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 个研究点目标入组 510 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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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