Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories

July 29, 2025 updated by: Cristcot LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hydrocortisone acetate 90 mg or placebo will be administered as a rectal suppository with a Sephure suppository applicator. Two arms of the study will receive different dosage regimens of hydrocortisone acetate, and the third arm will receive placebo. All subjects will administer the study drug twice a day; once in the morning and once in the evening for 28 days.

The study population will consist of male and non pregnant, non lactating females aged 18 years and older with a confirmed diagnosis of active UC of the rectum.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Hospital Sveti Panteleimon
      • Plovdiv, Bulgaria, 4003
        • Medical Center Hipokrat - H
      • Sliven, Bulgaria, 8801
        • LTD Diagnostic Consultative Center 1
      • Sofia, Bulgaria, 1407
        • Medical Center Excelsior
      • Sofia, Bulgaria, 1407
        • Medical Center Excelsior 2
      • Sofia, Bulgaria, 1527
        • University Hospital Tsaritsa Yoanna-ISUL
  • China
      • Hong Kong, China
        • Queen Mary Hospital
      • Hong Kong, China
        • Tuen Mun Hospital
      • Hong Kong, China
        • Alice Ho Miu Ling Nethersole Hospital
      • Hong Kong, China
        • Humanity & Health Clinical Trial Centre
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • Køge, Denmark, 4600
        • Zealand University Hospital, Koge
  • France
      • Chambray-lès-Tours, France, 37170
        • CHU TOURS. Service d'hépato-Gastro-entérologie
      • Montpellier, France, 34090
        • CHU Montpellier - Hôpital Saint Eloi
      • Pierre-Bénite, France, 69495
        • Hopital Lyon Sud - Hcl
      • Saint-Priest-en-Jarez, France, 42270
        • CHU de Saint-Etienne
      • Toulouse, France, 31059
        • Hôpital Rangueil
    • Cedex
      • Lille, Cedex, France, 59037
        • CHU Lille - Hôpital Claude Huriez
  • Georgia
      • Kutaisi, Georgia, 4600
        • JSC,, Vian"
      • Tbilisi, Georgia, 0160
        • LTD "Aversi Clinic"
      • Tbilisi, Georgia, 144
        • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
      • Tbilisi, Georgia, 186
        • LTD "Multi-Profile Clinic Consilium Medulla"
  • Germany
      • Berlin, Germany, 10318
        • Praxis Dr. Michael R. Mross
      • Halle, Germany, 06108
        • Studiengesellschaft BSF UG
      • Leipzig, Germany, 04103
        • Eugastro GmbH
      • Münster, Germany, 48159
        • Gastro Campus Research GbR
      • Saarbrücken, Germany, 66111
        • Zentrum für Gastroenterologie Saar MVZ GmbH
  • India
      • Delhi, India, 110060
        • Sir Ganga Ram Hospital,
      • New Delhi, India, 110017
        • Pushpawati Singhania Research Institute
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • ICON Hospital
      • Ahmedabad, Gujarat, India, 380015
        • Ahmedabad Bariatrics & Cosmetics Private Limited (Asian Bariatrics)
      • Ahmedabad, Gujarat, India, 380051
        • Sanjivani Superspeciality Hospital
      • Surat, Gujarat, India, 395009
        • Gujarat Gastro and Vascular Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400022
        • Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital
      • Nagpur, Maharashtra, India, 440010
        • Midas Institute of Gastroenterology
      • Pune, Maharashtra, India, 411001
        • B.J. Government Medical College and Sassoon General Hospital
      • Pune, Maharashtra, India, 411033
        • Ashwin Medical Foundation Multispeciality Hospital
      • Wardha, Maharashtra, India, 442004
        • Acharya Vinoba Bhave Rural Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • SMS Medical College & Hospital
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600026
        • SIMS Hospital
  • Italy
      • Bari, Italy, 70124
        • Ospedale: Azienda Policlinico Universitario Bari
      • Napoli, Italy, 80138
        • Università della Campania "Luigi Vanvitelli"
      • Padova, Italy, 35128
        • Ospedale di Padova
      • Torino, Italy, 10128
        • A.O. Ordine Mauriziano di Torino
    • Cagliari
      • Monserrato, Cagliari, Italy, 09042
        • Università di Cagliari, Dipartimento di Scienze mediche e sanità pubblica
  • Jordan
      • Amman, Jordan, 11942
        • Jordan University Hospital
      • Amman, Jordan, 11184
        • Istishari Hospital
      • Amman, Jordan, 11196
        • Istiklal Hospital
      • Amman, Jordan, 11183
        • Al Khalidi Hospital and Medical Center
      • Amman, Jordan, 11194
        • The Specialty Hospital Advanced Clinical Center
      • Irbid, Jordan, 22110
        • Pharmaceutical Research Center/Jordan University of Science and Technology
      • Irbid, Jordan, 22110
        • Irbid Specialty Hospital/Clinical Research Center
  • Lebanon
      • Beirut, Lebanon, 1100
        • Saint George Hospital University Medical Center
      • Beirut, Lebanon, 22411
        • Dr. Bilal Hotayt Gastroenterology
      • Sidon, Lebanon, 1600
        • Hammoud Hospital University Medical Center
  • Libyan Arab Jamahiriya
      • Tripoli, Libyan Arab Jamahiriya, 1300
        • Nini Hospital
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, MD 2025
        • Institutul de Cardiologie Consultative Department, RTL Clinic
      • Chisinau, Moldova, Republic of, MD 2025
        • Republican Hospital "Timofei Moșneaga", Consultative Department, Policlinic
  • Philippines
      • Cebu City, Philippines, 6000
        • Cebu Doctors' University Hospital
      • Iloilo City, Philippines, 5000
        • West Visayas State University Medical Center
      • Iloilo City, Philippines, 5000
        • The Medical City Iloilo
      • Mabalacat, Philippines, 2023
        • The Medical City Clark
      • Makati City, Philippines, 1229
        • Makati Medical Center
      • Manila, Philippines, 1000
        • Manila Doctors Hospital
      • Pasig, Philippines, 1605
        • The Medical City Ortigas
      • Quezon City, Philippines
        • St. Luke's Medical Center
      • Quezon City, Philippines, 1101
        • National Kidney and Transplant Institute
      • San Juan, Philippines, 1502
        • Cardinal Santos Medical Center (CSMC)
  • Poland
      • Bydgoszcz, Poland, 85-079
        • Vitamed Galaj i Cichomski sp.j.
      • Bydgoszcz, Poland, 85-794
        • Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Malgorzata Trzaska
      • Chojnice, Poland, 89-600
        • Centrum Medyczne Lukamed Joanna Luka Wendrowska
      • Chrzanów, Poland, 32-500
        • Centrum Medyczne MBB-MED
      • Grudziądz, Poland, 86-300
        • Centrum Medyczne CLW-MED Aneta Cichomska, Joanna Luka-Wendrowska
      • Jelenia Góra, Poland, 58-500
        • Karkonoskie Centrum Badan Klinicznych Lexmedica Sp. z o.o
      • Ksawerów, Poland, 95-054
        • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
      • Rzeszów, Poland, 35-302
        • Korczowski Bartosz, Gabinet Lekarski
      • Szczecin, Poland, 71-685
        • Sonomed Sp. z o.o.
      • Warszawa, Poland, 02-798
        • Medical Concierge Centrum Medyczne
      • Warszawa, Poland, 04-501
        • Medical Network Spółka z o.o.
      • Wrocław, Poland, 50-449
        • Melita Medical Centrum Medyczne
      • Łódź, Poland, 91-495
        • AmiCare Sp. z o.o. Sp. k.
    • Lubuskie
      • Nowa Sól, Lubuskie, Poland, 67-100
        • Twoja Przychodnia - Centrum Medyczne Nowa Sol
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 71-434
        • Uromed Jakub Koteras Twoja Przychodnia- Szczecińskie Centrum Medyczne
  • Romania
      • Bucharest, Romania, 050098
        • Spitalul Universitar de Urgență București
      • Bucharest, Romania, 020125
        • Spitalul Clinic Colentina
      • Bucharest, Romania, 020475
        • Spitalul Clinic 'Dr Ion Cantacuzino'
      • Bucharest, Romania, 022328
        • Clinical Institute Fundeni, Gastro Enterology Department No.2
      • Cluj-Napoca, Romania, 400394
        • Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor" Cluj-Napoca
      • Iasi, Romania, 707401
        • Gastromedical SRL
      • Timişoara, Romania
        • Centrul de Gastroenterologie Dr. Goldis
      • Târgu-Mureş, Romania, 540103
        • Tirgu-Mures Country Clinical Hospital
  • Russian Federation
      • Ryazan', Russian Federation, 390039
        • 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"
      • Saint Petersburg, Russian Federation, 191015
        • 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, Russian Federation, 191015
        • 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, Russian Federation, 197110
        • LLC 'Polyclinic EXPERT'
      • Saint Petersburg, Russian Federation, 199226
        • Federal State Budgetary Educational Institution of Higher Education Saint Petersburg State University, Clinic of advanced medical technologies n.a. Nicolay I. Pirogov
