Clinical study to investigate the efficacy and safety of a budesonide suppository for the treatment of acute ulcerative proctitis
- Conditions
- Acute ulcerative proctitisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-003362-41-DE
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 337
- 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 < modified UC-DAI < 11) with endoscopic subscore of = 1
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 256
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>;Secondary Objective: - To evaluate other clinical efficacy endpoints of a treatment of novel budesonide suppository in patients with acute ulcerative proctitis<br><br>- To assess safety and tolerability in the form of adverse events and laboratory parameters<br><br>- To assess patients' acceptance of the investigational medicinal product<br>;Primary end point(s): Time to resolution of clinical symptoms ;Timepoint(s) of evaluation of this end point: Evaluated at the final/withdrawal visit<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Rate of clinical and endoscopic remission<br> <br>- Rate of improvement<br><br>- Time to resolution of the hallmark symptoms of UC <br><br>- Rate of patients with mucosal healing <br><br>;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<br><br>