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NCT05528510Active, not recruitingPhase 3

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
418 (actual)
First submitted
19 Aug 2022
Start date
13 Sept 2022
Primary completion date
2 Apr 2024
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05528510
EU CT number
2023-504719-34-00
EudraCT number
2022-000365-41

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 418
  • From 13 Sept 2022 to the primary completion date, 2 Apr 2024
  • 210 sites in 25 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
  • Receiving prohibited medications and treatments

Other illness

  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
  • Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection

Other

  • UC limited to the rectum only

Who the study is looking for

  • Signed informed consent form
  • 18 years of age or older
  • Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
  • Moderately to severely active UC as per the modified Mayo score
  • Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (210)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cer Instituto Medico
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Buenos AiresArgentinaUnknown status
Hospital General de Agudos José Maria Ramos Mejía
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Buenos AiresArgentinaUnknown status
Clinica Adventista Belgrano
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Ciudad de Buenos AiresArgentinaUnknown status
Sanatorio Duarte Quiroz
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CórdobaArgentinaUnknown status
Hospital Privado Universitario de Córdoba
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CórdobaArgentinaUnknown status
Hospital Italiano de La Plata
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La PlataArgentinaUnknown status
Centro de Investigaciones Medicas Mar Del Plata
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Mar del PlataArgentinaUnknown status
Hospital Provincial del Centenario
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RosarioArgentinaUnknown status
Royal Adelaide Hospital
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AdelaideAustraliaUnknown status
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
Monash Health
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ClaytonAustraliaUnknown status
Royal Brisbane and Women's Hospital
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HerstonAustraliaUnknown status
Fiona Stanley Hospital
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MurdochAustraliaUnknown status
Royal Melbourne Hospital
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ParkvilleAustraliaUnknown status
IBD Clinical Trials Mater Research
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South BrisbaneAustraliaUnknown status
The Queen Elizabeth Hospital
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Woodville SouthAustraliaUnknown status
Princess Alexandra Hospital
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WoolloongabbaAustraliaUnknown status
CHU Saint-Pierre
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BrusselsBelgiumActive, not recruiting
Medical center Asclepion humane medicine researches EOOD
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SofiaBulgariaActive, not recruiting
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaActive, not recruiting
Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu
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BotucatuBrazilUnknown status
L2IP - Instituto de Pesquisas Clínicas
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BrasíliaBrazilUnknown status
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
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CampinasBrazilUnknown status
CDC - Centro Digestivo de Curitiba
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CuritibaBrazilUnknown status
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
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JaúBrazilUnknown status
Galileo Medical Research Ltda.
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Juiz de ForaBrazilUnknown status
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilUnknown status
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Porto AlegreBrazilUnknown status
CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao
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SalvadorBrazilUnknown status
Pesquisare Saude
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Santo AndréBrazilUnknown status
Kaiser Hospta
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São José do Rio PretoBrazilUnknown status
IDOR - Regional Sao Paulo
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São PauloBrazilUnknown status
BR Trials - Ensaios Clínicos e Consultoria Ltda.
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São PauloBrazilUnknown status
Integral Pesquisa e Ensino
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VotuporangaBrazilUnknown status
Barrie GI Associates
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BarrieCanadaUnknown status
Fraser Clinical Trials, Inc.
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New WestminsterCanadaUnknown status
Royal University Hospital
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SaskatoonCanadaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
China-Japan Friendship Hospital
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BeijingChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Chongqing General Hospital
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ChongqingChinaUnknown status
First Affiliated Hospital Of Gannan Medical University
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GanzhouChinaUnknown status
Zhujiang Hospital of Southern Medical University
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GuangzhouChinaUnknown status
The second Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University College of Medicine
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HangzhouChinaUnknown status
The Second Affiliated Hospital of Zhejiang University College of Medicine
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HangzhouChinaUnknown status
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
Jinhua Municipal Central Hospital
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JinhuaChinaUnknown status
Lanzhou University Second Hospital
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LanzhouChinaUnknown status
The First Affiliated Hospital of Henan University of Science and Technology
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LuoyangChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
Zhongda Hospital Southeast University
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NanjingChinaUnknown status
Shanghai East Hospital
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ShanghaiChinaUnknown status
Ruijin Hospital Shanghai Jiao Tong University
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
Shenzhen Hospital of Southern Medical University
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ShenzhenChinaUnknown status
The Second Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Taihe Hospital
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ShiyanChinaUnknown status
Renmin Hospital of Wuhan University
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WuhanChinaUnknown status
Wuxi People's Hospital
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WuxiChinaUnknown status
General Hospital of Ningxia Medical Hospital
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YinchuanChinaUnknown status
The Second Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Nemocnice České Budějovice, a.s.
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České BudějoviceCzechiaActive, not recruiting
Gastroenterologie s.r.o.
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Hradec KrálovéCzechiaActive, not recruiting
Axon Clinical s.r.o.
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Prague 5CzechiaActive, not recruiting
Medizinisches Versorgungszentrum (MVZ) Dachau
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DachauGermanyActive, not recruiting
Medizinische Hochschule Hannover
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HanoverGermanyActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Hospital Marina Baixa De La Vila Joiosa
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VillajoyosaSpainActive, not recruiting
Centre Medico Chirurgical Ambroise Pare Hartmann
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Neuilly-Sur-SeineFranceActive, not recruiting
Nouvelles Cliniques Nimoises
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NimesFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
CHRU De Nancy
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Vandoeuvre Les NancyFranceActive, not recruiting
Semmelweis University
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BudapestHungaryActive, not recruiting
Semmelweis University
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Budapest VIIIHungaryActive, not recruiting
Vasutegeszseguegyi Nonprofit Koezhasznu Kft.
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DebrecenHungaryActive, not recruiting
Ha'Emek Medical Center
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AfulaIsraelUnknown status
Bnai Zion Medical Center
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HaifaIsraelUnknown status
Wolfson Medical Center
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HolonIsraelUnknown status
Shaare Zedek Medical Center - Jerusalem, ISRAEL
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JerusalemIsraelUnknown status
Lev Talpiot Clinic
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JerusalemIsraelUnknown status
Galilee Medical Center
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NahariyaIsraelUnknown status
Chaim Sheba Medical Center
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Ramat GanIsraelUnknown status
Fortis Memorial Research Institute
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GurugramIndiaUnknown status
Asian Institute Of Gastroenterology
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HyderabadIndiaUnknown status
Kasturba Medical College Hospital
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ManipalIndiaUnknown status
P D Hinduja National Hospital and Medical Research Center
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MumbaiIndiaUnknown status
SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
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SuratIndiaUnknown status
Jordan University Hospital
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AmmanJordanUnknown status
The Speciality Hospital (TSH) / Advanced Clinical Center
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AmmanJordanUnknown status
Irbid Specialty Hospital
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AydounJordanUnknown status
King Abdullah University Hospital
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IrbidJordanUnknown status
Tokyo Medical and Dental University Hospital
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Bunkyō CityJapanUnknown status
Ginza central clinic
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ChūōkuJapanUnknown status
Sai Gastroenterology Proctology
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Fujiidera-shiJapanUnknown status
Fukuoka University Hospital
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FukuokaJapanUnknown status
Fukushima Medical University Hospital
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FukushimaJapanUnknown status
Hachinohe City Hospital
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HachinoheJapanUnknown status
Tokai University Hachioji Hospital
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HachiōjiJapanUnknown status
Matsuda Hospital
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HamamatsuJapanUnknown status
National Hospital Organization Mito Medical Center
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Higashiibaraki-gunJapanUnknown status
Kagoshima University Hospital
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KagoshimaJapanUnknown status
Kagoshima IBD Gastroenterology Clinic
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KagoshimaJapanUnknown status
National Hospital Organization Kanazawa Medical Center
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KanazawaJapanUnknown status
Tsujinaka Hospital Kashiwanoha
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KashiwaJapanUnknown status
Kyushu Rosai Hospital
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KitakyushuJapanUnknown status
Kumagaya General Hospital
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Kumagaya-shiJapanUnknown status
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
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KureJapanUnknown status
Tokushukai Chiba-Nishi General Hospital
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MatsudoJapanUnknown status
National Hospital Organization Matsumoto Medical Center
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MatsumotoJapanUnknown status
Yokoyama IBD Clinic
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NagoyaJapanUnknown status
Oita Red Cross Hospital
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ŌitaJapanUnknown status
Ishida Clinic of IBD and Gastroenterology
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ŌitaJapanUnknown status
Okayama Saiseikai General Hospital
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OkayamaJapanUnknown status
Kinshukai Infusion Clinic
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OsakaJapanUnknown status
Japanese Red Cross Osaka Hospital
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OsakaJapanUnknown status
Kindai University Hospital
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Ōsaka-sayamaJapanUnknown status
Dokkyo Medical University Hospital
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Shimotsuga-gunJapanUnknown status
Center Hospital of the National Center for Global Health and Medicine
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Shinjuku-KuJapanUnknown status
Tokyo Metropolitan Bokutoh Hospital
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Sumida-kuJapanUnknown status
National Hospital Organization Shizuoka Medical Center
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Sunto-gunJapanUnknown status
Juntendo University Hospital Urayasu
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UrayasuJapanUnknown status
Kanke Gastrointestinal Clinic
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UtsunomiyaJapanUnknown status
Yokohama City University Medical Center
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YokohamaJapanUnknown status
Inje University Haeundae Paik Hospital
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BusanSouth KoreaUnknown status
Yeungnam University Hospital
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DaeguSouth KoreaUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
Chosun University Hospital
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GwangjuSouth KoreaUnknown status
Korea University Ansan Hospital
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Gyeonggi-doSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Chung ang University Hospital
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SeoulSouth KoreaUnknown status
Kyung Hee University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea St. Vincent's Hospital
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SuwonSouth KoreaUnknown status
SCIENTIA Investigacion Clinica SC
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Chihuahua CityMexicoUnknown status
Clinica de Investigacion en Reumatologia y Obesidad
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GuadalajaraMexicoUnknown status
Medical Care & Research Sa de Cv
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MéridaMexicoUnknown status
Clinicos Asociados BOCM SC
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Mexico CityMexicoUnknown status
Centro de Investigación Clinica Acelerada, S.C.
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Mexico CityMexicoUnknown status
Hospital Medica Sur Tlalpan
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Mexico CityMexicoUnknown status
Centro Regiomontano de Estudios Clínicos Roma S.C.
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MonterreyMexicoUnknown status
Fundacion Santos Y De La Garza Evia IBP
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MonterreyMexicoUnknown status
Clinical Research Institute Saltillo S.A. de C.V.
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SaltilloMexicoUnknown status
Oncare
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San Pedro Garza GarcíaMexicoUnknown status
Hospital Selayang
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Batu CavesMalaysiaUnknown status
Hospital Pulau Pinang
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George TownMalaysiaUnknown status
Hospital Sultanah Aminah
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Johor BahruMalaysiaUnknown status
University Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Hospital Umum Sarawak
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KuchingMalaysiaUnknown status
Hospital Tuanku Jaafar
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SerembanMalaysiaUnknown status
Hutt Hospital
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BoulcottNew ZealandUnknown status
Christchurch Hospital
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ChristchurchNew ZealandUnknown status
Dunedin Hospital
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DunedinNew ZealandUnknown status
Auckland City Hospital
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GraftonNew ZealandUnknown status
Waikato Hospital
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HamiltonNew ZealandUnknown status
Gastromed Kralisz Romatowski Stachurska Sp. j.
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BialystokPolandActive, not recruiting
Centrum Medyczne Lukamed Sp z o o
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ChojnicePolandActive, not recruiting
Promed P.Lach R.Glowacki Sp. j.
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CracowPolandActive, not recruiting
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
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CracowPolandActive, not recruiting
Centrum Medyczne Medyk Sp. z o.o. S.K.
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RzeszowPolandActive, not recruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
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SzczecinPolandActive, not recruiting
GASTROMED Sp. z o.o.
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TorunPolandActive, not recruiting
Medical Network Sp z o o
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WarsawPolandActive, not recruiting
Bodyclinic sp. z o.o. sp.k.
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WarsawPolandActive, not recruiting
Melita Medical Sp. z o.o.
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WroclawPolandActive, not recruiting
Vistamed & Vertigo Sp Z O O
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WroclawPolandActive, not recruiting
Pro Life Medica Sp. z o.o.
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ZamośćPolandActive, not recruiting
Cliniq s.r.o.
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BratislavaSlovakiaCompleted
ENDOMED, s.r.o.
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KošiceSlovakiaCompleted
China Medical University Hospital
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TaichungTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
MacKay Memorial Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Om Research LLC 1
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Apple ValleyUnited StatesUnknown status
Digestive Healthcare of Georgia, P.C
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AtlantaUnited StatesUnknown status
Atlanta Gastroenterology Associates
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AtlantaUnited StatesUnknown status
University of North Carolina
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Chapel HillUnited StatesUnknown status
Gastroenterology Associates of Tidewater
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ChesapeakeUnited StatesUnknown status
Clinical Research Institute of Michigan, LLC
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ChesterfieldUnited StatesUnknown status
Gastro Florida
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ClearwaterUnited StatesUnknown status
Peak Gastroenterology Associates
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Colorado SpringsUnited StatesUnknown status
Dayton Gastroenterology, Inc
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DaytonUnited StatesUnknown status
Detroit Clinical Research Center
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Farmington HillsUnited StatesUnknown status
Peters Medical Research
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High PointUnited StatesUnknown status
Smart Medical Research
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HollisUnited StatesUnknown status
I.H.S Health, LLC
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KissimmeeUnited StatesUnknown status
Om Research LLC
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LancasterUnited StatesUnknown status
Research Solutions of Arizona
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Litchfield ParkUnited StatesUnknown status
Gastroenterology Associates of Central GA
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MaconUnited StatesUnknown status
Columbus Clinical Services LLC
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MiamiUnited StatesUnknown status
Vista Health Research, LLC
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MiamiUnited StatesUnknown status
Care Access Research, Ogden
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OgdenUnited StatesUnknown status
Gastroenterology Associates of Orangeburg, SC
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OrangeburgUnited StatesUnknown status
Orlando Health
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OrlandoUnited StatesUnknown status
Allegheny General Hospital of Research
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PittsburghUnited StatesUnknown status
Gastroenterology Associates
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Salt Lake CityUnited StatesUnknown status
Ut Health Science Center At San Antonio
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San AntonioUnited StatesUnknown status
Southern Star Research Institute, LLC
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San AntonioUnited StatesUnknown status
Medical Associates Research Group, Inc.
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San DiegoUnited StatesUnknown status
Theia Clincial Research, LLC
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Temple TerraceUnited StatesUnknown status
Cotton O'Neil Digestive Health Center
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TopekaUnited StatesUnknown status
Tyler Research Institute, LLC
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TylerUnited StatesUnknown status
Frontier Clinical Research
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UniontownUnited StatesUnknown status
Victoria Gastroenterology
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VictoriaUnited StatesUnknown status
Gastro Intestinal Research Institute of Northern Ohio, LLC
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WestlakeUnited StatesUnknown status
Istanbul University
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IstanbulTurkey (Türkiye)Unknown status
Ege University Medical Faculty
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IzmirTurkey (Türkiye)Unknown status
Mersin University Medical Faculty
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MersinTurkey (Türkiye)Unknown status

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This page is information, not medical advice. Discuss any trial with your doctor.