Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in daily 24 hr ileostomy collection
研究概览
简要总结
The objective of the study is to investigate the natural history of patients with a temporary ileostomy and to assess the effect of Teduglutide in reducing morbidity, hospital readmissions and post reversal complications.
详细描述
This is a prospective, controlled, randomized, double blind study. A total of 36 subjects will be enrolled into the study. Subjects will be randomized to receive Teduglutide or Placebo for 12 weeks or until the ileostomy is reversed. Teduglutide or placebo will be administered via a daily subcutaneous injection into the abdomen or thigh. The sites will be rotated with each injection. If adverse effects develop the subjects will be permitted to hold drug administration for a maximum of 5 days in total during the 12-week study.
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)
盲法说明
The drug will be delivered to the patient according to the randomization scheme and neither the patient nor the investigators will know which patient is randomized into which group until the study is completed. Only the pharmacist at the AHN pharmacy will know the patient assigned to each group.
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
- •Patients who are undergoing temporary ileostomy (loop or end ileostomy) regardless of the indication or technique used (open or laparoscopy) as part of their regular standard of care
- •Age- 18-80 years old
- •Normal routine laboratories (CMP, CBC, CRP, amylase, lipase)
- •Permitted medications will include biologicals which dose has not been changed for > 6 months, and immunosuppressant therapy which dose has not been changed for 3 months (i.e. codeine sulfate, loperamide, or Lomotil)
排除标准
- •Emergency need for ileostomy
- •Pregnant or nursing
- •Malnutrition or requiring parenteral or enteral nutrition
- •Known intestinal obstruction, stricture, or adhesions that would predispose the patient to the development of intestinal obstruction, perforation, hemorrhage, or intestinal abscess
- •Intestinal fistulas or abscess proximal to the ostomy
- •Small bowel resection greater than 50 cm.
- •Clinically significant cardiovascular, renal, pulmonary, endocrine, immunologic, dermatology, neurological or psychiatric disorders
- •Cholelithiasis or pancreatitis
- •Family history of colorectal cancer or familial polyposis
- •Cancer in the last 5 years
- •History of HIV, Hepatitis B or C, or other acute systemic or intestinal infections requiring antibiotics
- •Use of GLP1 analogues which may increase the risk of acute pancreatitis
- •Treatment of Octreotide
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Teduglutide
Teduglutide 0.05 g/kg/day
干预措施: Teduglutide (Drug)
结局指标
主要结局
Change in daily 24 hr ileostomy collection
时间窗: Change from time of surgery to 12 weeks
(mL/day)
次要结局
未报告次要终点
研究者
James McCormick, DO
Principal Investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)