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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001830-32-HU

Enrollment

400

Registered

2012-08-16

Start date

2012-10-04

Completion date

Unknown

Last updated

2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 Num

Eligibility

Sex/Gender

All

Inclusion 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

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,

Design outcomes

Primary

Measure	Time frame
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 - 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;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

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

Contacts

Public ContactProject Manager

Dr. Falk Pharma GmbH

nacak@drfalkpharma.de00497611514187

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026