← Back to Search

Corticosteroid

Hydrocortisone Suppositories for Ulcerative Proctitis

Phase 3
Waitlist Available
Research Sponsored by Cristcot LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you more than 5 foot 9 inches tall?
Do you weigh more than 180 pounds?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 20 Other Conditions

Summary

This trial is testing a new way to deliver a medication for ulcerative colitis via a suppository. The study will compare the safety and effectiveness of two different doses given with a new applicator.

Who is the study for?
Adults over 18 with active ulcerative colitis of the rectum, not extending beyond 15 cm from the anal verge. Participants must have certain symptom scores, be taller than 5'9", weigh over 180 pounds, and be willing to undergo a colonoscopy. Excluded are those with infectious colitis, recent GI surgery (except some), bleeding hemorrhoids, or other specific GI conditions.
What is being tested?
The trial is testing two dosing regimens of hydrocortisone acetate suppositories (90 mg) using a Sephure applicator: one group will use it once daily and another twice daily against a placebo group. The study aims to determine which regimen is safer and more effective for treating ulcerative proctitis.
What are the potential side effects?
Potential side effects may include local irritation or inflammation at the application site, increased risk of infection due to immune suppression by hydrocortisone, mood swings, elevated blood pressure, blood sugar imbalances, and possible adrenal insufficiency with long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am taller than 5 foot 9 inches.
Select...
My ulcerative colitis symptoms are currently flaring up.
Select...
I am willing to undergo a colonoscopy for the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical remission measured using the Modified Mayo Score
Secondary study objectives
Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0
Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency
Other study objectives
Concentrations of hydrocortisone acetate using pharmacokinetic sampling
Grading of disease severity measure using Mayo Scoring sub-score of Physician's Global Assessment
Quality of Life assessed measured using IBDQ validated questionnaire

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Twice Daily - ActiveExperimental Treatment1 Intervention
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator
Group II: Once Daily - ActiveExperimental Treatment1 Intervention
Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator
Group III: PlaceboPlacebo Group1 Intervention
Twice daily placebo suppository administered with Sephure suppository applicator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
2020
Completed Phase 3
~200
Hydrocortisone acetate
FDA approved

Find a Location

Who is running the clinical trial?

Cristcot LLCLead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
Cristcot HCA LLCIndustry Sponsor
Jennifer DavagianStudy DirectorCristcot LLC
Ade Adeboye, MDStudy DirectorCristcot LLC
Karthik Devarajan, MDStudy DirectorCristcot LLC

Media Library

Hydrocortisone Acetate Suppositories (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04469686 — Phase 3
Ulcerative Proctitis Research Study Groups: Placebo, Once Daily - Active, Twice Daily - Active
Ulcerative Proctitis Clinical Trial 2023: Hydrocortisone Acetate Suppositories Highlights & Side Effects. Trial Name: NCT04469686 — Phase 3
Hydrocortisone Acetate Suppositories (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04469686 — Phase 3
~40 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top