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Hydrocortisone Suppositories 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have bleeding hemorrhoids currently.I do not have active lower GI diseases other than IBS or changes in my intestinal structure.I have or had a serious bowel condition like Crohn's disease or colitis.I have had gastrointestinal surgery, but not for appendix, gallbladder, or hernia issues.I am taller than 5 foot 9 inches.I am not taking any medication that is not allowed in the study.Do you weigh more than 180 pounds?My ulcerative colitis symptoms are currently flaring up.I am willing to undergo a colonoscopy for the trial.I have celiac disease that is not currently under control.
- Group 1: Placebo
- Group 2: Once Daily - Active
- Group 3: Twice Daily - Active
- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- One Health Research Clinic Atlanta: < 24 hours
- Homestead Associates in Research: < 48 hours
Typically responds via
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