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

Phase 1

• Conditions: Acute Ulcerative Proctitis; MedDRA version: 20.1Level: LLTClassification code 10045368Term: Ulcerative proctitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-001921-15-DE
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-09
• Last Update Posted: 12 April 2021

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 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

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