Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories
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 Applicator in Subjects With Ulcerative Colitis
2 other identifiers
interventional
200
23 countries
189
Brief Summary
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 applicator for the treatment of ulcerative colitis of the rectum.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2020
Typical duration for phase_3
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2020
CompletedFirst Posted
Study publicly available on registry
July 14, 2020
CompletedStudy Start
First participant enrolled
December 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2024
CompletedJuly 30, 2025
July 1, 2025
3.6 years
July 2, 2020
July 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical remission measured using the Modified Mayo Score
To evaluate the the efficacy of two dosage regimens of the study drug
28 days
Secondary Outcomes (2)
Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency
28 days
Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0
28 days
Other Outcomes (3)
Quality of Life assessed measured using IBDQ validated questionnaire
28 days
Grading of disease severity measure using Mayo Scoring sub-score of Physician's Global Assessment
28 days
Concentrations of hydrocortisone acetate using pharmacokinetic sampling
28 days
Study Arms (3)
Twice Daily - Active
EXPERIMENTALTwice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator
Once Daily - Active
EXPERIMENTALOnce daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator
Placebo
PLACEBO COMPARATORTwice daily placebo suppository administered with Sephure suppository applicator
Interventions
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
Twice daily placebo suppository administered with Sephure applicator
Eligibility Criteria
You may qualify if:
- Male or non pregnant, non lactating females aged 18 years and older.
- Subjects with a confirmed diagnosis of active UC of the rectum, extending no more than 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy performed at Visit 2. Note: Subjects may have a history of more extensive UC (e.g., pancolitis), but have active disease only in the rectum at the time of enrollment.
- Modified Mayo sub score for stool frequency of 1 3.
- Modified Mayo sub score for rectal bleeding of 0 2.
- Modified Mayo endoscopic sub score of 2 3.
- Total Modified Mayo Score (without physician global assessment) of 4-8.
You may not qualify if:
- History or current diagnosis of bacterial or other infectious colitis, radiation enteritis and radiation proctitis, Crohn's disease, collagenous colitis and indeterminate colitis.
- Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia.
- Concomitant active lower gastrointestinal disease (except Irritable Bowel Syndrome) or distortion of intestinal anatomy.
- Bleeding hemorrhoids at the time of enrollment.
- Acute diverticulitis at the time of enrollment.
- Acute or chronic pancreatitis at the time of enrollment.
- Unmanaged celiac disease at the time of enrollment.
- Positive stool test for enteric pathogens, Clostridium difficile, or presence of ova and parasites.
- Taking a prohibited medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cristcot LLClead
- Cristcot HCA LLCcollaborator
Study Sites (189)
Clinical Research Associates LLC
Huntsville, Alabama, 35801, United States
Om Research
Apple Valley, California, 92307, United States
Om Research
Camarillo, California, 93012, United States
Precision Research
El Cajon, California, 92020, United States
Om Research
Lancaster, California, 93534, United States
Southern CA Research Institute Medical Group/W Gastroenterology Medical Group
Los Angeles, California, 90045, United States
Cornell Medical Research
Newport Beach, California, 92663, United States
California Medical Research Associates Inc
Northridge, California, 91324, United States
Clinical Applications Laboratories Inc
San Diego, California, 92103, United States
I.H.S. Health, LLC
Kissimmee, Florida, 34741, United States
Homestead Associates in Research
Miami, Florida, 33032, United States
Rejuvaline Medical Research
Miami, Florida, 33155, United States
Ezy Medical Research, Co.
Miami, Florida, 33175, United States
US Associates In Research
Miami, Florida, 33175, United States
Gastro Health Research of Miami
Miami, Florida, 33176, United States
GI PROS Research
Naples, Florida, 34102, United States
Gastroenterology of Greater Orlando
Orange City, Florida, 32763, United States
Revival Clinical Research
Orlando, Florida, 32807, United States
BRCR Global Clinical Research
Plantation, Florida, 33322, United States
International Center for Research
Tampa, Florida, 33614, United States
One Health Research Clinic Atlanta
Johns Creek, Georgia, 30097, United States
Comprehensive Gastrointestinal Health, LLC
Northbrook, Illinois, 60062, United States
Cedar Valley Medical Specialists, P.C.
Waterloo, Iowa, 50701, United States
Combined Gastro LLC
Lafayette, Louisiana, 70503, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Revive Research Institute
Farmington Hills, Michigan, 48334, United States
Clinical Research Institute of Michigan
Troy, Michigan, 48098, United States
Sanmora Bespoke Clinical Research Solutions, LLC.
