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

Phase 3

Completed

• Conditions: Ulcerative Proctitis
• Interventions: Combination Product: Twice daily placebo suppository administered with Sephure applicator; 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

• Registration Number: NCT04469686
• Lead Sponsor: Cristcot LLC

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.

Study Timeline

• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-14
• Study Start: 2020-12-10
• Primary Completion: 2024-07-16
• Study Completion: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 618

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Twice daily placebo suppository administered with Sephure applicator	Twice daily placebo suppository administered with Sephure suppository applicator
Twice Daily - Active	Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator	Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator
Once Daily - Active	Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator	Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator

Primary Outcome Measures

Name	Time	Method
Clinical remission measured using the Modified Mayo Score	28 days	To evaluate the the efficacy of two dosage regimens of the study drug

Secondary Outcome Measures

Name	Time	Method
Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0	28 days	To assess the change in rectal bleeding
Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency	28 days	To assess the change in stool frequency

Trial Locations

Locations (1)

Gastro Health Research; 🇺🇸 Cincinnati, Ohio, United States