NL-OMON52463尚未招募2 期
ow Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn*s Disease that failed conventional treatment - The LDN Crohn study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 122
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age 18 or older; must have the ability to understand and sign a written ICF
- •Diagnosis of Crohn*s disease >=3 months before screening.
- •Objective evidence of inflammation at baseline as defined by endoscopy with
- •mucosal ulcers in the ileum or colon or both, and a SES-CD score of 3-15.
- •Concurrent therapies with stable doses of azathioprine, mercaptopurine, MTX
- •or steroids
排除标准
- •Current use of i.v. corticosteroids.
- •Imminent need for in-hospital treatment.
- •Pregnancy or lactation.
- •Current treatment with investigational drug; current or past treatment within
- •3 months prior to randomization with a biological agent.
- •Stool sample positive for Clostridium difficile (C. diff) toxin, pathogenic
- •Escherichia coli (E. coli), Salmonella species (spp), Shigella spp,
- •Campylobacter spp, or Yersinia spp.
- •Other significant illnesses that may interfere with the study, stricture
- •causing obstructive symptoms, or fistulising disease complicated by infection.
- •Opiates use or drugs and/or alcohol abuse.
研究者
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