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

• Register: EUCTR
• Last refreshed on: 26 November 2018
• Main ID: EUCTR2012-001830-32-HU
• Date of registration: 16/08/2012
• Prospective Registration: Yes
• Primary sponsor: Dr. Falk Pharma GmbH
• Public title: 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
• Scientific title: Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical 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 - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC
• Date of first enrolment: 04/10/2012
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001830-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: double-dummy; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Hungary, Latvia, Lithuania, Poland, Russian Federation, Ukraine

Contacts

• Name: Project Manager
• Affiliation: Dr. Falk Pharma GmbH

• Name: Project Manager
• Affiliation: Dr. Falk Pharma GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
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,


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Active ulcerative colitis
MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: Mesalazine 1000 mg gastro-resistant tablets
Product Code: Mesalazine 1000 mg gastro-resistant tablets
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3000-
Pharmaceutical form of the placebo: Gastro-resistant tablet
Route of administration of the placebo: Oral use

Trade Name: Salofalk® 500 mg gastro-resistant tablet
Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg)
Product Code: Salofalk® 500 mg tablets
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3000-
Pharmaceutical form of the placebo: Gastro-resistant tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: - To study safety and tolerability
- To assess patients' acceptance and preference of trial drugs
- To assess patients' quality of life

Primary end point(s): Rate of clinical remission after 8 weeks

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

Timepoint(s) of evaluation of this end point: After 8 weeks of treatment

Secondary Outcome(s)

Secondary end point(s): Rate of clinical improvement (CAI)
Number of stools per week
Number of bloody stools per week
Number of days with urgency per week
Time to first resolution of clinical symptoms
Patient’s Quality of Life
Patient’s Global Satisfaction
Patient’s acceptance and preference of trial drug
Physician's Global Assessment
Adverse Events (AEs)
Vital signs (blood pressure, heart rate) and body weight
Laboratory assessments

Timepoint(s) of evaluation of this end point: Each visit, if not otherwise defined

Secondary ID(s)

SAT-25/UCA

Source(s) of Monetary Support

Dr. Falk Pharma GmbH