Randomized, double-blind, multicentre study to compare the efficacy and safety of two different dosages of a novel budesonide suppository versus a mesalazine suppository versus a combination therapy of budesonide/mesalazine suppositories in patients with acute ulcerative proctitis

Dr. Falk Pharma GmbH0 个研究点目标入组 337 人开始时间: 2013年4月16日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•- Man or woman between 18 and 75 years of age
•- Active ulcerative proctitis, i.e. extent of inflammation = 15 cm from the anal margin
•- Diagnosis confirmed by endoscopy (at least one total colonoscopy in the disease history)
•- Established disease or new diagnosis
•- Mildly to moderately active ulcerative proctitis (3 < modified UC-DAI < 11) with endoscopic subscore of = 1
•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 256
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 64

•- Crohn’s disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular associated colitis, microscopic colitis
•- Presence of proctitis of a different origin (e.g. infectious or parasitic, drug-induced)
•- Prior bowel resection leading to diarrhoea and/or pouch formation
•- Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids 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 month prior to baseline
•- Existing or intended pregnancy or breast-feeding
•-Participation in another clinical trial within the last 30 days and having received IMP, simultaneous participation in another clinical trial, or previous participation in this trial and having received IMP

发起方