Trial | NCT02836470  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    200
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.
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.
Study Started
Oct 01
2019
Primary Completion
Jun 30
2023
Anticipated
Study Completion
Dec 31
2023
Anticipated
Last Update
Oct 31
2022

Drug LB1148

A total of 700 mL of drug product will be administered orally as a split dose before surgery.

  • Other names: Active

Drug Placebo

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

LB1148 Experimental

Active

Placebo Placebo Comparator

Placebo

Criteria 

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:

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

<18 or >80 years of age.
Requires emergency bowel surgery.

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.

American Society of Anesthesiologists (ASA) Class 4 or 5.
Known inability to take the study drug orally (i.e. complete small bowel obstruction).

Has contraindications or potential risk factors to taking TXA. These include subjects with:

Known sensitivity to TXA;
Recent craniotomy (past 30 days);
Active cerebrovascular bleed;
Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome);
Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction, or
Continuing use of a combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch, or vaginal ring).
Has peritoneal carcinomatosis
History of or current seizure disorder.
Patients with myeloproliferative disorders.
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.
Received any other investigational therapy within 4 weeks prior to Randomization
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.
Known history of radiation enteritis.
No Results Posted