  • Postoperative Adhesions

PROFILE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months from the index surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 months from the index surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tissue Adhesions
Secondary outcome measures
Hospital length of stay
Incidence of intra-abdominal adhesions
Time from surgical closure to resolution or appearance, as appropriate, of 1 or more of the components common to GI dysfunction following elective bowel resection with or without a planned stoma
+3 more

PROFILE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LB1148Experimental Treatment1 Intervention
Active
Group II: PlaceboPlacebo Group1 Intervention
Placebo
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?

Leading BioSciences, IncLead Sponsor
2 Previous Clinical Trials
8 Total Patients Enrolled
Palisade BioLead Sponsor
1 Previous Clinical Trials
600 Total Patients Enrolled
Bert Slade, MDStudy DirectorPalisade Bio

Media Library

LB1148 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02836470 — Phase 2
Intestinal Obstruction Research Study Groups: LB1148, Placebo
Intestinal Obstruction Clinical Trial 2023: LB1148 Highlights & Side Effects. Trial Name: NCT02836470 — Phase 2
LB1148 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02836470 — Phase 2

Frequently Asked Questions

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

Is this research project open to people who are older than 65 years of age?

"This particular trial only enrolls patients that are 18-80 years old. There are other trials, however, 6 of which cater to a younger demographic and 26 for seniors."

Answered by AI

Are there different research hospitals participating in this trial across Canada?

"Currently, this study is active at 28 sites, including Site 331 in Miami, Site 321 in Baltimore, and Site 329 in Irvine."

Answered by AI

Could you explain the requirements for subjects in this experiment?

"This trial is looking for 200 participants, within the ages of 18 and 80 who have ileus. It is important that participants also meet the following criteria: Planned stoma takedown or other planned abdominal surgery within 8 months of the initial surgery., Has been informed of the nature of the study (either the subject or their legal representative), agrees to its provisions, and has provided written informed consent., Scheduled to undergo an elective (non-emergent) bowel resection with a planned stoma via laparotomy or minimally invasive technique. This includes any subject in which a resection of the small intestine, colon"

Answered by AI

If LB1148 is not properly administered, could patients be harmed?

"LB1148 scored a 2 for safety. Phase 2 trials have some data supporting safety, but no efficacy data is available yet."

Answered by AI

Are we still recruiting patients for this research project?

"The study is recruiting patients, as reported on clinicaltrials.gov. The study was first posted on 10/1/2019 and last updated on 10/27/2022."

Answered by AI

Could you give an estimate of how many people are participating in this clinical trial?

"In order to properly run this experiment, the research team needs at least 200 individuals that fit the pre-determined criteria. If chosen, patients will visit one of two sites: Site 331 in Miami, Florida or Site 321 which is located in Baltimore, Maryland."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Site 322
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection
2019. "A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02836470.
~36 spots leftby May 2025
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