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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 : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Leading BioSciences, Inc

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 : 120 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 : September 2020
Estimated Study Completion Date : March 2021

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. 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).


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 ]
  2. 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

  3. Time to resolution of post-operative ileus [ Time Frame: From surgical closure up to 14 days in hospital ]
  4. Hospital length of stay [ Time Frame: From surgical closure up to 14 days in hospital ]


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 or without 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. 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. Insulin dependent diabetes mellitus.
  6. Known inability to take the study drug orally (i.e. complete small bowel obstruction).
  7. 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).
  8. Has the following risk factors for thromboembolic disease:

    1. Known medical history of congenital or acquired thrombophilia such as, but not limited to patients with:

      • Sickle cell disease;
      • Nephrotic syndrome;
      • Factor V Leiden;
      • Prothrombin gene mutation;
      • Protein C or S deficiency;
      • Antithrombin III deficiency;
      • Antiphospholipid syndrome.
    2. Stage IV malignant neoplasm;
    3. Neurologic paresis, partial paralysis, or paralysis;
    4. Pacemaker;
    5. History of pulmonary embolism, deep vein thrombosis, cerebrovascular accident, or rental venous/arterial occlusion;
  9. History of or current seizure disorder.
  10. Patients with myeloproliferative disorders.
  11. Body Mass Index (BMI) >40.
  12. 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.
  13. Planned treatment with alvimopan (Entereg®) during study participation period.
  14. Received any other investigational therapy within 4 weeks prior to Randomization
  15. Chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.
  16. 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.
  17. 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: Thomas M Hallam, PhD 858-704-4900 tom.hallam@leadingbiosciences.com
Contact: Inge K Bear, MS, CCRA 858-704-4900 inge.bear@leadingbiosciences.com

Locations
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United States, Arizona
Yuma Regional Medical Center Recruiting
Yuma, Arizona, United States, 85364
Contact: Bharat Magu, MD    928-336-7015    bmagu@yumaregional.org   
Contact: Yesenia Zambrano    928-336-3364    yzambrano@yumaregional.org   
United States, California
Lotus Clinical Research Recruiting
Pasadena, California, United States, 91105
Contact: Alina Beaton, MD    626-397-5281    abeaton@lotuscr.com   
Contact: Jose Martinez    626-568-8727    jmartinez@lotuscr.com   
Olive View-UCLA Medical Center Recruiting
Sylmar, California, United States, 91342
Contact: Darin Saltzman, MD    747-210-3194    dsaltzman@dhs.lacounty.gov   
Contact: Kavitha Pathmarajah    747-210-3115    kpathmarajah@dhs.lacounty.gov   
Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Beverly Petrie, MD       bpetrie@dhs.lacounty.gov   
Contact: Dyonne Tetangco    310-735-3489    d.tetangco@labiomed.org   
United States, Florida
Research Alliance Inc. Recruiting
Clearwater, Florida, United States, 33756
Contact: Lourdes Santiago, MD    727-631-0779    lourdesterry@mac.com   
Contact: Bridget Hester    727-631-0779    bridget@researchalliance.net   
Columbus Clinical Recruiting
Miami, Florida, United States, 33125
Contact: Manuel Viamonte, MD    305-631-6991    m.viamonte@columbusclinical.net   
Contact: Lazaro Cruz    305-631-6991    lazaro.cruz@columbusclinical.com   
International Research Associates Recruiting
Miami, Florida, United States, 33142
Contact: Christian Breton, MD    305-670-8830    cbreton@intrallc.com   
Contact: Juan Calderon, MD    305-670-8830    jcalderon@intrallc.com   
Advent Health Center for Colon & Rectal Surgery Recruiting
Orlando, Florida, United States, 32804
Contact: John Monson, MD    407-303-2615    john.monson.md@adventhealth.com   
Contact: Sarah George    407-303-2800 ext 1103878    sarah.a.george@adventhealth.com   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: David Liska, MD    216-444-9212    liskad@ccf.org   
Contact: Abraham Oluwasanmi    216-442-5382    oluwasm@ccf.org   
United States, Texas
Memorial Hermann Memorial City Recruiting
Houston, Texas, United States, 77024
Contact: Alan Skolnick, MD    713-480-3028    drskolnick@researchhd.com   
Contact: Jayme Carr    832-524-7177    jayme@researchhd.com   
Memorial Hermann Southeast Recruiting
Houston, Texas, United States, 77089
Contact: Ori Hampel, MD    713-477-8600      
Contact: Amber Riveria    832-748-1074    amber@researchhd.com   
Sponsors and Collaborators
Leading BioSciences, Inc
Investigators
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Study Director: Michael J Dawson, MD Leading BioSciences, Inc
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Responsible Party: Leading BioSciences, Inc
ClinicalTrials.gov Identifier: NCT02836470    
Other Study ID Numbers: LBS-POI-201
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
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 Leading BioSciences, Inc:
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