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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836470
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
Palisade Bio

Brief 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.

Condition or disease Intervention/treatment Phase
Ileus Post-Operative Adhesions Drug: LB1148 Drug: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate LB1148 for Return of Gastrointestinal Function, Post-Operative Ileus and Intra-Abdominal Adhesions in Subjects Undergoing Elective Bowel Resection
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: LB1148
Active
Drug: LB1148
A total of 700 mL of drug product will be administered orally as a split dose before surgery.
Other Name: Active

Placebo Comparator: Placebo
Placebo
Drug: Placebo
A total of 700 mL of placebo will be administered orally as a split dose before surgery.




Primary Outcome Measures :
  1. Change from baseline in extent and severity of intra-abdominal adhesions among subjects treated with LB1148 or placebo [ Time Frame: up to 8 months from the index surgery ]
    Extent and severity of intra-abdominal adhesions will be determined by the surgeon using the Intra-Abdominal Adhesion Extent and Severity Assessment Worksheet


Secondary Outcome Measures :
  1. 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 [ Time Frame: From surgical closure up to 14 days in hospital ]
    Compare time from surgical closure to resolution or appearance, as appropriate, of 1 or more of the components common to gastrointestinal (GI) dysfunction following elective bowel resection with a planned stoma.

  2. Time to return of gastrointestinal function as defined by achieving GI2 [ Time Frame: From surgical closure up to 14 days in hospital ]
    GI2 is a composite endpoint defined as the time from the end of surgery to the time of recovery of the upper GI tract (toleration of solid food) and the time to recovery of the lower GI tract (first bowel movement).

  3. Time to Achieve GI-3 [ Time Frame: From surgical closure up to 14 days in hospital ]
    GI3 is defined as the toleration of solid food and either first flatus or bowel movement

  4. Time to resolution of post-operative ileus [ Time Frame: From surgical closure up to 14 days in hospital ]
    Compare number of hours to resolution of POI.

  5. Hospital length of stay [ Time Frame: From surgical closure up to 14 days in hospital ]
    Compare hospital length of stay (LOS, recorded in hours) through Discharge or Day 14 (whichever comes first).

  6. Incidence of intra-abdominal adhesions [ Time Frame: up to 8 months from the index surgery ]
    Compare the incidence of intra-abdominal adhesions following the second surgery among subjects treated with LB1148 or placebo.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:

  1. 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.
  2. Planned stoma takedown or other planned abdominal surgery within 8 months of the initial surgery.
  3. 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.
  4. 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:

Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:

  1. <18 or >80 years of age.
  2. Requires emergency bowel surgery.
  3. Has had 1 or more abdominal surgeries, excluding the current, for inflammatory bowel disease, including, but not limited to, inflammatory bowel disease (IBD), Crohn's Disease, or ulcerative colitis.

    Note: This does not apply to previous surgery such as hernia repair unrelated to IBD.

  4. American Society of Anesthesiologists (ASA) Class 4 or 5.
  5. Known inability to take the study drug orally (i.e. complete small bowel obstruction).
  6. Has contraindications or potential risk factors to taking TXA. These include subjects with:

    1. Known sensitivity to TXA;
    2. Recent craniotomy (past 30 days);
    3. Active cerebrovascular bleed;
    4. Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome);
    5. Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction, or
    6. Continuing use of a combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch, or vaginal ring).
  7. Has peritoneal carcinomatosis
  8. History of or current seizure disorder.
  9. Patients with myeloproliferative disorders.
  10. 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.
  11. Planned treatment with alvimopan (Entereg®) during study participation period.
  12. Planned use of 4% icodextrin (Adept®) or SEPRAFILM during the first surgery.
  13. Received any other investigational therapy within 4 weeks prior to Randomization
  14. 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.
  15. Known history of radiation enteritis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836470


Contacts
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Contact: Nick McCoy 214-457-1996 nick.mccoy@palisadebio.com

Locations
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Sponsors and Collaborators
Palisade Bio
Investigators
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Study Director: Michael J Dawson, MD Palisa
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Responsible Party: Palisade Bio
ClinicalTrials.gov Identifier: NCT02836470    
Other Study ID Numbers: LBS-POI-201
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Palisade Bio:
Post-operative Ileus
Post-Operative Abdominal Adhesions
Return of Gastrointestinal Function
Anastomosis
Enterotomy
Enterostomy
Colorectal Surgery
Intestines Surgery
Additional relevant MeSH terms:
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Ileus
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases