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Corticosteroid

Hydrocortisone Suppositories for Ulcerative Proctitis

Phase 3
Recruiting
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

Study 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.Check my eligibility
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.See study design
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
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I am taller than 5 foot 9 inches.
Select...
My ulcerative colitis symptoms are currently flaring up.
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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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical remission measured using the Modified Mayo Score
Secondary outcome measures
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 outcome measures
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

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

Find a Location

Who is running the clinical trial?

Cristcot LLCLead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
Cristcot HCA LLCIndustry Sponsor
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are involved in this research project?

"In order to run this trial, 618 individuals who satisfy the set criteria must enroll. Two locations where participants can join this trial are Aspira International in Pasadena, Texas and Southern Star Research Institute in San Antonio, Michigan."

Answered by AI

What maladies does Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator help ameliorate?

"Twice daily administration of 90 mg hydrocortisone acetate suppository using a Sephure applicator can help reduce the symptoms of pruritus ani, skin irritation, and dermatitis infected."

Answered by AI

Could you inform me as to how many different locations this trial is being conducted?

"Presently, this study is looking for 22 more patients. There are many locations still recruiting, including Aspira International in Pasadena, Southern Star Research Institute in San Antonio, and Clinical Research Institute of Michigan in Chesterfield."

Answered by AI

Is the FDA's stamp of approval on Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator?

"There is some evidence for the efficacy of Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator, as this is a Phase 3 trial. Furthermore, multiple rounds of data support its safety, so it received a score of 3."

Answered by AI

Can patients currently join this trial?

"Yes, the information on clinicaltrials.gov reveals that this trial is still recruiting patients. The trial was first posted on December 10th 2020 and was last updated on August 17th 2022. So far, the trial has recruited 618 patients from 22 different locations."

Answered by AI

Have there been other scientific studies involving a Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator?

"Currently, there are 5 Phase 3 trials and 1 additional study for Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator. Although a few of the research sites are located in New Brunswick, New jersey, there are a total of 882 clinical trial sites across the globe testing this medication."

Answered by AI

Who else is applying?

What state do they live in?
New York
Florida
Texas
Other
How old are they?
< 18
65+
18 - 65
What site did they apply to?
Ohio Gastroenterology & Liver Institute
Dr. Jignesh P. Shah
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. One Health Research Clinic Atlanta: < 24 hours
  2. Homestead Associates in Research: < 48 hours
Typically responds via
Phone Call
~15 spots leftby Apr 2024