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Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories
Sponsor: Cristcot HCA LLC
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 suppository applicator for the treatment of ulcerative colitis of the rectum.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2020-12-10
Completion Date
2024-09-19
Last Updated
2026-08-06
Healthy Volunteers
No
Conditions
Interventions
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
Once daily 90 mg hydrocortisone acetate or placebo 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
Twice daily placebo suppository administered with Sephure applicator
Locations (189)
Clinical Research Associates LLC
Huntsville, Alabama, United States
Om Research
Apple Valley, California, United States
Om Research
Camarillo, California, United States
Precision Research
El Cajon, California, United States
Om Research
Lancaster, California, United States
Southern CA Research Institute Medical Group/W Gastroenterology Medical Group
Los Angeles, California, United States
Cornell Medical Research
Newport Beach, California, United States
California Medical Research Associates Inc
Northridge, California, United States
Clinical Applications Laboratories Inc
San Diego, California, United States
I.H.S. Health, LLC
Kissimmee, Florida, United States
Homestead Associates in Research
Miami, Florida, United States
Rejuvaline Medical Research
Miami, Florida, United States
Ezy Medical Research, Co.
Miami, Florida, United States
US Associates In Research
Miami, Florida, United States
Gastro Health Research of Miami
Miami, Florida, United States
GI PROS Research
Naples, Florida, United States
Gastroenterology of Greater Orlando
Orange City, Florida, United States
Revival Clinical Research
Orlando, Florida, United States
BRCR Global Clinical Research
Plantation, Florida, United States
International Center for Research
Tampa, Florida, United States
One Health Research Clinic Atlanta
Johns Creek, Georgia, United States
Comprehensive Gastrointestinal Health, LLC
Northbrook, Illinois, United States
Cedar Valley Medical Specialists, P.C.
Waterloo, Iowa, United States
Combined Gastro LLC
Lafayette, Louisiana, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Revive Research Institute
Farmington Hills, Michigan, United States
Clinical Research Institute of Michigan
Troy, Michigan, United States
Sanmora Bespoke Clinical Research Solutions, LLC.
East Orange, New Jersey, United States
Westchester Putnam Gastro
Carmel, New York, United States
Peters Medical Research
High Point, North Carolina, United States
M3 Wake Research, Inc
Raleigh, North Carolina, United States
Gastro Health Research
Cincinnati, Ohio, United States
NexGen Research
Lima, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, United States
Guthrie Medical Group, PC
Sayre, Pennsylvania, United States
Gastroenterology Associates
Greenville, South Carolina, United States
Gastro Associates of Greenville
Greenville, South Carolina, United States
ClinSearch, LLC
Chattanooga, Tennessee, United States
Tri-Cities Gastroenterology
Kingsport, Tennessee, United States
Allied Digestive Disease Center
Cypress, Texas, United States
Dr. Mouhamad R. Al-Sabbagh
Houston, Texas, United States
Elixir Research Group
Houston, Texas, United States
Digestive Health Associates
Houston, Texas, United States
Aspira International
Pasadena, Texas, United States
LINQ Research LLC
Pearland, Texas, United States
Southern Star Research Institute, LLC.
San Antonio, Texas, United States
Medrasa Clinical
Sherman, Texas, United States
Spring Gastroenterology Associates
Spring, Texas, United States
Texas Gastroenterology Associates
Spring, Texas, United States
Velocity Clinical Research/Gut Whisperer
West Jordan, Utah, United States
Hospital Sveti Panteleimon
Plovdiv, Bulgaria
Medical Center Hipokrat - H
Plovdiv, Bulgaria
LTD Diagnostic Consultative Center 1
Sliven, Bulgaria
Medical Center Excelsior 2
Sofia, Bulgaria
Medical Center Excelsior
Sofia, Bulgaria
University Hospital Tsaritsa Yoanna-ISUL
Sofia, 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, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Zealand University Hospital, Koge
Køge, Denmark
CHU Lille - Hôpital Claude Huriez
Lille, Cedex, France
CHU TOURS. Service d'hépato-Gastro-entérologie
Chambray-lès-Tours, France
CHU Montpellier - Hopital Saint Eloi
Montpellier, France
Hôpital Lyon Sud - HCL
Pierre-Bénite, France
CHU de Saint-Étienne
Saint-Priest-en-Jarez, France
Hopital Rangueil
Toulouse, France
JSC,, Vian"
Kutaisi, Georgia
LTD "Aversi Clinic"
Tbilisi, Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, Georgia
LTD "Multi-Profile Clinic Consilium Medulla"
Tbilisi, Georgia
Praxis Dr. Michael R. Mross
Berlin, Germany
Studiengesellschaft BSF UG
Halle, Germany
EuGastro GmbH
Leipzig, Germany
Gastro Campus Research GbR
Münster, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH
Saarbrücken, Germany
Ahmedabad Bariatrics & Cosmetics Private Limited (Asian Bariatrics)
Ahmedabad, Gujarat, India
ICON Hospital
Ahmedabad, Gujarat, India
Sanjivani Superspeciality Hospital
Ahmedabad, Gujarat, India
Gujarat Gastro and Vascular Hospital
Surat, Gujarat, India
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital
Mumbai, Maharashtra, India
Midas Institute of Gastroenterology
Nagpur, Maharashtra, India
B.J. Government Medical College and Sassoon General Hospital
Pune, Maharashtra, India
Ashwin Medical Foundation Multispeciality Hospital
Pune, Maharashtra, India
Acharya Vinoba Bhave Rural Hospital
Wardha, Maharashtra, India
Sir Ganga Ram Hospital,
Delhi, National Capital Territory of Delhi, India
Pushpawati Singhania Research Institute
New Delhi, New Delhi, India
SMS Medical College & Hospital
Jaipur, Rajasthan, India
SIMS Hospital
Chennai, Tamil Nadu, India
Università di Cagliari, Dipartimento di Scienze mediche e sanità pubblica
Monserrato, Cagliari, Italy
Ospedale: Azienda Policlinico Universitario Bari
Bari, Italy
Università della Campania "Luigi Vanvitelli"
Naples, Italy
Ospedale di Padova
Padova, Italy
A.O. Ordine Mauriziano di Torino
Torino, Italy
Al Khalidi Hospital and Medical Center
Amman, Jordan
Istishari Hospital
Amman, Jordan
The Specialty Hospital Advanced Clinical Center
Amman, Jordan