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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03786380
Other study ID # 3071-305-020
Secondary ID 2019-000406-30
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 20, 2018
Est. completion date October 5, 2020

Study information

Verified date November 2021
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.


Recruitment information / eligibility

Status Terminated
Enrollment 202
Est. completion date October 5, 2020
Est. primary completion date October 5, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Successful completion of either Study RLM-MD-03 or Study RLM-MD-04 - Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures - Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator. Exclusion Criteria: - Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020 - Participant has an unresolved adverse event (AE) from a lead-in study, ie, a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study - Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic, or cardiopulmonary disease - Females who are pregnant, nursing, or planning a pregnancy during the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Relamorelin 10 µg
Relamorelin 10 µg injected subcutaneously twice daily.

Locations

Country Name City State
Argentina Maffei Centro Medico-Investigacion Clinica Aplicada C.a.b.a. Buenos Aires Province
Argentina Hospital Sirio Libanes Caba Buenos Aires Province
Argentina CIPREC Ciudad Autonoma de Buenos Aires Buenos Aires Province
Argentina Centro Universitario de Investigacion en Farmacologia Clinic Corrientes
Argentina Instituto de hematología y medicina clínica "Dr. Rubén Dávoli" Rosario Santa Fe
Argentina Instituto de Investigaciones Clínicas de Rosario Rosario Santa Fe
Australia Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated Adelaide South Australia
Australia Nepean Hospital Kingswood New South Wales
Australia The Alfred Hospital Melbourne Victoria
Australia Royal Melbourne Hospital Parkville Victoria
Australia Princess Alexandra Hospital Woolloongabba Queensland
Austria VIVIT Institute, am LKH Feldkirch Feldkirch Vorarlberg
Austria Medizinische Universitaet Innsbruck Innsbruck Tirol
Austria Klinikum Klagenfurt am Wörthersee Klagenfurt
Austria Ordination Saint Stefan Steiermark
Austria Privatklinik Wehrle-Diakonissen Salzburg
Austria Oö. Gesundheits- und Spitals-AG/LKH Steyr Steyr
Austria KH Hietzing Vienna
Austria Krankenanstalt Rudolfstiftung Wien Vienna
Belgium AZ Sint Lucas Brugge Brugge Antwerpen
Belgium Hôpitaux Iris Sud - Joseph Bracops Brussels
Belgium Universitair Ziekenhuis Antwerpen, Gastro-Enterologie, Edegem Antwerpen
Belgium UZ Brussel Jette
Belgium CHC - Clinique Saint-Joseph Liège
Brazil Hospital Universitário João de Barros Barreto - UFPA Belém Para
Brazil Centro de Pesquisa Clinica do Brasil Brasilia Distrito Federal
Brazil Instituto de Pesquisa Clínica em Campinas Campinas Sao Paulo
Brazil Scentryphar Pesquisa Clínica Ltda Campinas Sao Paulo
Brazil Universidade de Sao Paulo (USP) - Hospital das Clinicas da F Cerqueira Cesar - Sao Paulo Sao Paulo
Brazil Quanta Diagnóstico e Terapia Curitiba Parana
Brazil Hospital Universitário Walter Cantídio Fortaleza Ceara
Brazil Instituto de Estudos e Pesquisas Clínicas do Ceará - IEP/CE - Oncology Fortaleza
Brazil Instituto Catarinense de Endocrinologia e Diabetes (ICED) Joinville Santa Catarina
Brazil Hospital Sao Vicente de Paulo Passo Fundo- RS Rio Grande Do Sul
Brazil Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande Do Sul
Brazil Hospital São Lucas da PUC-RS Porto Alegre Rio Grande Do Sul
Brazil CPQuali Pesquisa Clínica Ltda São Paulo Sao Paulo
Brazil IPEC-Instituto de Pesquisa Clinica São Paulo Sao Paulo
Bulgaria MHAT Yuliya Vrevska Byala Byala
Bulgaria MHAT Dobrich AD Dobrich
Bulgaria MHAT Dr. Tota Venkova AD Gabrovo
Bulgaria UMHAT - Kaspela- EOOD Plovdiv
Bulgaria Alexandrovska University Hospital Sofia
Bulgaria Medical Center Asklepion - Humane Medicine Research EOOD Sofia
Canada South Shore Medical Arts Bridgewater Nova Scotia
Canada University of Calgary Calgary Alberta
