ovel budesonide suppository vs. budesonide foam in acute ulcerative proctitis.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 576

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To prove the non-inferiority of an 8-week treatment with once-daily 4 mg budesonide suppository vs. active comparator 2 mg budesonide foam in patients with acute ulcerative proctitis.;Secondary Objective: - To assess safety and tolerability in the form of adverse events and laboratory parameters,<br>- To assess patients' acceptance and preference of the investigational medicinal products.;Primary end point(s): - Rate of clinical remission <br>- Rate of mucosal healing ;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Rate of patients with clinical remission <br>- Rate of patients with mucosal healing <br>- Time to resolution of clinical symptoms<br>;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment

Related Trials