A randomized, multi-center, double-blind, three arm placebo-controlled study in male and non-pregnant, non-lactating female subjects aged 18 years to examine the safety and efficacy of two dosing regimens of hydrocortisone acetate 90 mg suppository administered with the Sephure applicator for the treatment of ulcerative colitis of the rectum.
Hydrocortisone acetate 90 mg or placebo will be administered as a rectal suppository with a Sephure suppository applicator. Two arms of the study will receive different dosage regimens of hydrocortisone acetate, and the third arm will receive placebo. All subjects will administer the study drug twice a day; once in the morning and once in the evening for 28 days. The study population will consist of male and non pregnant, non lactating females aged 18 years and older with a confirmed diagnosis of active UC of the rectum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
Clinical remission measured using the Modified Mayo Score
To evaluate the the efficacy of two dosage regimens of the study drug
Time frame: 28 days
Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency
To assess the change in stool frequency
Time frame: 28 days
Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0
To assess the change in rectal bleeding
Time frame: 28 days
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Twice daily placebo suppository administered with Sephure applicator
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