EUCTR2016-001170-15-ES进行中（未招募）1 期
Efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course in comparison with monotherapy oral corticosteroid course for moderate flares of ulcerative colitis: a randomized multicentre clinical trial - CECUM
GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa)0 个研究点目标入组 148 人开始时间: 2017年8月2日最近更新:
适应症
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
- 148
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
- •- Ulcerative colitis diagnosis by Lennard-Jones criteria
- •- =18 years
- •- Left or extended extent of disease
- •- Moderate flares of ulcerative colitis according to disease activity index (DAI)
- •- No maintenance therapy or 5ASA treatment
- •- The patient is available to understand study procedures and to sign the inform consent form
- •- Inform Consent Form
- •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 148
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Previous or current thiopurines, methotrexate or biological treatment
- •- Administration of systemic corticoids the last 6 months
- •- Acute or moderate systemic infection
- •- Diabetes mellitus or arterial hypertension
- •- Pregnancy or breastfeeding
- •- Allergic reactions associated to corticosteroids therapy
研究者
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