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.

Dr. Falk Pharma GmbH0 个研究点目标入组 576 人开始时间: 2017年3月17日最近更新: 2020年9月28日

研究概览

暂无简介。

•- 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

•- 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 and having received IMP within the last 30 days prior to screening or within 5-half-lives of IMP (whichever is longer), simultaneous participation in another clinical trial, or previous participation in this trial and having received IMP.

发起方