The Effects of Naltrexone in Active Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores;
研究概览
简要总结
It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the bowel and quality of life in subjects with active Crohn's disease compared to placebo. In order to test this hypothesis the following specific aims are proposed:
- Evaluate the effects of low dose naltrexone compared to placebo on the activity of Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and quality of life surveys;
- Examine the effects of naltrexone given over 3 months compared to 6 months for durability of response;
- Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's disease, and
- Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin levels of subjects on therapy.
Purpose statement: The purpose of this study is to evaluate the effects of low dose naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this compound in those with active Crohn's disease.
详细描述
Study design : The study is designed as a double-blind placebo controlled study for 3 months followed by a pseudo cross-over such that all subjects receiving placebo the first 3 months will receive active drug the second 3 months and all receiving naltrexone the first 3 months remain on the drug the last 3 months of this 6 month study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must give written informed consent
- •Male or female subjects, > 18 years
- •Patients must have endoscopic, histologic, or radiographic confirmed Crohn's Disease.
- •Patients must have a Crohn's Disease Activity Index (CDAI) of at least 220 at Baseline
- •Stable doses of medications for Crohn's disease over proceeding 4 weeks (for aminosalicylates and steroids: prednisone of 10mg or less daily and Entocort 3 mg/ day are allowed), and 12 weeks for azathioprine or 6-mercaptopurine.)
排除标准
- •Subjects with ostomies or ileorectal anastomosis from prior surgical colectomy.
- •Subjects who received infliximab (Remicade) within 8 weeks of study screening or humira for 4 weeks.
- •Subjects requiring steroids either intravenously or prednisone >10mg /day or Entocort > 3 mg daily.
- •Subjects with short-bowel syndrome.
- •Abnormal liver enzymes at screening visit or known hepatitis or cirrhosis
- •Hemoglobin less than
- •Subjects with cancer (other than skin cancer) in past 5 years.
- •Women of childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide), and willing and able to continue contraception for 3 months after the completion of the study.
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
Placebo, Sugar pill
placebo for 3 months blinded then followed by an open-labelled study and all are treated with naltrexone 4.5 mg for 3 additional months
干预措施: Naltrexone-HCl (Drug)
Placebo, Sugar pill
placebo for 3 months blinded then followed by an open-labelled study and all are treated with naltrexone 4.5 mg for 3 additional months
干预措施: Placebo (Drug)
Naltrexone-HCl
Subjects are treated in a blinded fashion for 3 months with naltrexone 4.5 mg po for active Crohn's disease followed an open-labelled study where naltrexone is given an additional 3 months at 4.5 mg po; hence the total treatment interval in this arm is 6 months. The response to the intervention administered is measured in the activity index and mucosal healing by colonoscopy.
干预措施: Naltrexone-HCl (Drug)
结局指标
主要结局
Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores;
时间窗: 3 months
The CDAI score is a number which consists of information collected from a 7-day diary from the patient regarding symptoms. It also includes objective information from the physical exam, weight and hemotocrit. Remission is considered a score of 150 or less. Active disease is considered 220 or greater. A response to therapy is considered a decline in the CDAI score of 70-points from baseline.
次要结局
- Percentage Change From Baseline of Quality of Life IBDQ (Inflammatory Bowel Disease Quality of Life Survey)(Between baseline and 3 months)
- Histology Inflammatory Score by Colon Biopsies(12 weeks)
- Percentage of Patients With a 5 Point Drop in CDEIS Score by Endoscopy(12 weeks)