A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection
- Registration Number
- NCT02836470
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
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.
Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:
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<18 or >80 years of age.
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Requires emergency bowel surgery.
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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.
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American Society of Anesthesiologists (ASA) Class 4 or 5.
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Known inability to take the study drug orally (i.e. complete small bowel obstruction).
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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).
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Has peritoneal carcinomatosis
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History of or current seizure disorder.
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Patients with myeloproliferative disorders.
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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.
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Planned treatment with alvimopan (Entereg®) during study participation period.
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Planned use of 4% icodextrin (Adept®) or SEPRAFILM during the first surgery.
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Received any other investigational therapy within 4 weeks prior to Randomization
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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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Known history of radiation enteritis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo LB1148 LB1148 Active
- Primary Outcome Measures
Name Time Method Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo up to 8 months from the index surgery Extent and severity of intra-abd. adhesions will be determined by the surgeon using the "Intra-Abdominal Adhesion Extent and Severity Assessment Worksheet" with a min. value of zero (0) (better) and a max. value of one hundred and eight (108) (worse). And which records four (4) Sub scores for nine (9) abd. regions which are all summed to make the Total Extent and severity score. Sub scores include: 1) Abd. Wall to Bowel Extent Score (0-3); 2) Abd. Wall to Bowl Severity Score (0-3); Bowel to Bowel (or Viscera) Extent Score (0-3); Bowel to Bowel (or Viscera) Severity Score (0-3); The nine (9) Abd. Regions include: Right upper; Epigastrium; Left upper; Left flank; Left lower; Pelvis; Right lower; Right flank; and Central. Each Sub score is scored with a min. value of zero (0) (better) and a max. value of three (3) (worse); 0=no adhesion; 1=min. (\<1/3 of the site is covered); 2=mod. (1/3 to 2/3 of the site is covered); 3=extensive (\>2/3 of the site is covered).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Site 305
🇺🇸Miami, Florida, United States
Site 311
🇺🇸Houston, Texas, United States
Site 319
🇺🇸Houston, Texas, United States
Site 321
🇺🇸Baltimore, Maryland, United States
Site 331
🇺🇸Miami, Florida, United States
Site 302
🇺🇸Sylmar, California, United States
Site 315
🇺🇸Mobile, Alabama, United States
Site 312
🇺🇸Torrance, California, United States
Site 303
🇺🇸Miami, Florida, United States
Site 324
🇺🇸Burlington, Massachusetts, United States
Site 323
🇺🇸New York, New York, United States
Site 329
🇺🇸Irvine, California, United States
Sie 309
🇺🇸Houston, Texas, United States
Site 310
🇺🇸Pasadena, California, United States
Site 301
🇺🇸Cleveland, Ohio, United States
Site 317
🇺🇸New York, New York, United States
Site 320
🇺🇸Dallas, Texas, United States
Site 325
🇺🇸Rochester, Minnesota, United States
Site 322
🇺🇸Pittsburgh, Pennsylvania, United States
Site 316
🇺🇸Fort Worth, Texas, United States
Site 326
🇺🇸Salt Lake City, Utah, United States
Site 306
🇺🇸Clearwater, Florida, United States
Site 330
🇺🇸Wynnewood, Pennsylvania, United States
Site 307
🇺🇸Yuma, Arizona, United States
Site 308
🇺🇸Orlando, Florida, United States
Site 328
🇺🇸Louisville, Kentucky, United States
Site 318
🇺🇸Chapel Hill, North Carolina, United States
Site 327
🇺🇸Charleston, South Carolina, United States