Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001218-15-DE

Enrollment

510

Registered

2004-12-10

Start date

2005-04-04

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Maintenance therapy of ulcerative colitis

Interventions

Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Other descriptive name: 5-Aminosalicylic acid Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed informed consent - Men or women aged 18 to 75 years - Historically confirmed diagnosis of ulcerative colitis by endoscopy and histology - Patient being in remission, defined as: Clinical Activity Index (CAI) = 15 cm beyond the anal margin - Last acute episode ended within 3 months prior to study entry 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Crohn’s disease - Prior bowel resection leading to diarrhoea and/or pouch formation - Toxic megacolon - Gastric or duodenal ulcer - Haemorrhagic diathesis - Present or past colorectal cancer - Symptomatic gastrointestinal disease - Serious secondary disease(s) - Asthma - Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline - Serum creatinine >= 1.2x upper limit of normal (ULN) and creatinine clearance = 2x ULN - Known intolerance/hypersensitivity to salicylic acid and its derivatives or to any of the other constituents of the study drugs

Design outcomes

Primary

Measure	Time frame
Primary end point(s): clinical remission at the final/withdrawal visit, with clinical relapse being defined as CAI > 4 and an increase of >= 3 points from baseline;Main Objective: To proof the therapeutic equivalence of once daily (OD) versus tree times daily (TID) dosing of total 1.5 g mesalazine for remission maintenance and to evaluate whether 3 g OD is superior to 0.5 g TID mesalazine for remission maintenance in patients with ulcerative colitis;Secondary Objective: - To study safety and tolerability in the form of adverse events and laboratory parameters (including renal safety parameters) - To assess patients' preference regarding dosing schedule - To assess patients' quality of life	—

Measure

Time frame

Primary end point(s): clinical remission at the final/withdrawal visit, with clinical relapse being defined as CAI > 4 and an increase of >= 3 points from baseline;Main Objective: To proof the therapeutic equivalence of once daily (OD) versus tree times daily (TID) dosing of total 1.5 g mesalazine for remission maintenance and to evaluate whether 3 g OD is superior to 0.5 g TID mesalazine for remission maintenance in patients with ulcerative colitis;Secondary Objective: - To study safety and tolerability in the form of adverse events and laboratory parameters (including renal safety parameters) - To assess patients' preference regarding dosing schedule - To assess patients' quality of life

—

Countries

Estonia, Germany, Hungary, Latvia, Lithuania

Outcome results

None listed

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