Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator for Ulcerative Proctitis
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.
- Ulcerative Proctitis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 28 days
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Once Daily - Active
1 of 3
Twice Daily - Active
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group
618 Total Participants · 3 Treatment Groups
Primary Treatment: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 35.8% |
| Georgia | 11.3% |
| New York | 11.3% |
| Other | 41.5% |
How old are they?
| 18 - 65 | 64.0% |
| 65+ | 34.0% |
| < 18 | 2.0% |
What site did they apply to?
| Ohio Gastroenterology & Liver Institute | 14.3% |
| Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J. | 28.6% |
| Dr. Jignesh P. Shah | 14.3% |
| Other | 42.9% |
What portion of applicants met pre-screening criteria?
| Met criteria | 33.3% |
| Did not meet criteria | 66.7% |
How responsive is this trial?
Average response time
- < 1 Day
Most responsive sites:
- One Health Research Clinic Atlanta: < 24 hours
Typically responds via
| Phone Call | 100.0% |
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor