A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Unde… (NCT02836470) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection
United States112 participantsStarted 2019-10-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
✕. 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.
✕. 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:
What they're measuring
1
Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo