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 suppository 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 ulcerative colitis 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
The primary efficacy endpoint was specified as the between-treatment group (HCA Suppository 90 mg bid versus placebo and HCA Suppository 90 mg qd versus placebo) difference in the proportion of subjects with clinical remission at the End of Treatment visit (Day 29). Clinical remission was defined as a Modified Mayo Total Score of 0 to 2, with stool frequency subscore of 0 or 1 (minimum 1 point decrease from baseline), rectal bleeding subscore of 0, and endoscopic subscore of 0 or 1.
Time frame: 29 days
Reduction of Stool Frequency
Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency to assess the change in stool frequency from Baseline (Day 1) to End of Treatment (Day 29) and from Baseline (Day 1) to Follow-up (Day 15).
Time frame: 29 days
Rectal Bleeding
Rectal Bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to assess the change in rectal bleeding in active treatment groups vs. placebo group from Baseline (Day 1) to End of Treatment (Day 29) and from Baseline (Day 1) to Follow-up (Day 15).
Time frame: 29 days
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Twice daily placebo suppository administered with Sephure applicator
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