Ulcerative Colitis
Conditions
Brief summary
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
Interventions
DRUGmesalazine
Sponsors
Dr. Falk Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
(main): * Active ulcerative colitis except proctitis, i.e. inflammation minimal 15cm 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
Exclusion criteria
(main): * Crohn's disease * Toxic megacolon * Present or past colorectal cancer * Symptomatic gastrointestinal disease * Serious secondary disease(s) * Baseline stool positive for germs causing bowel disease * Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline * Current relapse occurred under maintenance treatment with \>2g/day mesalazine * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of clinical remission | — |
Secondary
| Measure | Time frame |
|---|---|
| time to resolution of symptoms | — |
| rate of endoscopical remission | — |
| rate of endoscopical response | — |
| Rate of clinical response | — |
| rate of histological response | — |
| PGA | — |
| rate of histological remission | — |
Countries
Germany
Outcome results
None listed