      • Saratov, Russian Federation, 410071
        • State Budgetary Healthcare Institution "Saratov City Clinical Hospital # 5
      • Smolensk, Russian Federation, 214019
        • Regional State Budgetary Institution of Health "Clinical Hospital №1"
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21589
        • King AbdulAziz University Hospital
      • Jeddah, Saudi Arabia, 21423
        • National Guard Hospital Jeddah
      • Riyadh, Saudi Arabia, 11525
        • King Fahad Medical City
      • Riyadh, Saudi Arabia, 12372
        • King Khalid University Hospital
      • Riyadh, Saudi Arabia, 11223311159
        • Prince Sultan Military Medical City
      • Riyadh, Saudi Arabia, 11426
        • National Guard Hospital Riyadh
  • South Africa
    • Gauteng
      • Benoni, Gauteng, South Africa, 1500
        • Worthwhile Clinical Trials
    • Guauteng
      • Johannesburg, Guauteng, South Africa, 2193
        • Wits Clinical Research
      • Pretoria, Guauteng, South Africa, 0002
        • EMMED
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7800
        • Inspired GI Care
  • Spain
      • Madrid, Spain, 28006
        • Hospital La Princesa
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos and Instituto de Investigación del Hospital Clínico San Carlos (IdISSC)
      • Toledo, Spain, 45007
        • Hospital Virgen de la Salud
    • Islas Canarias
      • Las Palmas De Gran Canaria, Islas Canarias, Spain, 35010
        • Hospital Dr. Negrín
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
  • Turkey
      • Antalya, Turkey, 07100
        • SBÜ. Antalya Eğirim ve Araştırma Hastanesi, Gastroenteroloji
      • Istanbul, Turkey, 34899
        • Marmara Universitesi Pendik Eğitim Araştırma Hastanesi, Gastroenteroloji
      • Mersin, Turkey, 33110
        • Mersin Universitesi Tip Fakultesi, Gastroenteroloji
      • Trabzon, Turkey, 61080
        • Karadeniz Teknik Üniversitesi Tıp Fakütesi Hastanesi Gastroenteroloji
      • İzmir, Turkey, 35100
        • Ege Universitesi Tip Fakultesi Hastanesi, Gastroenteroloji
  • Ukraine
      • Kharkiv, Ukraine, 61037
        • Municipal non-profit enterprise "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov" of Kharkiv City Council
      • Kropyvnytskyi, Ukraine, 25006
        • Private Enterprise Private Manufacturing Company "Acinus"
      • Kyiv, Ukraine, 01030
        • Municipal non-profit enterprise "Kyiv City Clinical Hospital No. 18" of the executive body of the Kyiv City Council (Kyiv City State Administration)
      • Lviv, Ukraine, 79010
        • Comunal NonCommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
      • Odesa, Ukraine, 65025
        • Municipal non-profit enterprise "Odesa Regional Clinical Hospital of the Odesa Regional Council", Regional Gastroenterological Center
      • Ternopil', Ukraine, 46002
        • Ternopil University Hospital
      • Vinnytsia, Ukraine, 21028
        • Municipal non-profit enterprise "M.I. Pyrogov Vinnytsya Regional Clinical Hospital of the Vinnytsya Regional Council"; National Pirogov Memorial Medical University, Vinnytsya
      • Vinnytsia, Ukraine, 21029
        • Municipal non-profit enterprise "Vinnytsya City Clinical Hospital №1"; National Pirogov Memorial Medical University, Vinnytsya
      • Zhytomyr, Ukraine, 10003
        • Limited Liability Company "Medibor"
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates LLC
    • California
      • Apple Valley, California, United States, 92307
        • Om Research
      • Camarillo, California, United States, 93012
        • Om Research
      • El Cajon, California, United States, 92020
        • Precision Research
      • Lancaster, California, United States, 93534
        • Om Research
      • Los Angeles, California, United States, 90045
        • Southern CA Research Institute Medical Group/W Gastroenterology Medical Group
      • Newport Beach, California, United States, 92663
        • Cornell Medical Research
      • Northridge, California, United States, 91324
        • California Medical Research Associates Inc
      • San Diego, California, United States, 92103
        • Clinical Applications Laboratories Inc
    • Florida
      • Kissimmee, Florida, United States, 34741
        • I.H.S. Health, LLC
      • Miami, Florida, United States, 33032
        • Homestead Associates in Research
      • Miami, Florida, United States, 33175
        • Ezy Medical Research, Co.
