Ulcerative ProctitisPhase 3NCT04469686
Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories
A Phase 3 study testing Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator in people with Ulcerative Proctitis, run by Cristcot HCA LLC at 189 sites in 23 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Proctitis
- What is being tested?
- Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 189 sitesin 23 countries
- Study dates
- 10 Dec 2020to 19 Sep 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non pregnant, non lactating females aged 18 years and older.
- Able to provide informed consent.
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
189 sites in 23 countries.
189 sites in 23 countries
United States51 sites
Om Research
Apple Valley, California, 92307
Om Research
Camarillo, California, 93012
Westchester Putnam Gastro
Carmel, New York, 10512
ClinSearch, LLC
Chattanooga, Tennessee, 37421
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
Gastro Health Research
Cincinnati, Ohio, 45219
Allied Digestive Disease Center
Cypress, Texas, 77429
Sanmora Bespoke Clinical Research Solutions, LLC.
East Orange, New Jersey, 07018
Precision Research
El Cajon, California, 92020
Revive Research Institute
Farmington Hills, Michigan, 48334
Gastroenterology Associates
Greenville, South Carolina, 29601
Gastro Associates of Greenville
Greenville, South Carolina, 29607
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, 17110
Peters Medical Research
High Point, North Carolina, 27260
Dr. Mouhamad R. Al-Sabbagh
Houston, Texas, 77043
Elixir Research Group
Houston, Texas, 77077
Digestive Health Associates
Houston, Texas, 77204
Clinical Research Associates LLC
Huntsville, Alabama, 35801
One Health Research Clinic Atlanta
Johns Creek, Georgia, 30097
Tri-Cities Gastroenterology
Kingsport, Tennessee, 37663
I.H.S. Health, LLC
Kissimmee, Florida, 34741
Combined Gastro LLC
Lafayette, Louisiana, 70503
Om Research
Lancaster, California, 93534
NexGen Research
Lima, Ohio, 45805
Southern CA Research Institute Medical Group/W Gastroenterology Medical Group
Los Angeles, California, 90045
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
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
Cornell Medical Research
Newport Beach, California, 92663
Comprehensive Gastrointestinal Health, LLC
Northbrook, Illinois, 60062
California Medical Research Associates Inc
Northridge, California, 91324
Gastroenterology of Greater Orlando
Orange City, Florida, 32763
Revival Clinical Research
Orlando, Florida, 32807
Aspira International
Pasadena, Texas, 77502
LINQ Research LLC
Pearland, Texas, 77584
BRCR Global Clinical Research
Plantation, Florida, 33322
M3 Wake Research, Inc
Raleigh, North Carolina, 27612
Southern Star Research Institute, LLC.
San Antonio, Texas, 78229
Clinical Applications Laboratories Inc
San Diego, California, 92103
Guthrie Medical Group, PC
Sayre, Pennsylvania, 18840
Medrasa Clinical
Sherman, Texas, 75092
Spring Gastroenterology Associates
Spring, Texas, 77379
Texas Gastroenterology Associates
Spring, Texas, 77386
International Center for Research
Tampa, Florida, 33614
Clinical Research Institute of Michigan
Troy, Michigan, 48098
Cedar Valley Medical Specialists, P.C.
Waterloo, Iowa, 50701
Velocity Clinical Research/Gut Whisperer
West Jordan, Utah, 84088
Poland15 sites
Vitamed Galaj i Cichomski Sp.j.
Bydgoszcz, 85-079
Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, 85-794
Centrum Medyczne Lukamed Joanna Luka Wendrowska
Chojnice, 89-600
Centrum Medyczne MBB-MED
Chrzanów, 32-500
Centrum Medyczne CLW-MED Aneta Cichomska, Joanna Luka-Wendrowska
Grudziądz, 86-300
Karkonoskie Centrum Badan Klinicznych Lexmedica Sp. z o.o
Jelenia Góra, 58-500
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów, 95-054
AMICARE Sp. z o.o. sp. k.
Lodz, 91-495
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, 67-100
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302
Uromed Jakub Koteras Twoja Przychodnia- Szczecińskie Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-434
Sonomed Sp. z o.o.
Szczecin, 71-685
Medical Concierge Centrum Medyczne
Warsaw, 02-798
Medical Network Spółka z o.o.