East Orange, New Jersey, 07018, United States
Westchester Putnam Gastro
Carmel, New York, 10512, United States
Peters Medical Research
High Point, North Carolina, 27260, United States
M3 Wake Research, Inc
Raleigh, North Carolina, 27612, United States
Gastro Health Research
Cincinnati, Ohio, 45219, United States
NexGen Research
Lima, Ohio, 45805, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, 17110, United States
Guthrie Medical Group, PC
Sayre, Pennsylvania, 18840, United States
Gastroenterology Associates
Greenville, South Carolina, 29601, United States
Gastro Associates of Greenville
Greenville, South Carolina, 29607, United States
ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Tri-Cities Gastroenterology
Kingsport, Tennessee, 37663, United States
Allied Digestive Disease Center
Cypress, Texas, 77429, United States
Dr. Mouhamad R. Al-Sabbagh
Houston, Texas, 77043, United States
Elixir Research Group
Houston, Texas, 77077, United States
Digestive Health Associates
Houston, Texas, 77204, United States
Aspira International
Pasadena, Texas, 77502, United States
LINQ Research LLC
Pearland, Texas, 77584, United States
Southern Star Research Institute, LLC.
San Antonio, Texas, 78229, United States
Medrasa Clinical
Sherman, Texas, 75092, United States
Spring Gastroenterology Associates
Spring, Texas, 77379, United States
Texas Gastroenterology Associates
Spring, Texas, 77386, United States
Velocity Clinical Research/Gut Whisperer
West Jordan, Utah, 84088, United States
Hospital Sveti Panteleimon
Plovdiv, 4000, Bulgaria
Medical Center Hipokrat - H
Plovdiv, 4003, Bulgaria
LTD Diagnostic Consultative Center 1
Sliven, 8801, Bulgaria
Medical Center Excelsior 2
Sofia, 1407, Bulgaria
Medical Center Excelsior
Sofia, 1407, Bulgaria
University Hospital Tsaritsa Yoanna-ISUL
Sofia, 1527, Bulgaria
Alice Ho Miu Ling Nethersole Hospital
Hong Kong, China
Humanity & Health Clinical Trial Centre
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Tuen Mun Hospital
Hong Kong, China
Aalborg University Hospital
Aalborg, 9000, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Zealand University Hospital, Koge
Køge, 4600, Denmark
CHU Lille - Hôpital Claude Huriez
Lille, Cedex, 59037, France
CHU TOURS. Service d'hépato-Gastro-entérologie
Chambray-lès-Tours, 37170, France
CHU Montpellier - Hopital Saint Eloi
Montpellier, 34090, France
Hôpital Lyon Sud - HCL
Pierre-Bénite, 69495, France
CHU de Saint-Étienne
Saint-Priest-en-Jarez, 42270, France
Hopital Rangueil
Toulouse, 31059, France
JSC,, Vian"
Kutaisi, 4600, Georgia
LTD "Aversi Clinic"
Tbilisi, 0160, Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, 144, Georgia
LTD "Multi-Profile Clinic Consilium Medulla"
Tbilisi, 186, Georgia
Praxis Dr. Michael R. Mross
Berlin, 10318, Germany
Studiengesellschaft BSF UG
Halle, 06108, Germany
EuGastro GmbH
Leipzig, 04103, Germany
Gastro Campus Research GbR
Münster, 48159, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH
Saarbrücken, 66111, Germany
Ahmedabad Bariatrics & Cosmetics Private Limited (Asian Bariatrics)
Ahmedabad, Gujarat, 380015, India
ICON Hospital
Ahmedabad, Gujarat, 380015, India
Sanjivani Superspeciality Hospital
Ahmedabad, Gujarat, 380051, India
Gujarat Gastro and Vascular Hospital
Surat, Gujarat, 395009, India
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital
Mumbai, Maharashtra, 400022, India
Midas Institute of Gastroenterology
Nagpur, Maharashtra, 440010, India
B.J. Government Medical College and Sassoon General Hospital
Pune, Maharashtra, 411001, India
Ashwin Medical Foundation Multispeciality Hospital
Pune, Maharashtra, 411033, India
Acharya Vinoba Bhave Rural Hospital
Wardha, Maharashtra, 442004, India
SMS Medical College & Hospital
Jaipur, Rajasthan, 302004, India
SIMS Hospital
Chennai, Tamil Nadu, 600026, India
Sir Ganga Ram Hospital,
Delhi, 110060, India
Pushpawati Singhania Research Institute
New Delhi, 110017, India
Università di Cagliari, Dipartimento di Scienze mediche e sanità pubblica
Monserrato, Cagliari, 09042, Italy
Ospedale: Azienda Policlinico Universitario Bari
Bari, 70124, Italy
Università della Campania "Luigi Vanvitelli"
Napoli, 80138, Italy
Ospedale di Padova
Padua, 35128, Italy
A.O. Ordine Mauriziano di Torino
Torino, 10128, Italy
Al Khalidi Hospital and Medical Center
Amman, 11183, Jordan
Istishari Hospital
Amman, 11184, Jordan
The Specialty Hospital Advanced Clinical Center
Amman, 11194, Jordan
Istiklal Hospital
Amman, 11196, Jordan
Jordan University Hospital
Amman, 11942, Jordan
Irbid Specialty Hospital/Clinical Research Center
Irbid, 22110, Jordan
Pharmaceutical Research Center/Jordan University of Science and Technology
Irbid, 22110, Jordan
Saint George Hospital University Medical Center
Beirut, 1100, Lebanon
Dr. Bilal Hotayt Gastroenterology
Beirut, 22411, Lebanon
Hammoud Hospital University Medical Center
Sidon, 1600, Lebanon
Nini Hospital
Tripoli, 1300, Libya
Institutul de Cardiologie Consultative Department, RTL Clinic
Chisinau, MD 2025, Moldova
Republican Hospital "Timofei Moșneaga", Consultative Department, Policlinic
Chisinau, MD 2025, Moldova
Cebu Doctors' University Hospital
Cebu City, 6000, Philippines
The Medical City Iloilo
Iloilo City, 5000, Philippines
West Visayas State University Medical Center
Iloilo City, 5000, Philippines
The Medical City Clark
Mabalacat, 2023, Philippines
Makati Medical Center
Makati City, 1229, Philippines
Manila Doctors Hospital
Manila, 1000, Philippines
The Medical City Ortigas
Pasig, 1605, Philippines
National Kidney and Transplant Institute
Quezon City, 1101, Philippines
St. Luke's Medical Center
Quezon City, Philippines
Cardinal Santos Medical Center (CSMC)
San Juan City, 1502, Philippines
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
Uromed Jakub Koteras Twoja Przychodnia- Szczecińskie Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
Vitamed Galaj i Cichomski Sp.j.
Bydgoszcz, 85-079, Poland
Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, 85-794, Poland
Centrum Medyczne Lukamed Joanna Luka Wendrowska
Chojnice, 89-600, Poland
Centrum Medyczne MBB-MED
Chrzanów, 32-500, Poland
Centrum Medyczne CLW-MED Aneta Cichomska, Joanna Luka-Wendrowska
Grudziądz, 86-300, Poland
Karkonoskie Centrum Badan Klinicznych Lexmedica Sp. z o.o
Jelenia Góra, 58-500, Poland
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów, 95-054, Poland
AMICARE Sp. z o.o. sp. k.
Lodz, 91-495, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302, Poland
Sonomed Sp. z o.o.
Szczecin, 71-685, Poland
Medical Concierge Centrum Medyczne
Warsaw, 02-798, Poland
Medical Network Spółka z o.o.
