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Can a new suppository bring remission to ulcerative proctitis?

NCT ID NCT04469686

Disease control Sponsor: Cristcot HCA LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether a hydrocortisone acetate suppository, given once or twice daily, can safely and effectively treat ulcerative proctitis, a form of ulcerative colitis limited to the rectum. About 200 adults with active disease will receive either the active suppository or a placebo, using a special applicator. The main goal is to see if the treatment can achieve clinical remission, meaning fewer symptoms and improved endoscopic findings, by day 29.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydrocortisone acetate 90 mg suppository
What this could lead to
If successful, this could provide a new, effective treatment option for ulcerative proctitis, potentially helping more people achieve remission with fewer side effects.
What could go wrong
This is a phase 3 trial, but results are not guaranteed. The treatment may not be more effective than placebo, and side effects like rectal irritation or systemic steroid effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

200 people

The number who actually took part.

Started

Dec 2020

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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.

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Conditions

The condition(s) this trial relates to.

ulcerative proctosigmoiditis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative proctitis

Contacts and locations

Locations

  • 103 Military Hospital

    Hanoi, 10000, Vietnam

  • 115 People's Hospital

    Ho Chi Minh City, 70000, Vietnam

  • A.O. Ordine Mauriziano di Torino

    Torino, 10128, Italy

  • AMICARE Sp. z o.o. sp. k.

    Lodz, 91-495, Poland

  • Aalborg University Hospital

    Aalborg, 9000, Denmark

  • Acharya Vinoba Bhave Rural Hospital

    Wardha, Maharashtra, 442004, India

  • Ahmedabad Bariatrics & Cosmetics Private Limited (Asian Bariatrics)

    Ahmedabad, Gujarat, 380015, India

  • Al Khalidi Hospital and Medical Center

    Amman, 11183, Jordan

  • Alice Ho Miu Ling Nethersole Hospital

    Hong Kong, China

  • Allied Digestive Disease Center

    Cypress, Texas, 77429, United States

  • Ashwin Medical Foundation Multispeciality Hospital

    Pune, Maharashtra, 411033, India

  • Aspira International

    Pasadena, Texas, 77502, United States

  • B.J. Government Medical College and Sassoon General Hospital

    Pune, Maharashtra, 411001, India

  • BRCR Global Clinical Research

    Plantation, Florida, 33322, United States

  • Bach Mai Hospital

    Hanoi, 10000, Vietnam

  • CHU Lille - Hôpital Claude Huriez

    Lille, Cedex, 59037, France

  • CHU Montpellier - Hopital Saint Eloi

    Montpellier, 34090, France

  • CHU TOURS. Service d'hépato-Gastro-entérologie

    Chambray-lès-Tours, 37170, France

  • CHU de Saint-Étienne

    Saint-Priest-en-Jarez, 42270, France

  • California Medical Research Associates Inc

    Northridge, California, 91324, United States

  • Cardinal Santos Medical Center (CSMC)

    San Juan City, 1502, Philippines

  • Cebu Doctors' University Hospital

    Cebu City, 6000, Philippines

  • Cedar Valley Medical Specialists, P.C.

    Waterloo, Iowa, 50701, United States

  • Centrul de Gastroenterologie Dr. Goldis

    Timișoara, Romania

  • Centrum Medyczne CLW-MED Aneta Cichomska, Joanna Luka-Wendrowska

    Grudziądz, 86-300, Poland

  • Centrum Medyczne Lukamed Joanna Luka Wendrowska

    Chojnice, 89-600, Poland

  • Centrum Medyczne MBB-MED

    Chrzanów, 32-500, Poland

  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

    Ksawerów, 95-054, Poland

  • Cho Ray Hospital

    Ho Chi Minh City, 70000, Vietnam

  • ClinSearch, LLC

    Chattanooga, Tennessee, 37421, United States

  • Clinical Applications Laboratories Inc

    San Diego, California, 92103, United States

  • Clinical Institute Fundeni, Gastro Enterology Department No.2

    Bucharest, 022328, Romania

  • Clinical Research Associates LLC

    Huntsville, Alabama, 35801, United States

  • Clinical Research Institute of Michigan

    Troy, Michigan, 48098, United States

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047, United States

  • Combined Gastro LLC

    Lafayette, Louisiana, 70503, United States

  • Comprehensive Gastrointestinal Health, LLC

    Northbrook, Illinois, 60062, United States

  • Comunal NonCommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"

