EUCTR2016-001921-15-HU进行中（未招募）1 期
Randomised, double-blind, double-dummy, multicentre study to compare the efficacy and safety of once daily novel 4 mg budesonide suppository versus once daily 2 mg budesonide foam in patients with acute ulcerative proctitis - Novel budesonide suppository vs. budesonide foam in acute ulcerative proctitis.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 576
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
- •Man or woman between 18 and 75 years of age,
- •Acute ulcerative proctitis,
- •Diagnosis confirmed by total colonoscopy or flexible sigmoidoscopy
- •New diagnosis or established disease
- •Mildly to moderately active ulcerative proctitis (3 < modified UC-DAI <
- •11) with rectal bleeding subscore of = 1 and endoscopic subscore of = 2,
- •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 519
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 57
排除标准
- •Crohn's disease, indeterminate colitis, ischemic colitis, diverticular
- •associated colitis, microscopic colitis,
- •Presence of proctitis of a different origin (e.g. infectious or parasitic,
- •drug-induced),
- •Previous colonic surgery (except appendectomy, haemorrhoidectomy,
- •and endoscopic removal of polyps),
- •Presence of symptomatic organic disease of the gastrointestinal tract
- •(with the exception of non-bleeding haemorrhoids or hiatal hernia),
- •Local intestinal infection (i.e. pathogenic bacteria or Clostridium difficile
- •toxin in stool culture),
- •Oral/rectal/intravenous corticosteroids therapy within the last 4 weeks
- •prior to baseline,
- •Existing or intended pregnancy or breast-feeding,
- •Participation in another clinical trial within the last 30 days prior to
- •screening and having received IMP, simultaneous participation in
- •another clinical trial, or previous participation in this trial and having
- •received IMP
研究者
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