Clinical study to investigate the efficacy and safety of a budesonide suppository for the treatment of acute ulcerative proctitis

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003362-41-DE

Enrollment

320

Registered

2013-04-16

Start date

2013-07-24

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ulcerative proctitis

Interventions

Product Name: Budesonide Pharmaceutical Form: Suppository INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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 =65 years) yes F.1.3.1 Number of subjects for this age range 64

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of this trial are to evaluate the efficacy of two doses of a novel budesonide suppository vs. standard treatment with mesalazine suppository and to evaluate the efficacy of a combined treatment of novel budesonide suppository with standard mesalazine suppository vs. standard mesalazine suppository in patients with acute ulcerative proctitis. ;Secondary Objective: - To evaluate other clinical efficacy endpoints of a treatment of novel budesonide suppository in patients with acute ulcerative proctitis - To assess safety and tolerability in the form of adverse events and laboratory parameters - To assess patients' acceptance of the investigational medicinal product ;Primary end point(s): Time to resolution of clinical symptoms ;Timepoint(s) of evaluation of this end point: Evaluated at the final/withdrawal visit	—

Measure

Time frame

Main Objective: The primary objectives of this trial are to evaluate the efficacy of two doses of a novel budesonide suppository vs. standard treatment with mesalazine suppository and to evaluate the efficacy of a combined treatment of novel budesonide suppository with standard mesalazine suppository vs. standard mesalazine suppository in patients with acute ulcerative proctitis. ;Secondary Objective: - To evaluate other clinical efficacy endpoints of a treatment of novel budesonide suppository in patients with acute ulcerative proctitis - To assess safety and tolerability in the form of adverse events and laboratory parameters - To assess patients' acceptance of the investigational medicinal product ;Primary end point(s): Time to resolution of clinical symptoms ;Timepoint(s) of evaluation of this end point: Evaluated at the final/withdrawal visit

—

Secondary

Measure	Time frame
Secondary end point(s): - Rate of clinical and endoscopic remission - Rate of improvement - Time to resolution of the hallmark symptoms of UC - Rate of patients with mucosal healing ;Timepoint(s) of evaluation of this end point: The rate of clinical and endoscopic remission, improvement and of patients with mocosal healing will be evaluated at the final/withdrawal visit	—

Countries

Germany, Russian Federation, Ukraine

Contacts

Public ContactTrial Manager

proinnovera GmbH

vellmanns@proinnovera-cro.de0049251270778286

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026