A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis
- Conditions
- Active ulcerative colitisMedDRA version: 16.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-001830-32-PL
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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,
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1.Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis),
2.Toxic megacolon,
3.Screening stool positive for germs causing bowel disease,
4.Malabsorption syndromes,
5.Celiac disease,
6.Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhoea or gastrointestinal bleeding,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the trial is to proof the non-inferiority of an 8-week treatment with three times daily 1000mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis;Secondary Objective: - To study safety and tolerability<br>- To assess patients' acceptance and preference of trial drugs<br>- To assess patients' quality of life;Primary end point(s): Rate of clinical remission after 8 weeks;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 (CAI) <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>Patient’s Quality of Life<br>Patient’s Global Satisfaction<br>Patient’s acceptance and preference of trial drug <br>Physician's Global Assessment<br>Adverse Events (AEs)<br>Vital signs (blood pressure, heart rate) and body weight<br>Laboratory assessments<br>;Timepoint(s) of evaluation of this end point: Each visit, if not otherwise defined