A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection (PROFILE)

  • STATUS
    Recruiting
  • End date
    Dec 9, 2023
  • participants needed
    200
  • sponsor
    Palisade Bio
Updated on 9 July 2022
laparotomy
abdominal surgery
bowel resection
rectal disease

Summary

The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel resection.

Description

This will be a multicenter, randomized, double-blind, parallel, placebo-controlled, proof-of-concept, adaptive design, Phase 2 study to evaluate LB1148 for return of gastrointestinal function and reduction of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel resection surgery with or without a planned stoma.

Details
Condition Ileus, Post-Operative Adhesions
Treatment Placebo, LB1148
Clinical Study IdentifierNCT02836470
SponsorPalisade Bio
Last Modified on9 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects will be eligible for participation in the study only if they meet ALL of the
following inclusion criteria
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, or rectum is performed for any elected
indication
Planned stoma takedown or other planned abdominal surgery within 8 months of the
initial surgery
Willing to perform and comply with all study procedures including attending clinic
visit as scheduled and completion of a second surgery for stoma takedown or other
abdominal surgery and to determine the presence of intra-abdominal adhesions
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

Exclusion Criteria

<18 or >80 years of age
Requires emergency bowel surgery
Subjects will not be eligible for participation in the study if they meet ANY of the
following exclusion criteria
Has had 1 or more abdominal surgeries, excluding the current, for inflammatory bowel
with
disease, including, but not limited to, inflammatory bowel disease (IBD), Crohn's
Known sensitivity to TXA
Disease, or ulcerative colitis
Recent craniotomy (past 30 days)
Note: This does not apply to previous surgery such as hernia repair unrelated to IBD
Active cerebrovascular bleed
American Society of Anesthesiologists (ASA) Class 4 or 5
Insulin dependent diabetes mellitus
Known inability to take the study drug orally (i.e. complete small bowel obstruction)
Has the following risk factors for thromboembolic disease
Has contraindications or potential risk factors to taking TXA. These include subjects
Sickle cell disease
Nephrotic syndrome
Factor V Leiden
Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism
Prothrombin gene mutation
cerebral thrombosis, ischemic stroke, or acute coronary syndrome)
Protein C or S deficiency
Acute promyelocytic leukemia taking all-trans retinoic acid for remission
Antithrombin III deficiency
induction, or
Antiphospholipid syndrome
Stage IV malignant neoplasm
Continuing use of a combined hormonal contraceptive and or combined hormonal
Neurologic paresis, partial paralysis, or paralysis
replacement therapy (including combined hormonal pill, patch, or vaginal ring)
Pacemaker
Known medical history of congenital or acquired thrombophilia such as, but not
limited to patients with
History of or current seizure disorder
Patients with myeloproliferative disorders
Received any other investigational therapy within 4 weeks prior to Randomization
Known history of radiation enteritis
History of pulmonary embolism, deep vein thrombosis, cerebrovascular accident, or
rental venous/arterial occlusion
Body Mass Index (BMI) >40
Any other condition that, in the opinion of the Investigator, would preclude the
subject from being an appropriate candidate for the study, including severe renal or
hepatic impairment
Planned treatment with alvimopan (Entereg®) during study participation period
Planned use of 4% icodextrin (Adept®) or SEPRAFILM during the first surgery
Chronic opioid usage, defined by the American Pain Society as daily or near-daily use
of opioids for at least 90 days
Female subjects of childbearing potential with a positive urine or serum pregnancy
test or who are not taking (or not willing to take) acceptable birth control measures
(abstinence, intrauterine devices, contraceptive implants or barrier methods) through
Day 30. Additionally, those women who are lactating and insist on breast feeding
within 5 days of the last dose of study drug
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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