Can a new suppository bring remission to ulcerative proctitis?
NCT ID NCT04469686
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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103 Military Hospital
Hanoi, 10000, Vietnam
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115 People's Hospital
Ho Chi Minh City, 70000, Vietnam
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A.O. Ordine Mauriziano di Torino
Torino, 10128, Italy
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AMICARE Sp. z o.o. sp. k.
Lodz, 91-495, Poland
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Aalborg University Hospital
Aalborg, 9000, Denmark
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Acharya Vinoba Bhave Rural Hospital
Wardha, Maharashtra, 442004, India
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Ahmedabad Bariatrics & Cosmetics Private Limited (Asian Bariatrics)
Ahmedabad, Gujarat, 380015, India
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Al Khalidi Hospital and Medical Center
Amman, 11183, Jordan
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Alice Ho Miu Ling Nethersole Hospital
Hong Kong, China
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Allied Digestive Disease Center
Cypress, Texas, 77429, United States
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Ashwin Medical Foundation Multispeciality Hospital
Pune, Maharashtra, 411033, India
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Aspira International
Pasadena, Texas, 77502, United States
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B.J. Government Medical College and Sassoon General Hospital
Pune, Maharashtra, 411001, India
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BRCR Global Clinical Research
Plantation, Florida, 33322, United States
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Bach Mai Hospital
Hanoi, 10000, Vietnam
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CHU Lille - Hôpital Claude Huriez
Lille, Cedex, 59037, France
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CHU Montpellier - Hopital Saint Eloi
Montpellier, 34090, France
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CHU TOURS. Service d'hépato-Gastro-entérologie
Chambray-lès-Tours, 37170, France
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CHU de Saint-Étienne
Saint-Priest-en-Jarez, 42270, France
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California Medical Research Associates Inc
Northridge, California, 91324, United States
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Cardinal Santos Medical Center (CSMC)
San Juan City, 1502, Philippines
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Cebu Doctors' University Hospital
Cebu City, 6000, Philippines
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Cedar Valley Medical Specialists, P.C.
Waterloo, Iowa, 50701, United States
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Centrul de Gastroenterologie Dr. Goldis
Timișoara, Romania
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Centrum Medyczne CLW-MED Aneta Cichomska, Joanna Luka-Wendrowska
Grudziądz, 86-300, Poland
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Centrum Medyczne Lukamed Joanna Luka Wendrowska
Chojnice, 89-600, Poland
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Centrum Medyczne MBB-MED
Chrzanów, 32-500, Poland
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Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów, 95-054, Poland
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Cho Ray Hospital
Ho Chi Minh City, 70000, Vietnam
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ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
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Clinical Applications Laboratories Inc
San Diego, California, 92103, United States
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Clinical Institute Fundeni, Gastro Enterology Department No.2
Bucharest, 022328, Romania
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Clinical Research Associates LLC
Huntsville, Alabama, 35801, United States
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Clinical Research Institute of Michigan
Troy, Michigan, 48098, United States
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Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
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Combined Gastro LLC
Lafayette, Louisiana, 70503, United States
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Comprehensive Gastrointestinal Health, LLC
Northbrook, Illinois, 60062, United States
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Comunal NonCommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
Lviv, 79010, Ukraine
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Cornell Medical Research
Newport Beach, California, 92663, United States
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Digestive Health Associates
Houston, Texas, 77204, United States
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Dr. Bilal Hotayt Gastroenterology
Beirut, 22411, Lebanon
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Dr. Mouhamad R. Al-Sabbagh
Houston, Texas, 77043, United States
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EMMED
Pretoria, Guauteng, 0002, South Africa
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Ege Universitesi Tip Fakultesi Hastanesi, Gastroenteroloji
Izmir, 35100, Turkey (Türkiye)
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Elixir Research Group
Houston, Texas, 77077, United States
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EuGastro GmbH
Leipzig, 04103, Germany
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Ezy Medical Research, Co.