Warsaw, 04-501
Melita Medical Centrum Medyczne
Wroclaw, 50-449
India13 sites
Ahmedabad Bariatrics & Cosmetics Private Limited (Asian Bariatrics)
Ahmedabad, Gujarat, 380015
ICON Hospital
Ahmedabad, Gujarat, 380015
Sanjivani Superspeciality Hospital
Ahmedabad, Gujarat, 380051
SIMS Hospital
Chennai, Tamil Nadu, 600026
Sir Ganga Ram Hospital,
Delhi, National Capital Territory of Delhi, 110060
SMS Medical College & Hospital
Jaipur, Rajasthan, 302004
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital
Mumbai, Maharashtra, 400022
Midas Institute of Gastroenterology
Nagpur, Maharashtra, 440010
Pushpawati Singhania Research Institute
New Delhi, New Delhi, 110017
B.J. Government Medical College and Sassoon General Hospital
Pune, Maharashtra, 411001
Ashwin Medical Foundation Multispeciality Hospital
Pune, Maharashtra, 411033
Gujarat Gastro and Vascular Hospital
Surat, Gujarat, 395009
Acharya Vinoba Bhave Rural Hospital
Wardha, Maharashtra, 442004
Philippines10 sites
Cebu Doctors' University Hospital
Cebu City, 6000
The Medical City Iloilo
Iloilo City, 5000
West Visayas State University Medical Center
Iloilo City, 5000
The Medical City Clark
Mabalacat, 2023
Makati Medical Center
Makati City, 1229
Manila Doctors Hospital
Manila, 1000
The Medical City Ortigas
Pasig, 1605
National Kidney and Transplant Institute
Quezon City, 1101
St. Luke's Medical Center
Quezon City
Cardinal Santos Medical Center (CSMC)
San Juan City, 1502
Vietnam10 sites
103 Military Hospital
Hanoi, 10000
Bach Mai Hospital
Hanoi, 10000
Hanoi Medical University Hospital
Hanoi, 10000
Viet Duc Hospital
Hanoi, 10000
Vinmec Hospital
Hanoi, 10000
115 People's Hospital
Ho Chi Minh City, 70000
Cho Ray Hospital
Ho Chi Minh City, 70000
Gia Dinh People's Hospital
Ho Chi Minh City, 70000
Nguyen Tri Phuong Hospital
Ho Chi Minh City, 70000
Hue Central Hospital
Huế, 49000
Ukraine9 sites
Municipal non-profit enterprise "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov" of Kharkiv City Council
Kharkiv, 61037
Private Enterprise Private Manufacturing Company "Acinus"
Kropyvnytskyi, 25006
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
Comunal NonCommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
Lviv, 79010
Municipal non-profit enterprise "Odesa Regional Clinical Hospital of the Odesa Regional Council", Regional Gastroenterological Center
Odesa, 65025
Ternopil University Hospital
Ternopil, 46002
Municipal non-profit enterprise "M.I. Pyrogov Vinnytsya Regional Clinical Hospital of the Vinnytsya Regional Council"; National Pirogov Memorial Medical University, Vinnytsya
Vinnytsia, 21028
Municipal non-profit enterprise "Vinnytsya City Clinical Hospital №1"; National Pirogov Memorial Medical University, Vinnytsya
Vinnytsia, 21029
Limited Liability Company "Medibor"
Zhytomyr, 10003
Romania8 sites
Spitalul Clinic Colentina
Bucharest, 020125
Spitalul Clinic 'Dr Ion Cantacuzino'
Bucharest, 020475
Clinical Institute Fundeni, Gastro Enterology Department No.2
Bucharest, 022328
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098
Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor" Cluj-Napoca
Cluj-Napoca, 400394
Gastromedical SRL
Iași, 707401
Tirgu-Mures Country Clinical Hospital
Târgu Mureş, 540103
Centrul de Gastroenterologie Dr. Goldis
Timișoara
Jordan7 sites
Al Khalidi Hospital and Medical Center
Amman, 11183
Istishari Hospital
Amman, 11184
The Specialty Hospital Advanced Clinical Center
Amman, 11194
Istiklal Hospital
Amman, 11196
Jordan University Hospital
Amman, 11942
Irbid Specialty Hospital/Clinical Research Center
Irbid, 22110
Pharmaceutical Research Center/Jordan University of Science and Technology
Irbid, 22110
Russia7 sites
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
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
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
LLC 'Polyclinic EXPERT'
Saint Petersburg, 197110
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
State Budgetary Healthcare Institution "Saratov City Clinical Hospital # 5
Saratov, 410071
Regional State Budgetary Institution of Health "Clinical Hospital №1"
Smolensk, 214019
Bulgaria6 sites
Hospital Sveti Panteleimon
Plovdiv, 4000
Medical Center Hipokrat - H
Plovdiv, 4003
LTD Diagnostic Consultative Center 1
Sliven, 8801
Medical Center Excelsior 2
Sofia, 1407
Medical Center Excelsior
Sofia, 1407
University Hospital Tsaritsa Yoanna-ISUL
Sofia, 1527
France6 sites
CHU TOURS. Service d'hépato-Gastro-entérologie
Chambray-lès-Tours, 37170
CHU Lille - Hôpital Claude Huriez
Lille, Cedex, 59037
CHU Montpellier - Hopital Saint Eloi
Montpellier, 34090
Hôpital Lyon Sud - HCL
Pierre-Bénite, 69495
CHU de Saint-Étienne
Saint-Priest-en-Jarez, 42270
Hopital Rangueil
Toulouse, 31059
Saudi Arabia6 sites
National Guard Hospital Jeddah
Jeddah, 21423
King Abdulaziz University Hospital
Jeddah, 21589
Prince Sultan Military Medical City
Riyadh, 11223311159
National Guard Hospital Riyadh
Riyadh, 11426
King Fahad Medical City
Riyadh, 11525
King Khalid University Hospital
Riyadh, 12372
Germany5 sites
Praxis Dr. Michael R. Mross
Berlin, 10318
Studiengesellschaft BSF UG
Halle, 06108
EuGastro GmbH
Leipzig, 04103
Gastro Campus Research GbR
