Efficacy and Safety of new oral Budesonide-MMX 6 mg and 9 mg extended release tablet formulations in patients with mild or moderate, active Ulcerative Colitis. A multicenter, randomized, double-blind, double dummy comparative study versus Placebo, with an additional reference arm evaluating AsacolÂ® 2400 mg.

COSMO Technologies Ltd0 sites510 target enrollmentStarted: TBDLast updated: November 24, 2021

Trial Snapshot

No summary available.

•Adult males or females aged between 18 and 75 years of age, suffering from mild or moderate, active Ulcerative colitis for at least 6 months.
•Diagnosis of Ulcerative colitis with Ulcerative Colitis Disease Activity Index (UCDAI)more than or equal to 4 and less than or equal to 10.
•All females of child-bearing potential must have a negative serum pregnancy test immediately prior to enrollment and also throughout the entire study period.

•Patients with limited distal proctitis, severe ulcerative colitis (UCDAI > 10), infectious colitis, evidence or history of toxic megacolon, severe anemia, leucopenia or granulocytopenia, intolerance to salicylates, liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoral parameters.
•Patients diagnosed with type 1 diabetes, glaucoma, Hepatitis B, Hepatitis C, HIV.
•Use of oral or rectal steroids in the last 4 weeks, use of immuno-suppressive agents in the last 8 weeks before the study, use of anti-TNF alpha agents in the last 3 months.
•Concomitant use of any rectal preparation, antibiotics, CYP3A4 inducers or inhibitors.

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