Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis
- Conditions
- Patients with active ulcerative colitisMedDRA version: 18.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2014-005635-14-HU
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1.Signed informed consent,
2.Men or women aged 18 to 75 years,
3.Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
4. Established diagnosis of UC, based on clinical history, exclusion of infectious
causes, and characteristic endoscopic and histologic findings,
5. Clinical Activity Index (CAI) > 4 and = 12 and Endoscopic Index (EI) = 4,
6. Insufficient response or intolerance to a previous or current treatment with
mesalazine -containing or -releasing drugs,
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 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
1.Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis,
2.Toxic megacolon or fulminant colitis,
3.Colon resection,
4.Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),
5.Malabsorption syndromes,
6.Celiac disease,
7.Bleeding hemorrhoids,
8.Active peptic ulcer disease
9.Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
10.Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma,
cataract, psychiatric disorders or infection if careful medical monitoring is not
ensured,
11.Any severe infectious disease (e.g., tuberculosis, AIDS),
12.Severe co-morbidity substantially reducing life expectancy,
13.History of colorectal cancer,
14.History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate the efficacy of a 8-week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis.<br>;Secondary Objective: Secondary objectives are to study safety and tolerability in the form of adverse events and laboratory parameters.<br>;Primary end point(s): Rate of clinical remission at final/withdrawal visit;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 clinical improvement at final/withdrawal visit<br>•Number of stools per week<br>•Number of bloody stools per week<br>•Number of days with urgency per week<br>•Time to first resolution of clinical symptoms<br>•Rate of endoscopic remission/improvement at final/withdrawal visit<br>•Rate of histological remission/improvement at final/withdrawal visit<br>•Course of faecal calprotectin<br>;Timepoint(s) of evaluation of this end point: Each visit, if not otherwise defined.