Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease in Adults
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 98
- 试验地点
- 12
- 主要终点
- Change in Crohn's Disease Activity Index (CDAI)
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of nitazoxanide compared to a placebo in reducing the signs and symptoms of mild to moderate active Crohn's disease in adults.
详细描述
There is a significant need for a safe and effective treatment of Crohn's disease. It is recognized that bacteria in the gut lumen may have a role in the etiology and/or symptoms of this disease. Antimicrobials have often been used in treating Crohn's disease although their effectiveness has not been well established. Pro-inflammatory cytokines are also believed to play an important role in this disease. Nitazoxanide, a thiazolide anti-infective, is active in vitro against a broad spectrum of anaerobic bacteria, and it inhibits secretion of pro-inflammatory cytokines including IL-2, -4, -5, -6, -8, -10 and TNF alpha. The drug is also highly concentrated in the gastrointestinal tract. With these characteristics, nitazoxanide offers a unique approach to treatment of Crohn's disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Diagnosis of Crohn's disease with colonic or perianal involvement confirmed by endoscopic, histologic and/or radiologic data.
- •CDAI score ≥200 and ≤400.
排除标准
- •Subjects known to have stool positive for Clostridium difficile toxin A or B, bacterial enteric pathogens, rotavirus, Cryptosporidium species (spp.), and/or ova/parasites.
- •Evidence of bowel obstruction.
- •Females that are pregnant, breast-feeding or not using birth control and are sexually active.
- •Serious systemic disorders incompatible with the study.
- •History of hypersensitivity to nitazoxanide or any inactive ingredient in the formulation.
- •Uncontrolled gastro-intestinal bleeding.
- •Evidence of intestinal abscess, non-perianal fistula or stricture.
- •Patients who have received antibiotics in the past 7 days.
- •Patients receiving >20 mg of prednisone, or its equivalent.
- •Patients receiving Anucort-HC or rectal steroids.
- •Patients receiving immunosuppressive therapy that has not been stabilized.
- •Patients who have received TNF-alpha inhibitor treatments such as infliximab or other biological agents within three months prior to start of treatment.
- •Patients with Crohn's disease confined to the esophagus, stomach and small bowel.
研究组 & 干预措施
1
One nitazoxanide 500 mg tablet twice daily for 28 days
干预措施: Nitazoxanide (Drug)
2
One placebo tablet twice daily for 28 days
干预措施: Placebo (Other)
结局指标
主要结局
Change in Crohn's Disease Activity Index (CDAI)
时间窗: Day 14
次要结局
- Clinical response; remission; change in C-reactive protein; reduction in steroid use; fistula response; change in Perianal Disease Activity Index (PDAI); change in plasma cytokine levels(Days 14 and 28)