Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories
Public ClinicalTrials.gov record NCT04469686. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Suppository Applicator in Subjects With Ulcerative Colitis of the Rectum
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 suppository applicator for the treatment of ulcerative colitis of the rectum.
Study identification
- NCT ID
- NCT04469686
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
- 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 Combination Product
- Twice daily placebo suppository administered with Sephure applicator Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 10, 2020 (Actual)
- Primary completion
- Sep 19, 2024 (Actual)
- Completion
- Sep 19, 2024 (Actual)
- Last update posted
- Aug 6, 2026
2020 – 2024
United States locations
- U.S. sites
- 51
- U.S. states
- 17
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Associates LLC | Huntsville | Alabama | 35801 | — |
| Om Research | Apple Valley | California | 92307 | — |
| Om Research | Camarillo | California | 93012 | — |
| Precision Research | El Cajon | California | 92020 | — |
| Om Research | Lancaster | California | 93534 | — |
| Southern CA Research Institute Medical Group/W Gastroenterology Medical Group | Los Angeles | California | 90045 | — |
| Cornell Medical Research | Newport Beach | California | 92663 | — |
| California Medical Research Associates Inc | Northridge | California | 91324 | — |
| Clinical Applications Laboratories Inc | San Diego | California | 92103 | — |
| I.H.S. Health, LLC | Kissimmee | Florida | 34741 | — |
| Homestead Associates in Research | Miami | Florida | 33032 | — |
| Rejuvaline Medical Research | Miami | Florida | 33155 | — |
| Ezy Medical Research, Co. | Miami | Florida | 33175 | — |
| US Associates In Research | Miami | Florida | 33175 | — |
| Gastro Health Research of Miami | Miami | Florida | 33176 | — |
| GI PROS Research | Naples | Florida | 34102 | — |
| Gastroenterology of Greater Orlando | Orange City | Florida | 32763 | — |
| Revival Clinical Research | Orlando | Florida | 32807 | — |
| BRCR Global Clinical Research | Plantation | Florida | 33322 | — |
| International Center for Research | Tampa | Florida | 33614 | — |
| One Health Research Clinic Atlanta | Johns Creek | Georgia | 30097 | — |
| Comprehensive Gastrointestinal Health, LLC | Northbrook | Illinois | 60062 | — |
| Cedar Valley Medical Specialists, P.C. | Waterloo | Iowa | 50701 | — |
| Combined Gastro LLC | Lafayette | Louisiana | 70503 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Revive Research Institute | Farmington Hills | Michigan | 48334 | — |
| Clinical Research Institute of Michigan | Troy | Michigan | 48098 | — |
| Sanmora Bespoke Clinical Research Solutions, LLC. | East Orange | New Jersey | 07018 | — |
| Westchester Putnam Gastro | Carmel | New York | 10512 | — |
| Peters Medical Research | High Point | North Carolina | 27260 | — |
| M3 Wake Research, Inc | Raleigh | North Carolina | 27612 | — |
| Gastro Health Research | Cincinnati | Ohio | 45219 | — |
| NexGen Research | Lima | Ohio | 45805 | — |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | — |
| Susquehanna Research Group, LLC | Harrisburg | Pennsylvania | 17110 | — |
| Guthrie Medical Group, PC | Sayre | Pennsylvania | 18840 | — |
| Gastroenterology Associates | Greenville | South Carolina | 29601 | — |
| Gastro Associates of Greenville | Greenville | South Carolina | 29607 | — |
| ClinSearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Tri-Cities Gastroenterology | Kingsport | Tennessee | 37663 | — |
| Allied Digestive Disease Center | Cypress | Texas | 77429 | — |
| Dr. Mouhamad R. Al-Sabbagh | Houston | Texas | 77043 | — |
| Elixir Research Group | Houston | Texas | 77077 | — |
| Digestive Health Associates | Houston | Texas | 77204 | — |
| Aspira International | Pasadena | Texas | 77502 | — |
| LINQ Research LLC | Pearland | Texas | 77584 | — |
| Southern Star Research Institute, LLC. | San Antonio | Texas | 78229 | — |
| Medrasa Clinical | Sherman | Texas | 75092 | — |
| Spring Gastroenterology Associates | Spring | Texas | 77379 | — |
| Texas Gastroenterology Associates | Spring | Texas | 77386 | — |
| Velocity Clinical Research/Gut Whisperer | West Jordan | Utah | 84088 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 138 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04469686, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04469686 live on ClinicalTrials.gov.