To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
274
Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.
Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score
UCDAI is a four-component scale, used to determine the severity of ulcerative colitis. The four components assessed are stool frequency, rectal bleeding, mucosal appearance and physician's rating of disease activity. Score for each component can range between 0-3 and thus, the maximum overall score can be between 0-12. Higher score implies higher disease severity.
Time frame: After 8 weeks
Percentage of subjects achieving clinical remission after 8 weeks of treatment
Time frame: 8 weeks
Percentage of subjects achieving 0 score for subscores of rectal bleeding, stool frequency and mucosal appearance (normal mucosa) in UCDAI after 8 weeks of treatment
Time frame: 8 weeks
Percentage of subjects achieving clinical improvement after 8 weeks of treatment
Time frame: 8 weeks
Percentage of subjects achieving endoscopic improvement after 8 weeks of treatment for subjects with baseline UCDAI mucosal appearance subscore greater than equal to [≥]1
Time frame: 8 weeks
Percentage of subjects achieving symptom resolution after 2 weeks of treatment
Time frame: 2 weeks
Percentage of subjects achieving symptom resolution after 4 weeks of treatment
Time frame: 4 weeks
Percentage of subjects achieving symptom resolution after 8 weeks of treatment
Time frame: 8 weeks
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Ferring Investigator Site JPN27
Nagoya, Aichi-ken, Japan
Ferring Investigator Site JPN52
Toyoake-shi, Aichi-ken, Japan
Ferring Investigator Site JPN47
Toyota-shi, Aichi-ken, Japan
Ferring Investigator Site JPN69
Abiko-shi, Chiba, Japan
Ferring Investigator Site JPN68
Kashiwa-shi, Chiba, Japan
Ferring Investigator Site JPN53
Urayasu-shi, Chiba, Japan
Ferring Investigator Site JPN08
Matsuyama, Ehime, Japan
Ferring Investigator Site JPN50
Fukui-shi, Fukui, Japan
Ferring Investigator Site JPN51
Chikushino-shi, Fukuoka, Japan
Ferring Investigator Site JPN31
Fukuoka, Fukuoka, Japan
...and 62 more locations
Percentage of subjects with endoscopic healing after 8 weeks of treatment
Time frame: 8 weeks
Change from baseline in partial UCDAI score at 2 weeks
Time frame: 2 weeks
Change from baseline in partial UCDAI score at 4 weeks
Time frame: 4 weeks
Change from baseline in partial UCDAI score at 8 weeks
Time frame: 8 weeks