Warsaw, 04-501, Poland
Melita Medical Centrum Medyczne
Wroclaw, 50-449, Poland
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Spitalul Clinic 'Dr Ion Cantacuzino'
Bucharest, 020475, Romania
Clinical Institute Fundeni, Gastro Enterology Department No.2
Bucharest, 022328, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098, Romania
Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor" Cluj-Napoca
Cluj-Napoca, 400394, Romania
Gastromedical SRL
Iași, 707401, Romania
Tirgu-Mures Country Clinical Hospital
Târgu Mureş, 540103, Romania
Centrul de Gastroenterologie Dr. Goldis
Timișoara, Romania
SBI of HE "Ryazan State Medical University n.a. ac. I.P. Pavlov" of the MoH of the RF on the base of the SBI of the Ryazan Region "Regional Clinical Hospital"
Ryazan, 390039, Russia
Federal State Budgetary Military Educational Institution of Higher Education "Military and Medical Academy named after S.M. Kirov" of the Ministry of Defence of the Russian Federation; 2nd Therapy Chair for Advanced Training of Physicians
Saint Petersburg, 191015, Russia
Federal State Budgetary Military Educational Institution of Higher Education "Military and Medical Academy named after S.M. Kirov" of the Ministry of Defense of the Russian Federation; Chair and Clinic of Hospital Therapy n. a. Professor V.N. Sirotinin
Saint Petersburg, 191015, Russia
LLC 'Polyclinic EXPERT'
Saint Petersburg, 197110, Russia
Federal State Budgetary Educational Institution of Higher Education Saint Petersburg State University, Clinic of advanced medical technologies n.a. Nicolay I. Pirogov
Saint Petersburg, 199226, Russia
State Budgetary Healthcare Institution "Saratov City Clinical Hospital # 5
Saratov, 410071, Russia
Regional State Budgetary Institution of Health "Clinical Hospital №1"
Smolensk, 214019, Russia
National Guard Hospital Jeddah
Jeddah, 21423, Saudi Arabia
King Abdulaziz University Hospital
Jeddah, 21589, Saudi Arabia
Prince Sultan Military Medical City
Riyadh, 11223311159, Saudi Arabia
National Guard Hospital Riyadh
Riyadh, 11426, Saudi Arabia
King Fahad Medical City
Riyadh, 11525, Saudi Arabia
King Khalid University Hospital
Riyadh, 12372, Saudi Arabia
Worthwhile Clinical Trials
Benoni, Gauteng, 1500, South Africa
Wits Clinical Research
Johannesburg, Guauteng, 2193, South Africa
EMMED
Pretoria, Guauteng, 0002, South Africa
Inspired GI Care
Cape Town, Western Cape, 7800, South Africa
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, 35010, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Hospital La Princesa
Madrid, 28006, Spain
Hospital Clínico San Carlos and Instituto de Investigación del Hospital Clínico San Carlos (IdISSC)
Madrid, 28040, Spain
Hospital Virgen de la Salud
Toledo, 45007, Spain
SBÜ. Antalya Eğirim ve Araştırma Hastanesi, Gastroenteroloji
Antalya, 07100, Turkey (Türkiye)
Marmara Universitesi Pendik Eğitim Araştırma Hastanesi, Gastroenteroloji
Istanbul, 34899, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi, Gastroenteroloji
Izmir, 35100, Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi, Gastroenteroloji
Mersin, 33110, Turkey (Türkiye)
Karadeniz Teknik Üniversitesi Tıp Fakütesi Hastanesi Gastroenteroloji
Trabzon, 61080, Turkey (Türkiye)
Municipal non-profit enterprise "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov" of Kharkiv City Council
Kharkiv, 61037, Ukraine
Private Enterprise Private Manufacturing Company "Acinus"
Kropyvnytskyi, 25006, Ukraine
Municipal non-profit enterprise "Kyiv City Clinical Hospital No. 18" of the executive body of the Kyiv City Council (Kyiv City State Administration)
Kyiv, 01030, Ukraine
Comunal NonCommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
Lviv, 79010, Ukraine
Municipal non-profit enterprise "Odesa Regional Clinical Hospital of the Odesa Regional Council", Regional Gastroenterological Center
Odesa, 65025, Ukraine
Ternopil University Hospital
Ternopil, 46002, Ukraine
Municipal non-profit enterprise "M.I. Pyrogov Vinnytsya Regional Clinical Hospital of the Vinnytsya Regional Council"; National Pirogov Memorial Medical University, Vinnytsya
Vinnytsia, 21028, Ukraine
Municipal non-profit enterprise "Vinnytsya City Clinical Hospital №1"; National Pirogov Memorial Medical University, Vinnytsya
Vinnytsia, 21029, Ukraine
Limited Liability Company "Medibor"
Zhytomyr, 10003, Ukraine
103 Military Hospital
Hanoi, 10000, Vietnam
Bach Mai Hospital
Hanoi, 10000, Vietnam
Hanoi Medical University Hospital
Hanoi, 10000, Vietnam
Viet Duc Hospital
Hanoi, 10000, Vietnam
Vinmec Hospital
Hanoi, 10000, Vietnam
115 People's Hospital
Ho Chi Minh City, 70000, Vietnam
Cho Ray Hospital
Ho Chi Minh City, 70000, Vietnam
Gia Dinh People's Hospital
Ho Chi Minh City, 70000, Vietnam
Nguyen Tri Phuong Hospital
Ho Chi Minh City, 70000, Vietnam
Hue Central Hospital
Huế, 49000, Vietnam
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Jennifer Davagian
Cristcot LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2020
First Posted
July 14, 2020
Study Start
December 10, 2020
Primary Completion
July 16, 2024
Study Completion
September 19, 2024
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share