Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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 Applicator in Subjects With Ulcerative Colitis

Conditions
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Ulcerative Proctitis

Intervention / Treatment
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* Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
* Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
* Combination Product: Twice daily placebo suppository administered with Sephure applicator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non pregnant, non lactating females aged 18 years and older. Subjects with a confirmed diagnosis of active UC of the rectum, extending no more than 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy performed at Visit 2. Note: Subjects may have a history of more extensive UC (e.g., pancolitis), but have active disease only in the rectum at the time of enrollment. Modified Mayo sub score for stool frequency of 1 3. Modified Mayo sub score for rectal bleeding of 0 2. Modified Mayo endoscopic sub score of 2 3. Total Modified Mayo Score (without physician global assessment) of 4-8. Exclusion Criteria: History or current diagnosis of bacterial or other infectious colitis, radiation enteritis and radiation proctitis, Crohn's disease, collagenous colitis and indeterminate colitis. Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia. Concomitant active lower gastrointestinal disease (except Irritable Bowel Syndrome) or distortion of intestinal anatomy. Bleeding hemorrhoids at the time of enrollment. Acute diverticulitis at the time of enrollment. Acute or chronic pancreatitis at the time of enrollment. Unmanaged celiac disease at the time of enrollment. Positive stool test for enteric pathogens, Clostridium difficile, or presence of ova and parasites. Taking a prohibited medication.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Twice Daily - Active<br>Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator | Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator<br>* Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator<br>* Other names: Twice Daily - Active;|
| Experimental: Once Daily - Active<br>Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator | Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator<br>* Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator<br>* Other names: Once Daily - Active;|
| Placebo Comparator: Placebo<br>Twice daily placebo suppository administered with Sephure suppository applicator | Combination Product: Twice daily placebo suppository administered with Sephure applicator<br>* Twice daily placebo suppository administered with Sephure applicator<br>* Other names: Twice Daily - Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission measured using the Modified Mayo Score | To evaluate the the efficacy of two dosage regimens of the study drug | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency | To assess the change in stool frequency | 28 days | 
| Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0 | To assess the change in rectal bleeding | 28 days |