Münster, 48159
Zentrum für Gastroenterologie Saar MVZ GmbH
Saarbrücken, 66111
Italy5 sites
Ospedale: Azienda Policlinico Universitario Bari
Bari, 70124
Università di Cagliari, Dipartimento di Scienze mediche e sanità pubblica
Monserrato, Cagliari, 09042
Università della Campania "Luigi Vanvitelli"
Naples, 80138
Ospedale di Padova
Padova, 35128
A.O. Ordine Mauriziano di Torino
Torino, 10128
Spain5 sites
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, 35010
Hospital La Princesa
Madrid, Madrid, 28006
Hospital Clínico San Carlos and Instituto de Investigación del Hospital Clínico San Carlos (IdISSC)
Madrid, Madrid, 28040
Hospital Virgen de la Salud
Toledo, 45007
Turkey (Türkiye)5 sites
SBÜ. Antalya Eğirim ve Araştırma Hastanesi, Gastroenteroloji
Antalya, 07100
Marmara Universitesi Pendik Eğitim Araştırma Hastanesi, Gastroenteroloji
Istanbul, 34899
Ege Universitesi Tip Fakultesi Hastanesi, Gastroenteroloji
Izmir, 35100
Mersin Universitesi Tip Fakultesi, Gastroenteroloji
Mersin, 33110
Karadeniz Teknik Üniversitesi Tıp Fakütesi Hastanesi Gastroenteroloji
Trabzon, 61080
China4 sites
Alice Ho Miu Ling Nethersole Hospital
Hong Kong
Humanity & Health Clinical Trial Centre
Hong Kong
Queen Mary Hospital
Hong Kong
Tuen Mun Hospital
Hong Kong
Georgia4 sites
JSC,, Vian"
Kutaisi, 4600
LTD "Aversi Clinic"
Tbilisi, 0160
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, 144
LTD "Multi-Profile Clinic Consilium Medulla"
Tbilisi, 186
South Africa4 sites
Worthwhile Clinical Trials
Benoni, Gauteng, 1500
Inspired GI Care
Cape Town, Western Cape, 7800
Wits Clinical Research
Johannesburg, Guauteng, 2193
EMMED
Pretoria, Guauteng, 0002
Denmark3 sites
Aalborg University Hospital
Aalborg, 9000
Hvidovre Hospital
Hvidovre, 2650
Zealand University Hospital, Koge
Køge, 4600
Lebanon3 sites
Saint George Hospital University Medical Center
Beirut, 1100
Dr. Bilal Hotayt Gastroenterology
Beirut, 22411
Hammoud Hospital University Medical Center
Sidon, Sidon, 1600
Moldova2 sites
Institutul de Cardiologie Consultative Department, RTL Clinic
Chisinau, MD 2025
Republican Hospital "Timofei Moșneaga", Consultative Department, Policlinic
Chisinau, MD 2025
Libya1 site
Nini Hospital
Tripoli, Tripoli, 1300
About this study
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
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.
Read the 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 ulcerative colitis of the rectum.
- Conditions
- Ulcerative Proctitis
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicatorCombination product
Also called Twice Daily - Active
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicatorCombination product
Also called Once Daily - Active
Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
Twice daily placebo suppository administered with Sephure applicatorCombination product
Also called Twice Daily - Placebo
Twice daily placebo suppository administered with Sephure applicator
| Study group | Role | What they receive |
|---|---|---|
| Twice Daily - Active | Experimental | Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator Receives: Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator |
| Once Daily - Active | Experimental | Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator Receives: Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator |
| Placebo | Placebo comparator | Twice daily placebo suppository administered with Sephure suppository applicator Receives: Combination Product: Twice daily placebo suppository administered with Sephure applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission
The primary efficacy endpoint was specified as the between-treatment group (HCA Suppository 90 mg bid versus placebo and HCA Suppository 90 mg qd versus placebo) difference in the proportion of subjects with clinical remission at the End of Treatment visit (Day 29). Clinical remission was defined as a Modified Mayo Total Score of 0 to 2, with stool frequency subscore of 0 or 1 (minimum 1 point decrease from baseline), rectal bleeding subscore of 0, and endoscopic subscore of 0 or 1.
Measured: 29 days
Secondary outcomes (2)
Reduction of Stool Frequency
Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency to assess the change in stool frequency from Baseline (Day 1) to End of Treatment (Day 29) and from Baseline (Day 1) to Follow-up (Day 15).
Measured: 29 days
Rectal Bleeding
Rectal Bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to assess the change in rectal bleeding in active treatment groups vs. placebo group from Baseline (Day 1) to End of Treatment (Day 29) and from Baseline (Day 1) to Follow-up (Day 15).
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start10 Dec 2020
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ProctitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristcot HCA LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Davagian, Study director, Cristcot LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469686
- Sponsor's protocol ID
- CHS1221
- Other IDs
- 2019-003596-19, 2019
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2020
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No