K51.0
Conditions
Interventions
Group 1: budesonide enama 2 mg/100 ml over 8 weeks
Group 2: Mesalazine Clysma 4g/60 ml over 8 weeks
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Active left sided colitis ulcerosa Diagnosis confirmed by endoscopy or histology History of at least one acute attack Maximal extent of disease tot he sinistrial flexure Clinical activity score => 4 Endoscopy score => 2 Negative stool culture Aged 18 years or older Written consent to participation in the study
Exclusion criteria
Exclusion criteria: Infectious origin of colitis Preceding treatments: - Glucocorticoids (oral, parenteral, or rectal) within the two weeks preceding inclusion, exempt contraceptivs, estrogenic hormons, eye-drops and ointmets/creams containing prednisolone derivativs, - Immune suppressive drugs (azathioprine, 6-mercaptopurine, Methotrexate, Cyclosporine) within the preceding 6 months, - 5-amonosalicyclic acid (5-ASA), sulphasalazine, or olsalazine in variable dosage within the preceding 2 weeks - NSAIDs for more than 3 consecutive days - Antibiotics during the preceding 2 weeks other that following a defined infection for less than 10 days - Anticoagulants - Oral antidiabetic medicaton or sulfonic carbamide type, - Spironolactone, furosemide - Probenicide, sulfinpyrazone - Rifampicin Active immunization against virus or bacteria within the preceding 3 months Pregnancy, planned pregnancy, lactation period, Clinical significant hepatic, nephritic, or cardiovascular concomitant disease that could influence resorption, metabolism or excretion of test medication Known intolerance to salycilate or budesonide, Participation in other therapeutical trials within the preceding month, Previous randomisation within this study, Alcohol or drug dependency, Expected lack of compliance with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the tolerability of rectal injections of Budesonide and Mesalazine, measured in terms of number of patients affected by adverse events and number of withdrawls from study treatmant | — |
Secondary
| Measure | Time frame |
|---|---|
| Rates of clinical remission after 4 weeks and endoscopic remission after 8 weeks of treatmant. Clinical remission was defined in terms of a clinical activity index (remission: index < 4) Endoscopic remission was defined in terms of an endoscopic score (remission: endoscopic score < 2) | — |
Countries
Germany
Contacts
Public ContactFranz Hartmann
Lehrkrankenhaus
Outcome results
None listed