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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Palisade Bio
- 入组人数
- 112
- 试验地点
- 28
- 主要终点
- Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
- •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.
研究组 & 干预措施
LB1148
Active
干预措施: LB1148 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo
时间窗: 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).
次要结局
未报告次要终点