EUCTR2006-004230-32-IT进行中（未招募）不适用
Efficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETA
CHIESI0 个研究点目标入组 300 人开始时间: 2007年11月12日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •Screening visit -Male or female >18 or <70 years old. -Female patients surgically sterilised or in post-menopausal period from at least 12 months or prepared to practise a birth control from the screening up to 30 days from the last dose. -History of ulcerative colitis dated mote than 3 months. -Oral Mesalazine (if current therapy) at stable dose in the last 14 days at maximum dose of 3.2 g/day, or balsalazide 6.75 g/day, or salazine 2 g/day, sulfasalazine 3 g/day Randomisation visit -Endoscopic score > or equal 1, confirmation of active ulcerative colitis -DAI > or equal to 3 and <10 -Rectal bleeding score > or equal to 1 -Negative pregnancy test
- •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
- •Severe ulcerative colitis,toxic megacolon, infectiuos colitis, ischemic colitis, colitis induced by drugs or radiotherapy. -Crohn? s disease. -Major gastrointestinal surgery. -Peptic ulcer. -Non compensated diabetes mellitus. -Non controlled hypertension. -Hyperthyroidism. -Cancer. -Patients that have received investigational new drugs within the last 12 weeks. -Positive stool examination for parassites and ova. -Significant hepatic or renal impairment.
研究者
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