Colitis, Ulcerative Clinical Trial
Official title:
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of COLAL-PRED in the Treatment of Patients With Moderate to Severe Ulcerative Colitis
The purpose of this study is to determine whether COLAL-PRED is a safe and effective treatment for patients with moderate to severe ulcerative colitis.
This is a multi-center, randomized, double-blind, placebo-controlled, parallel-design,
dose-ranging study. Eligible patients with a DAI score of 6 to 10 (inclusive), plus
endoscopic evidence of moderate to severe ulcerative colitis as assessed by flexible
sigmoidoscopy, unless colonoscopy is clinically indicated, and rectal bleeding will be
randomized to placebo or one of four doses of COLAL-PRED (equivalent to 40, 60, 80, or 120 mg
of prednisolone). The effectiveness and safety of COLAL-PRED will be evaluated at baseline,
and after 2 weeks and 4 weeks of treatment. Additional follow-up measurements will take place
7 days post cessation of treatment.
The systemic absorption of COLAL-PRED will be determined by measuring blood levels of
prednisolone, prednisolone sodium metasulfobenzoate (PMSBS) and metasulfobenzoate at Week 4.
Hypothalamic-pituitary-adrenocortical (HPA) axis response will be monitored by measuring
morning serum cortisol levels at Baseline, Week 2, Week 4, and at follow-up visit and
cortisol levels following adrenocorticotrophic hormone (ACTH) stimulation testing at Baseline
and Week 4.
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