acute ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Product Name: Budenofalk® suppositories
Pharmaceutical Form: Suppository
INN or Proposed INN: BUDESONIDE
CAS Number: CAS-51333-22
Other descriptive name: Budenofalk® suppositories (BUS)
Concentration
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed informed consent, Man or woman between 18 and 75 years of age, Acute ulcerative colitis, New diagnosis or established disease, diagnosis confirmed by total colonoscopy and biopsy Mildly to moderately active ulcerative colitis (3 =65 years) yes F.1.3.1 Number of subjects for this age range 78
Exclusion criteria
Exclusion criteria: Crohn’s disease, indeterminate colitis, ischemic colitis, diverticular disease-associated colitis, microscopic colitis Presence of colitis of a different origin (e.g. infectious or parasitic, drug-induced), Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps), Abnormal laboratory values, presence of or suspected concomitant disease(s) that could affect study-specific assessments and/or their evaluation, or might compromise patients' safety and/or compliance (e.g. organic diseases or infections of the gastrointestinal tract (with exceptions), certain malignancies or cancers, certain metabolic disorders) Regular oral treatment with more than 2.4 g/d mesalazine (or therapeutic equivalent, i.e., either > 2.4 g/d olsalazine, > 5.6 g/d balsalazide, or > 6.2 g/d sulfasalazine) within the last 4 weeks prior to baseline, Regular rectal treatment with more than 0.5 g/d mesalazine, olsalazine or more than 1 g/d sulfasalazine within the last 4 weeks prior to baseline, Oral/rectal/intravenous corticosteroids therapy within the last 4 weeks priorto screening endoscopy, For Germany only: diagnosis of active COVID-19
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove the superiority of combined treatment of oral mesalazine and novel budesonide suppositories vs. oral mesalazine monotherapy in regard to early response after 4 weeks of treatment in patients with acute ulcerative colitis (UC).;Secondary Objective: - To assess the efficacy in terms of relief of clinical signs and symptoms and relief of mucosal inflammation after 8-weeks of combined treatment of oral mesalazine and novel budesonide suppositories vs. oral mesalazine monotherapy in patients with UC, - To assess safety and tolerability in the form of adverse events and laboratory parameters, - To assess patients’ acceptance of the investigational medicinal products, - To assess patients’ quality of life.;Primary end point(s): Co-primary efficacy endpoints: - Proportion of patients with clinical remission - Proportion of patients with endoscopic remission;Timepoint(s) of evaluation of this end point: after 4 weeks of treatment (both endpoints) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients with clinical remission 2. Proportion of patients with endoscopic remission 3. Proportion of patients with clinical remission and endoscopic remission 4. Proportion of patients with clinical remission 5. Proportion of patients with clinical remission and endoscopic remission 6. Time to resolution of clinical symptoms;Timepoint(s) of evaluation of this end point: Secondary endpoints 1. and 2.: end of treatment (week 8) or withdrwal visit Secondary endpoints 3. - 5.: after 4 weeks of treatment Secondary endpoint 6.: first day of disease resolution of three consecutive days | — |
Countries
Belarus, Bulgaria, Germany, Latvia, Poland, Russian Federation, Ukraine
Contacts
Public ContactDept. of Clinical R&D
Dr. Falk Pharma GmbH
Outcome results
None listed