3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Suppository Applicator in Subjects With Ulcerative Colitis of the Rectum
3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Suppository Applicator in Subjects With Ulcerative Colitis of the Rectum
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.
Inclusion Criteria:
Exclusion Criteria:
Los Angeles, California 90045, United States
Tbilisi, 144, Georgia
Mumbai, Maharashtra 400022, India
Monserrato, Cagliari 09042, Italy
Chisinau, MD 2025, Moldova
Szczecin, West Pomeranian Voivodeship 71-434, Poland
Bydgoszcz, 85-794, Poland
Cluj-Napoca, 400394, Romania
Ryazan, 390039, Russia
Saint Petersburg, 191015, Russia
Saint Petersburg, 191015, Russia
Saint Petersburg, 199226, Russia
Madrid, Madrid 28040, Spain
Istanbul, 34899, Turkey (Türkiye)
Trabzon, 61080, Turkey (Türkiye)
Kharkiv, 61037, Ukraine
Kyiv, 01030, Ukraine
Lviv, 79010, Ukraine
Odesa, 65025, Ukraine
Vinnytsia, 21028, Ukraine
Vinnytsia, 21029, Ukraine