Clinical trial NCT04469686: Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Proctitis
Lead sponsor: Cristcot LLC
Sponsor class: INDUSTRY
Collaborators: name: Cristcot HCA LLC
First posted: 2020-07-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical remission measured using the Modified Mayo Score
timeFrame: 28 days
Secondary outcomes:
measure: Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency
timeFrame: 28 days
measure: Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0
timeFrame: 28 days
Other outcomes:
measure: Quality of Life assessed measured using IBDQ validated questionnaire
timeFrame: 28 days
measure: Grading of disease severity measure using Mayo Scoring sub-score of Physician's Global Assessment
timeFrame: 28 days
measure: Concentrations of hydrocortisone acetate using pharmacokinetic sampling
timeFrame: 28 days
Locations:
city: Cincinnati
country: United States
facility: Gastro Health Research
state: Ohio
Study officials:
affiliation: Cristcot LLC
name: Jennifer Davagian
role: STUDY_DIRECTOR
References: