Therapy of active ulcerative colitis MedDRA version: 7.1 Level: LLT Classification code 10058816
Conditions
Interventions
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
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion 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
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 = 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania
Outcome results
None listed