NCT05470387终止3 期
A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of LB1148 in Accelerating the Time to Return of Bowel Function in Subjects Undergoing Planned Bowel Resection (INTEGRITY)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Palisade Bio
- 入组人数
- 23
- 试验地点
- 23
- 主要终点
- Time to Return of Gastrointestinal Function
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
详细描述
This will be a multicenter, randomized, double-blind, placebo-controlled, study to evaluate the safety and efficacy of LB1148 in return to bowel function for subjects undergoing planned bowel resection.
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
- Triple (Participant, Care Provider, Investigator)
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:
- •Adults age 18 to 80 years, inclusive.
- •Scheduled to undergo a planned (non-emergent) bowel resection via minimally invasive technique or laparotomy. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elective indication.
- •Willing to perform and comply with all study procedures including, being hospitalized until achieving GI-2 and responding to telephone follow-up visits as scheduled.
- •Willing and able to provide 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:
- •History of total colectomy.
- •Has a preexisting ostomy.
- •History of radiation enteritis.
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m
- •History of seizure disorder.
- •History of myeloproliferative disorders.
- •American Society of Anesthesiologists (ASA) Class IV or V.
- •Inability to take IP orally or consume solid food.
- •Planned treatment with alvimopan (Entereg®) during hospitalization period
- •Chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.
- •Men and women of child bearing potential (WOCBP) who are unwilling to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods (but not combination hormonal methods), intrauterine device, or use of spermicide combined with a barrier method (e.g., condom, diaphragm) for 28 days before Day 1 and through Day
- •Women who will not agree to stop combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch or vaginal ring) during the 7 day period prior to Surgery (Study Day 2) through the 7 day period following surgery (Study Days 3 through 9).
- •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
- •Receipt of any investigational drug within 28 days or 5 half-lives prior to Day
- •Any other condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements.
研究组 & 干预措施
LB1148
Experimental
干预措施: LB1148 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Return of Gastrointestinal Function
时间窗: From surgical procedure up to 14 days in hospital
The later of the times in hours from placement of the last skin staple or suture to the time of toleration of solid food (defined as the time a subject finished a meal that required chewing and experienced no significant nausea/vomiting for 4 hours after the solid meal) and the first bowel movement, up to 14 days post-surgery
次要结局
- Time Subject is Ready for Discharge(From surgical procedure up to 14 days in hospital)
- Time of Actual Discharge(From surgical procedure up to 14 days in hospital)
- Time Discharge Order Written(From surgical procedure up to 14 days in hospital)
- Time to First Bowel Movement(From surgical procedure up to 14 days in hospital)
研究者
研究点 (23)
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