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

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001921-15-DE

Enrollment

576

Registered

2016-12-09

Start date

2017-03-09

Completion date

Unknown

Last updated

2021-04-12

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

Conditions

Acute Ulcerative Proctitis MedDRA version: 20.1 Level: LLT Classification code 10045368 Term: Ulcerative proctitis System Organ Class: 100000004856

Interventions

Product Name: Budenofalk® suppositories (BUS) Pharmaceutical Form: Suppository INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Other descriptive name: Budenofalk® suppositories (BUS) Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 57

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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, - To assess patients' acceptance and preference of the investigational medicinal products.;Primary end point(s): Rate of clinical remission Rate of mucosal healing ;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment	—

Measure

Time frame

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, - To assess patients' acceptance and preference of the investigational medicinal products.;Primary end point(s): Rate of clinical remission Rate of mucosal healing ;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Rate of patients with clinical remission Rate of patients with mucosal healing Time to resolution of clinical symptoms ;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment	—

Countries

Germany, Hungary, Latvia, Poland, Russian Federation, Slovakia, Ukraine

Contacts

Public ContactDept. of Clinical Research & Develo

Dr. Falk Pharma GmbH

mohrbacher@drfalkpharma.de+497611514156

Outcome results

None listed

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