    Lviv, 79010, Ukraine

  • Cornell Medical Research

    Newport Beach, California, 92663, United States

  • Digestive Health Associates

    Houston, Texas, 77204, United States

  • Dr. Bilal Hotayt Gastroenterology

    Beirut, 22411, Lebanon

  • Dr. Mouhamad R. Al-Sabbagh

    Houston, Texas, 77043, United States

  • EMMED

    Pretoria, Guauteng, 0002, South Africa

  • Ege Universitesi Tip Fakultesi Hastanesi, Gastroenteroloji

    Izmir, 35100, Turkey (Türkiye)

  • Elixir Research Group

    Houston, Texas, 77077, United States

  • EuGastro GmbH

    Leipzig, 04103, Germany

  • Ezy Medical Research, Co.

    Miami, Florida, 33175, United States

  • 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

  • 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

  • GI PROS Research

    Naples, Florida, 34102, United States

  • Gastro Associates of Greenville

    Greenville, South Carolina, 29607, United States

  • Gastro Campus Research GbR

    Münster, 48159, Germany

  • Gastro Health Research

    Cincinnati, Ohio, 45219, United States

  • Gastro Health Research of Miami

    Miami, Florida, 33176, United States

  • Gastroenterology Associates

    Greenville, South Carolina, 29601, United States

  • Gastroenterology of Greater Orlando

    Orange City, Florida, 32763, United States

  • Gastromedical SRL

    Iași, 707401, Romania

  • Gia Dinh People's Hospital

    Ho Chi Minh City, 70000, Vietnam

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060, United States

  • Gujarat Gastro and Vascular Hospital

    Surat, Gujarat, 395009, India

  • Guthrie Medical Group, PC

    Sayre, Pennsylvania, 18840, United States

  • Hammoud Hospital University Medical Center

    Sidon, Sidon, 1600, Lebanon

  • Hanoi Medical University Hospital

    Hanoi, 10000, Vietnam

  • Homestead Associates in Research

    Miami, Florida, 33032, United States

  • Hopital Rangueil

    Toulouse, 31059, France

  • Hospital Clínico San Carlos and Instituto de Investigación del Hospital Clínico San Carlos (IdISSC)

    Madrid, Madrid, 28040, Spain

  • Hospital Dr. Negrín

    Las Palmas de Gran Canaria, Canary Islands, 35010, Spain

  • Hospital La Princesa

    Madrid, Madrid, 28006, Spain

  • Hospital Sveti Panteleimon

    Plovdiv, 4000, Bulgaria

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942, Spain

  • Hospital Virgen de la Salud

    Toledo, 45007, Spain

  • Hue Central Hospital

    Huế, 49000, Vietnam

  • Humanity & Health Clinical Trial Centre

    Hong Kong, China

  • Hvidovre Hospital

    Hvidovre, 2650, Denmark

  • Hôpital Lyon Sud - HCL

    Pierre-Bénite, 69495, France

  • I.H.S. Health, LLC

    Kissimmee, Florida, 34741, United States

  • ICON Hospital

    Ahmedabad, Gujarat, 380015, India

  • Inspired GI Care

    Cape Town, Western Cape, 7800, South Africa

  • Institutul de Cardiologie Consultative Department, RTL Clinic

    Chisinau, MD 2025, Moldova

  • International Center for Research

    Tampa, Florida, 33614, United States

  • Irbid Specialty Hospital/Clinical Research Center

    Irbid, 22110, Jordan

  • Istiklal Hospital

    Amman, 11196, Jordan

  • Istishari Hospital

    Amman, 11184, Jordan

  • JSC,, Vian"

    Kutaisi, 4600, Georgia

  • Jordan University Hospital

    Amman, 11942, Jordan

  • Karadeniz Teknik Üniversitesi Tıp Fakütesi Hastanesi Gastroenteroloji

    Trabzon, 61080, Turkey (Türkiye)

  • Karkonoskie Centrum Badan Klinicznych Lexmedica Sp. z o.o

    Jelenia Góra, 58-500, Poland

  • King Abdulaziz University Hospital

    Jeddah, 21589, Saudi Arabia

  • King Fahad Medical City

    Riyadh, 11525, Saudi Arabia

  • King Khalid University Hospital

    Riyadh, 12372, Saudi Arabia

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302, Poland

  • LINQ Research LLC

    Pearland, Texas, 77584, United States

  • LLC 'Polyclinic EXPERT'

    Saint Petersburg, 197110, Russia

  • LTD "Aversi Clinic"

    Tbilisi, 0160, Georgia

  • LTD "Multi-Profile Clinic Consilium Medulla"

    Tbilisi, 186, Georgia

  • LTD Diagnostic Consultative Center 1

    Sliven, 8801, Bulgaria

  • Limited Liability Company "Medibor"

    Zhytomyr, 10003, Ukraine

  • Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital

    Mumbai, Maharashtra, 400022, India

  • M3 Wake Research, Inc

    Raleigh, North Carolina, 27612, United States

  • Makati Medical Center

    Makati City, 1229, Philippines

  • Manila Doctors Hospital

    Manila, 1000, Philippines

  • Marmara Universitesi Pendik Eğitim Araştırma Hastanesi, Gastroenteroloji

    Istanbul, 34899, Turkey (Türkiye)

  • Medical Center Excelsior

    Sofia, 1407, Bulgaria

  • Medical Center Excelsior 2

    Sofia, 1407, Bulgaria

  • Medical Center Hipokrat - H

    Plovdiv, 4003, Bulgaria

  • Medical Concierge Centrum Medyczne

    Warsaw, 02-798, Poland

  • Medical Network Spółka z o.o.

    Warsaw, 04-501, Poland

  • Medrasa Clinical

    Sherman, Texas, 75092, United States

  • Melita Medical Centrum Medyczne

    Wroclaw, 50-449, Poland

  • Mersin Universitesi Tip Fakultesi, Gastroenteroloji

    Mersin, 33110, Turkey (Türkiye)

  • Midas Institute of Gastroenterology

    Nagpur, Maharashtra, 440010, India

  • Municipal non-profit enterprise "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov" of Kharkiv City Council

    Kharkiv, 61037, 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

  • 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 "Odesa Regional Clinical Hospital of the Odesa Regional Council", Regional Gastroenterological Center

    Odesa, 65025, Ukraine

  • Municipal non-profit enterprise "Vinnytsya City Clinical Hospital №1"; National Pirogov Memorial Medical University, Vinnytsya

    Vinnytsia, 21029, Ukraine

  • National Guard Hospital Jeddah

    Jeddah, 21423, Saudi Arabia

  • National Guard Hospital Riyadh

    Riyadh, 11426, Saudi Arabia

  • National Kidney and Transplant Institute

    Quezon City, 1101, Philippines

  • NexGen Research

    Lima, Ohio, 45805, United States

  • Nguyen Tri Phuong Hospital

    Ho Chi Minh City, 70000, Vietnam

  • Nini Hospital

    Tripoli, Tripoli, 1300, Libya

  • Om Research

    Apple Valley, California, 92307, United States

  • Om Research

    Camarillo, California, 93012, United States

  • Om Research

    Lancaster, California, 93534, United States

  • One Health Research Clinic Atlanta

    Johns Creek, Georgia, 30097, United States

  • Ospedale di Padova

    Padova, 35128, Italy

  • Ospedale: Azienda Policlinico Universitario Bari

    Bari, 70124, Italy

  • Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Malgorzata Trzaska

    Bydgoszcz, 85-794, Poland

  • Peters Medical Research

    High Point, North Carolina, 27260, United States

  • Pharmaceutical Research Center/Jordan University of Science and Technology

    Irbid, 22110, Jordan

  • Praxis Dr. Michael R. Mross

    Berlin, 10318, Germany

  • Precision Research

    El Cajon, California, 92020, United States

  • Prince Sultan Military Medical City

    Riyadh, 11223311159, Saudi Arabia

  • Private Enterprise Private Manufacturing Company "Acinus"

    Kropyvnytskyi, 25006, Ukraine

  • Pushpawati Singhania Research Institute

    New Delhi, New Delhi, 110017, India

  • Queen Mary Hospital

    Hong Kong, China

  • Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor" Cluj-Napoca

    Cluj-Napoca, 400394, Romania

  • Regional State Budgetary Institution of Health "Clinical Hospital №1"

