The purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.
Ulcerative colitis is a disease that causes inflammation of the large bowel, causing fever, diarrhoea, dehydration and other symptoms. Standard treatment for ulcerative colitis includes general medical treatments such as fluid and salt replacement and attention to diet. Anti-inflammatory medicines such as steroids (e.g. prednisolone) and aminosalicylates (e.g. mesalazine) are the main drug treatments. This study will investigate whether COLAL-PRED®, a novel dosage form of a prednisolone ester, is safe and effective in the treatment of ulcerative colitis, compared with the standard treatment (conventional prednisolone) and also to determine which dose which will work best for future patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
796
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
Disease activity index
Time frame: After 4 and 8 weeks of treatment
Cortisol levels
Time frame: After 4 and 8 weeks of treatment
Simple clinical colitis activity index
Time frame: 8 weeks
Endoscopy
Time frame: 8 weeks
Adverse events
Time frame: 12 weeks
Laboratory tests
Time frame: 12 weeks
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Bankstown, New South Wales, Australia
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Bedford Park, South Australia, Australia
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Parkville, Victoria, Australia
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Brussels, Belgium
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Ghent, Belgium
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Roeselare, Belgium
Gastroenterologicka ambulance
Hradec Králové, Czechia
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové, Czechia
Krajska nemocnice Liberec
Liberec, Czechia
Research Site
Olomouc, Czechia
...and 76 more locations