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LB1148 for Bowel Resection (PROFILE Trial)

Phase 2
Waitlist Available
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

Summary

This trial is testing LB1148, a treatment to help patients recover bowel function and reduce internal scar tissue after bowel surgery. It targets patients who are having elective bowel resection surgery. The treatment aims to speed up the return of normal bowel movements and prevent complications from internal scarring.

Eligible Conditions
  • Prevention of Post Operative Ileus
  • Intestinal Obstruction
  • Postoperative Adhesions

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo
Secondary study objectives
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

Side effects data

From 2023 Phase 2 trial • 112 Patients • NCT02836470
21%
nausea
11%
Procedural pain
9%
Hypokalaemia
9%
Urinary retention
9%
Vomiting
7%
Gastrooesophageal reflux disease
7%
Postoperative ileus
5%
Hypomagnesaemia
5%
anemia
5%
Pneumonia
4%
pulmonary embolism
4%
Post operative ileus
4%
gastroesophageal reflux disease
4%
small intestinal obstruction
4%
pyrexia
2%
peritonitis
2%
chest pain
2%
abdominal abscess
2%
pelvic abscess
2%
pneumonia
2%
vascular device infection
2%
procedural pain
2%
Acute kidney injury
2%
Febrile Neutropenia
2%
Acute myocardial infarction
2%
anal fissure
2%
Nephrolithiasis
2%
urinary retention
100%
80%
60%
40%
20%
0%
Study treatment Arm
LB1148
Placebo

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
~250

Find a Location

Who is running the clinical trial?

Leading BioSciences, IncLead Sponsor
2 Previous Clinical Trials
8 Total Patients Enrolled
Palisade BioLead Sponsor
2 Previous Clinical Trials
113 Total Patients Enrolled
Mitch Jones, MDStudy DirectorCMO
1 Previous Clinical Trials
23 Total Patients Enrolled

Media Library

LB1148 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02836470 — Phase 2
Prevention of Post Operative Ileus Research Study Groups: LB1148, Placebo
Prevention of Post Operative Ileus 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
~18 spots leftby Nov 2025
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