    Smolensk, 214019, Russia

  • Rejuvaline Medical Research

    Miami, Florida, 33155, United States

  • Republican Hospital "Timofei Moșneaga", Consultative Department, Policlinic

    Chisinau, MD 2025, Moldova

  • Revival Clinical Research

    Orlando, Florida, 32807, United States

  • Revive Research Institute

    Farmington Hills, Michigan, 48334, United States

  • 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

  • SBÜ. Antalya Eğirim ve Araştırma Hastanesi, Gastroenteroloji

    Antalya, 07100, Turkey (Türkiye)

  • SIMS Hospital

    Chennai, Tamil Nadu, 600026, India

  • SMS Medical College & Hospital

    Jaipur, Rajasthan, 302004, India

  • Saint George Hospital University Medical Center

    Beirut, 1100, Lebanon

  • Sanjivani Superspeciality Hospital

    Ahmedabad, Gujarat, 380051, India

  • Sanmora Bespoke Clinical Research Solutions, LLC.

    East Orange, New Jersey, 07018, United States

  • Sir Ganga Ram Hospital,

    Delhi, National Capital Territory of Delhi, 110060, India

  • Sonomed Sp. z o.o.

    Szczecin, 71-685, Poland

  • Southern CA Research Institute Medical Group/W Gastroenterology Medical Group

    Los Angeles, California, 90045, United States

  • Southern Star Research Institute, LLC.

    San Antonio, Texas, 78229, United States

  • Spitalul Clinic 'Dr Ion Cantacuzino'

    Bucharest, 020475, Romania

  • Spitalul Clinic Colentina

    Bucharest, 020125, Romania

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098, Romania

  • Spring Gastroenterology Associates

    Spring, Texas, 77379, United States

  • St. Luke's Medical Center

    Quezon City, Philippines

  • State Budgetary Healthcare Institution "Saratov City Clinical Hospital # 5

    Saratov, 410071, Russia

  • Studiengesellschaft BSF UG

    Halle, 06108, Germany

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania, 17110, United States

  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

    Tbilisi, 144, Georgia

  • Ternopil University Hospital

    Ternopil, 46002, Ukraine

  • Texas Gastroenterology Associates

    Spring, Texas, 77386, United States

  • The Medical City Clark

    Mabalacat, 2023, Philippines

  • The Medical City Iloilo

    Iloilo City, 5000, Philippines

  • The Medical City Ortigas

    Pasig, 1605, Philippines

  • The Specialty Hospital Advanced Clinical Center

    Amman, 11194, Jordan

  • Tirgu-Mures Country Clinical Hospital

    Târgu Mureş, 540103, Romania

  • Tri-Cities Gastroenterology

    Kingsport, Tennessee, 37663, United States

  • Tuen Mun Hospital

    Hong Kong, China

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, Lubusz Voivodeship, 67-100, Poland

  • US Associates In Research

    Miami, Florida, 33175, United States

  • University Hospital Tsaritsa Yoanna-ISUL

    Sofia, 1527, Bulgaria

  • Università della Campania "Luigi Vanvitelli"

    Naples, 80138, Italy

  • Università di Cagliari, Dipartimento di Scienze mediche e sanità pubblica

    Monserrato, Cagliari, 09042, Italy

  • Uromed Jakub Koteras Twoja Przychodnia- Szczecińskie Centrum Medyczne

    Szczecin, West Pomeranian Voivodeship, 71-434, Poland

  • Velocity Clinical Research/Gut Whisperer

    West Jordan, Utah, 84088, United States

  • Viet Duc Hospital

    Hanoi, 10000, Vietnam

  • Vinmec Hospital

    Hanoi, 10000, Vietnam

  • Vitamed Galaj i Cichomski Sp.j.

    Bydgoszcz, 85-079, Poland

  • West Visayas State University Medical Center

    Iloilo City, 5000, Philippines

  • Westchester Putnam Gastro

    Carmel, New York, 10512, United States

  • Wits Clinical Research

    Johannesburg, Guauteng, 2193, South Africa

  • Worthwhile Clinical Trials

    Benoni, Gauteng, 1500, South Africa

  • Zealand University Hospital, Koge

    Køge, 4600, Denmark

  • Zentrum für Gastroenterologie Saar MVZ GmbH

    Saarbrücken, 66111, Germany