      • Miami, Florida, United States, 33175
        • US Associates in Research
      • Miami, Florida, United States, 33155
        • Rejuvaline Medical Research
      • Miami, Florida, United States, 33176
        • Gastro Health Research of Miami
      • Naples, Florida, United States, 34102
        • GI Pros Research
      • Orange City, Florida, United States, 32763
        • Gastroenterology of Greater Orlando
      • Orlando, Florida, United States, 32807
        • Revival Clinical Research
      • Plantation, Florida, United States, 33322
        • BRCR Global Clinical Research
      • Tampa, Florida, United States, 33614
        • International Center for Research
    • Georgia
      • Johns Creek, Georgia, United States, 30097
        • One Health Research Clinic Atlanta
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Comprehensive Gastrointestinal Health, LLC
    • Iowa
      • Waterloo, Iowa, United States, 50701
        • Cedar Valley Medical Specialists, P.C.
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Combined Gastro LLC
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
      • Farmington Hills, Michigan, United States, 48334
        • Revive Research Institute
      • Troy, Michigan, United States, 48098
        • Clinical Research Institute of Michigan
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • Sanmora Bespoke Clinical Research Solutions, LLC.
    • New York
      • Carmel, New York, United States, 10512
        • Westchester Putnam Gastro
    • North Carolina
      • High Point, North Carolina, United States, 27260
        • Peters Medical Research
      • Raleigh, North Carolina, United States, 27612
        • M3 Wake Research, Inc
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Gastro Health Research
      • Lima, Ohio, United States, 45805
        • Nexgen Research
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Susquehanna Research Group, LLC
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group, PC
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Gastroenterology Associates
      • Greenville, South Carolina, United States, 29607
        • Gastro Associates of Greenville
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • ClinSearch, LLC
      • Kingsport, Tennessee, United States, 37663
        • Tri-Cities Gastroenterology
    • Texas
      • Cypress, Texas, United States, 77429
        • Allied Digestive Disease Center
      • Houston, Texas, United States, 77077
        • Elixir Research Group
      • Houston, Texas, United States, 77204
        • Digestive Health Associates
      • Houston, Texas, United States, 77043
        • Dr. Mouhamad R. Al-Sabbagh
      • Pasadena, Texas, United States, 77502
        • Aspira International
      • Pearland, Texas, United States, 77584
        • LinQ Research LLC
      • San Antonio, Texas, United States, 78229
        • Southern Star Research Institute, LLC.
      • Sherman, Texas, United States, 75092
        • Medrasa Clinical
      • Spring, Texas, United States, 77386
        • Texas Gastroenterology Associates
      • Spring, Texas, United States, 77379
        • Spring Gastroenterology Associates
    • Utah
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research/Gut Whisperer
  • Vietnam
      • Hanoi, Vietnam, 10000
        • 103 Military Hospital
      • Hanoi, Vietnam, 10000
        • Bach Mai hospital
      • Hanoi, Vietnam, 10000
        • Hanoi Medical University Hospital
      • Hanoi, Vietnam, 10000
        • Viet Duc Hospital
      • Hanoi, Vietnam, 10000
        • Vinmec Hospital
      • Ho Chi Minh City, Vietnam, 70000
        • Nguyen Tri Phuong Hospital
      • Ho Chi Minh City, Vietnam, 70000
        • Gia Dinh People's Hospital
      • Ho Chi Minh City, Vietnam, 70000
        • 115 People's Hospital
      • Ho Chi Minh City, Vietnam, 70000
        • Cho Ray Hospital
      • Huế, Vietnam, 49000
        • Hue Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Twice Daily - Active
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator
Combination product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
Other Names:
  • Twice Daily - Active
Experimental: Once Daily - Active
Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator
Combination product: 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
Other Names:
  • Once Daily - Active
Placebo Comparator: Placebo
Twice daily placebo suppository administered with Sephure suppository applicator
Combination product: Twice daily placebo suppository administered with Sephure applicator
Twice daily placebo suppository administered with Sephure applicator
Other Names:
  • Twice Daily - Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical remission measured using the Modified Mayo Score
Time Frame: 28 days
To evaluate the the efficacy of two dosage regimens of the study drug
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency
Time Frame: 28 days
To assess the change in stool frequency
28 days
Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0
Time Frame: 28 days
To assess the change in rectal bleeding
28 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life assessed measured using IBDQ validated questionnaire
Time Frame: 28 days
To examine the quality of life of patients
28 days
Grading of disease severity measure using Mayo Scoring sub-score of Physician's Global Assessment
Time Frame: 28 days
To assess disease severity
28 days
Concentrations of hydrocortisone acetate using pharmacokinetic sampling
Time Frame: 28 days
To evaluate the exposure of hydrocortisone acetate levels for safety
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cristcot LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cristcot HCA LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jennifer Davagian, Cristcot LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHS1221
  • 2019-003596-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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