EUCTR2004-004083-77-SK进行中（未招募）1 期
A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease
Disphar International B.V.0 个研究点目标入组 436 人开始时间: 2005年1月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 436
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To participate in this trial, patients will have to meet all of the following criteria:
- •-established diagnosis of Crohn disease in Moderate active status verified by clinical evaluation, laboratory tests and by X-ray examination or/and colonoscopy and histology
- •-Crohn disease of at least 3 months duration
- •-acute exacerbation of moderate Crohn disease with a CDAI score between 220–400 points
- •-patients between 18–75 years, both sexes
- •-written informed consent obtained
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any of the following criteria will be excluded from participation in this study:
- •-positive stool culture for enteric pathogens including Salmonella, Shigella, Yersinia or Campylobacter
- •-pregnant or lactating women
- •-women of child bearing potential not taking adequate contraceptive precautions
- •-maintenance treatment with higher daily doses (orally or rectally) than 4 g of Sulfasalazine or 2 g of Mesalazine EC 500 mg or any derivative up to one month before entering the study
- •-chronic use of any anti-inflammatory drugs, including NSAID´s (rectally or orally) within 7 days prior to inclusion; chronic use is defined as intake of medication every day for more than 7 consecutive days
- •-chronic administration of any steroids is an exclusion criterion within 7 days before entering the study
- •-chronic administration of any immunosuppressive agents is an exclusion criterion within 3 months before entering the study
- •-any other disease or condition which may interfere with study assessments as judged by the investigator
- •-alcohol or drug abuse
- •-patients taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months
- •-patients allergic to aspirin or other salicylates
- •-clinically significant renal/hepatic impairment or serious heartdisease
- •-patients presenting any malignant disease
- •-patients likely not to comply with the study procedures
- •-patients with any kind of stomy and after subtotal colectomy and with ileorectal anastomosis
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