Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-001216-31-LT
• Date of registration: 28/04/2005
• Prospective Registration: Yes
• Primary sponsor: Dr. Falk Pharma GmbH
• Public title: Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC
• Scientific title: Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC
• Date of first enrolment: 06/06/2005
• Target sample size: 320
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001216-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: double-dummy If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: different dosage scheme

Countries of recruitment

Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania

Key inclusion & exclusion criteria

Inclusion criteria:
- Signed informed consent
- Men or women aged 18 to 75 years
- Active ulcerative colitis except proctitis, i.e. inflammation minimal 15 cm ab ano, confirmed by endoscopy and histology
- Established or new diagnosis
- Disease activity at baseline:
Clinical Activity Index (CAI) > 4 and Endoscopic Index (EI) >=4
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:
- Crohn's disease,
- Prior bowel resection leading to diarrhoea and/or pouch formation,
- Toxic megacolon,
- Gastric or duodenal ulcer,
- Haemorrhagic diathesis,
- Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding haemorrhoids or hiatal hernia),
- Active colorectal cancer or a history of colorectal cancer,
- Serious other secondary illnesses of an acute or chronic nature,
- Asthma,
- Serum creatinine >= 1.2x upper limit of normal (ULN) and creatinine clearance < 60 ml/min per 1.73 m2,
- Serum transaminase (ALT and/or AST) and/or alkaline phosphatase >= 2x ULN,
- Baseline stool positive for germs causing bowel disease,
- Current relapse occurred under maintenance treatment with > 2.0 g/day mesalazine or > 3.0 g/day sulfasalazine,
- Application of immunosuppressants within 3 months and/or corticosteroids (oral, intravenous [IV] or topical rectal) within 30 days prior to baseline,
- Application of non-steroidal anti-inflammatory drugs (NSAIDs) as long term treatment; permitted is acetylsalicylic acid (<= 350 mg/day) and paracetamol,
- Known intolerance/hypersensitivity to salicylic acid and its derivatives or to any of the other constituents of the study drugs,
- Well-founded doubt about the patient’s cooperation,
- Existing or intended pregnancy, breast-feeding,
- Women of child-bearing potential without adequate contraceptive protection, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. The investigator is responsible for determining whether the subject has adequate birth control for study participation,
- Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial



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

Health Condition(s) or Problem(s) studied

Therapy of active ulcerative colitis
MedDRA version: 7.1 Level: LLT Classification code 10058816

Intervention(s)

Trade Name: Salofalk® 1000mg Granu-Stix®
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: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Gastro-resistant granules
Route of administration of the placebo: Oral use

Product Name: 1500mg mesalazine pellets
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: equal
Concentration number: 1500-

Product Name: 500mg mesalazine pellets
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: equal
Concentration number: 500-

Primary Outcome(s)

Main Objective: To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active 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

Primary end point(s): Rate of clinical remission (defined by CAI <= 4) at the final/withdrawal visit

Secondary ID(s)

2004-001216-31-DE

not available

SAG-26/UCA