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 577 人开始时间: 2017年1月12日最近更新: 2021年8月24日

研究概览

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•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 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

发起方