Miami, Florida, 33175, United States
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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
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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
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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
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GI PROS Research
Naples, Florida, 34102, United States
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Gastro Associates of Greenville
Greenville, South Carolina, 29607, United States
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Gastro Campus Research GbR
Münster, 48159, Germany
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Gastro Health Research
Cincinnati, Ohio, 45219, United States
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Gastro Health Research of Miami
Miami, Florida, 33176, United States
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Gastroenterology Associates
Greenville, South Carolina, 29601, United States
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Gastroenterology of Greater Orlando
Orange City, Florida, 32763, United States
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Gastromedical SRL
Iași, 707401, Romania
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Gia Dinh People's Hospital
Ho Chi Minh City, 70000, Vietnam
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Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
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Gujarat Gastro and Vascular Hospital
Surat, Gujarat, 395009, India
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Guthrie Medical Group, PC
Sayre, Pennsylvania, 18840, United States
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Hammoud Hospital University Medical Center
Sidon, Sidon, 1600, Lebanon
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Hanoi Medical University Hospital
Hanoi, 10000, Vietnam
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Homestead Associates in Research
Miami, Florida, 33032, United States
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Hopital Rangueil
Toulouse, 31059, France
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Hospital Clínico San Carlos and Instituto de Investigación del Hospital Clínico San Carlos (IdISSC)
Madrid, Madrid, 28040, Spain
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Hospital Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, 35010, Spain
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Hospital La Princesa
Madrid, Madrid, 28006, Spain
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Hospital Sveti Panteleimon
Plovdiv, 4000, Bulgaria
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Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
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Hospital Virgen de la Salud
Toledo, 45007, Spain
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Hue Central Hospital
Huế, 49000, Vietnam
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Humanity & Health Clinical Trial Centre
Hong Kong, China
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Hvidovre Hospital
Hvidovre, 2650, Denmark
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Hôpital Lyon Sud - HCL
Pierre-Bénite, 69495, France
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I.H.S. Health, LLC
Kissimmee, Florida, 34741, United States
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ICON Hospital
Ahmedabad, Gujarat, 380015, India
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Inspired GI Care
Cape Town, Western Cape, 7800, South Africa
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Institutul de Cardiologie Consultative Department, RTL Clinic
Chisinau, MD 2025, Moldova
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International Center for Research
Tampa, Florida, 33614, United States
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Irbid Specialty Hospital/Clinical Research Center
Irbid, 22110, Jordan
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Istiklal Hospital
Amman, 11196, Jordan
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Istishari Hospital
Amman, 11184, Jordan
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JSC,, Vian"
Kutaisi, 4600, Georgia
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Jordan University Hospital
Amman, 11942, Jordan
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Karadeniz Teknik Üniversitesi Tıp Fakütesi Hastanesi Gastroenteroloji
Trabzon, 61080, Turkey (Türkiye)
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Karkonoskie Centrum Badan Klinicznych Lexmedica Sp. z o.o
Jelenia Góra, 58-500, Poland
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King Abdulaziz University Hospital
Jeddah, 21589, Saudi Arabia
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King Fahad Medical City
Riyadh, 11525, Saudi Arabia
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King Khalid University Hospital
Riyadh, 12372, Saudi Arabia
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Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302, Poland
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LINQ Research LLC
Pearland, Texas, 77584, United States
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LLC 'Polyclinic EXPERT'
Saint Petersburg, 197110, Russia
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LTD "Aversi Clinic"
Tbilisi, 0160, Georgia
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LTD "Multi-Profile Clinic Consilium Medulla"
Tbilisi, 186, Georgia
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LTD Diagnostic Consultative Center 1
Sliven, 8801, Bulgaria
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Limited Liability Company "Medibor"
Zhytomyr, 10003, Ukraine
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Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital
Mumbai, Maharashtra, 400022, India
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M3 Wake Research, Inc
Raleigh, North Carolina, 27612, United States
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Makati Medical Center
Makati City, 1229, Philippines
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Manila Doctors Hospital
Manila, 1000, Philippines
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Marmara Universitesi Pendik Eğitim Araştırma Hastanesi, Gastroenteroloji
Istanbul, 34899, Turkey (Türkiye)
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Medical Center Excelsior
Sofia, 1407, Bulgaria
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Medical Center Excelsior 2
Sofia, 1407, Bulgaria
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Medical Center Hipokrat - H
Plovdiv, 4003, Bulgaria
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Medical Concierge Centrum Medyczne
Warsaw, 02-798, Poland
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Medical Network Spółka z o.o.
Warsaw, 04-501, Poland
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Medrasa Clinical
Sherman, Texas, 75092, United States
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Melita Medical Centrum Medyczne
Wroclaw, 50-449, Poland
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Mersin Universitesi Tip Fakultesi, Gastroenteroloji
Mersin, 33110, Turkey (Türkiye)
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Midas Institute of Gastroenterology
Nagpur, Maharashtra, 440010, India
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Municipal non-profit enterprise "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov" of Kharkiv City Council
Kharkiv, 61037, Ukraine
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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
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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
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Municipal non-profit enterprise "Odesa Regional Clinical Hospital of the Odesa Regional Council", Regional Gastroenterological Center
Odesa, 65025, Ukraine
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Municipal non-profit enterprise "Vinnytsya City Clinical Hospital №1"; National Pirogov Memorial Medical University, Vinnytsya
Vinnytsia, 21029, Ukraine
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National Guard Hospital Jeddah
Jeddah, 21423, Saudi Arabia
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National Guard Hospital Riyadh
Riyadh, 11426, Saudi Arabia
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National Kidney and Transplant Institute
Quezon City, 1101, Philippines
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NexGen Research
Lima, Ohio, 45805, United States
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Nguyen Tri Phuong Hospital
Ho Chi Minh City, 70000, Vietnam
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Nini Hospital
Tripoli, Tripoli, 1300, Libya
-
Om Research
Apple Valley, California, 92307, United States
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Om Research
Camarillo, California, 93012, United States
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Om Research
Lancaster, California, 93534, United States
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One Health Research Clinic Atlanta
Johns Creek, Georgia, 30097, United States
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Ospedale di Padova
Padova, 35128, Italy
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Ospedale: Azienda Policlinico Universitario Bari
Bari, 70124, Italy
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Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, 85-794, Poland
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Peters Medical Research
High Point, North Carolina, 27260, United States
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Pharmaceutical Research Center/Jordan University of Science and Technology
Irbid, 22110, Jordan
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Praxis Dr. Michael R. Mross
Berlin, 10318, Germany
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Precision Research
El Cajon, California, 92020, United States
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Prince Sultan Military Medical City
Riyadh, 11223311159, Saudi Arabia
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Private Enterprise Private Manufacturing Company "Acinus"
Kropyvnytskyi, 25006, Ukraine
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Pushpawati Singhania Research Institute
New Delhi, New Delhi, 110017, India
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Queen Mary Hospital
Hong Kong, China
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Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor" Cluj-Napoca
Cluj-Napoca, 400394, Romania
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Regional State Budgetary Institution of Health "Clinical Hospital №1"
Smolensk, 214019, Russia
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Rejuvaline Medical Research
Miami, Florida, 33155, United States
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Republican Hospital "Timofei Moșneaga", Consultative Department, Policlinic
Chisinau, MD 2025, Moldova
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Revival Clinical Research
Orlando, Florida, 32807, United States
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Revive Research Institute
Farmington Hills, Michigan, 48334, United States
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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
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SBÜ. Antalya Eğirim ve Araştırma Hastanesi, Gastroenteroloji
Antalya, 07100, Turkey (Türkiye)
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SIMS Hospital
Chennai, Tamil Nadu, 600026, India
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SMS Medical College & Hospital
Jaipur, Rajasthan, 302004, India
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Saint George Hospital University Medical Center
Beirut, 1100, Lebanon
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Sanjivani Superspeciality Hospital
Ahmedabad, Gujarat, 380051, India
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Sanmora Bespoke Clinical Research Solutions, LLC.
East Orange, New Jersey, 07018, United States
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Sir Ganga Ram Hospital,
Delhi, National Capital Territory of Delhi, 110060, India
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Sonomed Sp. z o.o.
Szczecin, 71-685, Poland
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Southern CA Research Institute Medical Group/W Gastroenterology Medical Group
Los Angeles, California, 90045, United States
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Southern Star Research Institute, LLC.
San Antonio, Texas, 78229, United States
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Spitalul Clinic 'Dr Ion Cantacuzino'
Bucharest, 020475, Romania
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Spitalul Clinic Colentina
Bucharest, 020125, Romania
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Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098, Romania
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Spring Gastroenterology Associates
Spring, Texas, 77379, United States
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St. Luke's Medical Center
Quezon City, Philippines
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State Budgetary Healthcare Institution "Saratov City Clinical Hospital # 5
Saratov, 410071, Russia
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Studiengesellschaft BSF UG
Halle, 06108, Germany
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Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, 17110, United States
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Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, 144, Georgia
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Ternopil University Hospital
Ternopil, 46002, Ukraine
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Texas Gastroenterology Associates
Spring, Texas, 77386, United States
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The Medical City Clark
Mabalacat, 2023, Philippines
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The Medical City Iloilo
Iloilo City, 5000, Philippines
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The Medical City Ortigas
Pasig, 1605, Philippines
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The Specialty Hospital Advanced Clinical Center
Amman, 11194, Jordan
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Tirgu-Mures Country Clinical Hospital
Târgu Mureş, 540103, Romania
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Tri-Cities Gastroenterology
Kingsport, Tennessee, 37663, United States
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Tuen Mun Hospital
Hong Kong, China
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Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
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US Associates In Research
Miami, Florida, 33175, United States
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University Hospital Tsaritsa Yoanna-ISUL
Sofia, 1527, Bulgaria
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Università della Campania "Luigi Vanvitelli"
Naples, 80138, Italy
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Università di Cagliari, Dipartimento di Scienze mediche e sanità pubblica
Monserrato, Cagliari, 09042, Italy
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Uromed Jakub Koteras Twoja Przychodnia- Szczecińskie Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
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Velocity Clinical Research/Gut Whisperer
West Jordan, Utah, 84088, United States
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Viet Duc Hospital
Hanoi, 10000, Vietnam
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Vinmec Hospital
Hanoi, 10000, Vietnam
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Vitamed Galaj i Cichomski Sp.j.
Bydgoszcz, 85-079, Poland
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West Visayas State University Medical Center
Iloilo City, 5000, Philippines
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Westchester Putnam Gastro
Carmel, New York, 10512, United States
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Wits Clinical Research
Johannesburg, Guauteng, 2193, South Africa
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Worthwhile Clinical Trials
Benoni, Gauteng, 1500, South Africa
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Zealand University Hospital, Koge
Køge, 4600, Denmark
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Zentrum für Gastroenterologie Saar MVZ GmbH
Saarbrücken, 66111, Germany