A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elect… (NCT04100447) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection
United States11 participantsStarted 2018-11-05
Plain-language summary
The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of LB1148 in subjects undergoing elective bowel resection. During abdominal surgery, surgeons handle, manipulate, and often make incisions in the bowel. These actions can create bruising, lesions, and microscopic damage to the bowel, which may allow digestive enzymes to cross the intestinal mucosal barrier potentially resulting in injury both locally and remotely. Leaking digestive enzymes may delay return of normal gastrointestinal (GI) function, lead to a lack of motility in the intestine (ileus), and promote the formation of intestinal scar tissue (adhesions).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Scheduled to undergo an elective (non-emergent) bowel resection. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elected indication.
✓. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
Exclusion criteria
✕. Subjects who are \< 18 or \> 85 years of age.
✕. Subjects who require emergency bowel surgery.
✕. Subjects who have had 2 or more abdominal surgeries, excluding the current, for inflammatory bowel disease (IBD), including, but not limited to, IBD, Crohn's Disease, or ulcerative colitis. Note: This does not apply to previous surgeries such as hernia repair unrelated to IBD.
✕. Subjects who meet the American Society of Anesthesiologists (ASA) definition for Class 4 or 5 disease.
✕. Known inability to take the study drug orally (i.e. complete small bowel obstruction).
✕. Subjects with contraindications or potential risk factors to taking TXA. These include:
What they're measuring
1
The number of participants who experience treatment-emergent adverse events (TEAEs)
Timeframe: From first study drug dosing through Day 30