Canada Alberta Diabetes Institute Edmonton Alberta
Canada Dr. Anil K. Gupta Medicine Professional Corporation Etobicoke Ontario
Canada CISSS de la Monteregie-Centre Greenfield Park Quebec
Canada Centre Hospitalier de l'Universite de Montreal - CHUM Montreal Quebec
Canada Recherche GCP Research Montreal Quebec
Canada The Ottawa Hospital Ottawa Ontario
Canada Central Alberta Research Centre Red Deer
Canada Eastern Health St. John's Newfoundland and Labrador
Canada Sunnybrook Health Science Centre Toronto Ontario
Canada Toronto Liver Centre Toronto Ontario
Canada Toronto Western Hospital, University Health Network Toronto Ontario
Canada Vancouver General Hospital Vancouver British Columbia
Canada Toronto Digestive Disease Associates Vaughan
Colombia Centro Cardiovascular y de Diabetes Barranquilla Atlántico
Colombia Fundación BIOS Barranquilla Atlántico
Colombia Endocare Ltda. Bogota Cundinamarca
Colombia Medplus Medicina Prepagada Bogotá Distrito Capltal
Colombia Centro Medico Imbanaco de Cali S.A. Cali Distrito Capltal
Colombia IPS Centro Medico Julian Coronel S.A Cali Valle Del Cauca
Colombia Rodrigo Botero S.A.S. Medellin Antioquia
Colombia Healthy Medical Center Zipaquirá Cundinamarca
Denmark Aalborg University Hospital Aalborg
Denmark MEA KFA Aarhus Århus
Denmark Steno Diabetes Center Copenhagen Hellerup
Denmark Nordsjaellands Hospital Hilleroed
Denmark Gastroenheden, Hvidovre hospital Hvidovre Kobenhavn
France Hôpital Louis-Mourier Colombes
France Corbeil Essonnes Corbeil Essonnes
France Service d'hépato-gastroentérologie - 7°D Grenoble
France Hospices Civils de Lyon - Hôpital Edouard Herrriot LYON Cedex 03
France CHU Nantes Nantes
France CHU de Bordeaux - Hôpital Haut-Lévêque Pessac Gironde
France CHU de Poitiers Poitiers
France Hopital Charles Nicolle Rouen Cedex
France CHRU Nancy Vandoeuvre-lès-Nancy
France Centre de Recherche Clinique Venissieux
Germany Diabetologische Schwerpunktpraxis Bad Berleburg North Rhine-Westphalia
Germany Studienzentrum Schwittay Böhlen
Germany Klinische Forschung Dresden GmbH Dresden Saxony
Germany Universitätsklinikum Giessen und Marburg GmbH Giessen
Germany Clinical Research Hamburg GmbH Hamburg
Germany Israelitisches Krankenhaus Hamburg
Germany Klinische Forschung Hamburg GmbH Hamburg
Germany Klinische Forschung Hannover-Mitte GmbH Hannover
Germany KRH Klinikum Siloah Hannover
Germany Klinische Forschung Karlsruhe GmbH Karlsruhe Baden-Württemberg
Germany Klinische Forschung Schwerin GmbH Schwerin Mecklenburg-Western Pomerania
Germany Praxis Dr. Etzrodt-Walter und Kollegen Ulm Baden-Württemberg
Hungary Semmelweis University Budapest
Hungary Stra¡zshegy Medicina Budapest
Hungary Markhot Ferenc Oktatokorhaz es Rendelointezet Eger Heves
Hungary Coromed SMO Pecs Pécs
Hungary First Department of Medicine, University of Szeged Szeged Szaged
Hungary Hetenyi Geza Hospital Szolnok
Hungary Zala Megyei Szent Rafael Korhaz Zalaegerszeg Zala
India Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Res Ahmedabad Gujarat
India Zydus Hospital Ahmedabad Gujarat
India Lifecare Clinic and Research Centre - Internal Med/Diabetolo Bangalore Karnataka
India M. S. Ramaiah medical College and Hospitals - Gastroenterolo Bangalore
India Diacon Hospital and research Center Bengaluru Karnataka
India Rajalakshmi Hospital Bengaluru Karnataka
India Victoria Hospital Bangalore Medical College and Research Ins Bengaluru Karnataka
India S.P.Medical College & Group of Hospitals Bikaner Bikaner Rajasthan
India M.V. Hospital for Diabetes & Diabetes Research Centre Chennai Tamil Nadu
India Madras Medical College & Rajiv Gandhi Govt. General Hospital Chennai Tamil Nadu
India Kovai Diabetes Speciality Centre Coimbatore Tamil Nadu
India Gleneagles Global Hospital Hyderabad
India Kumudini Devi Diabetes Research Center Hyderabad
India Eternal Hospital, Unit of Eternal Heart Care Centre and Research Institute Pvt. Ltd. Jaipur Rajasthan
India Marudhar Hospital Jaipur Rajasthan
India S.R. Kalla Memorial Gastro and General Hospital Jaipur Rajasthan
India Sawai Man Singh Hospital Jaipur Rajasthan
India Sir Ganga Ram Hospital (SGRH) Jaipur Rajasthan
India IPGME&R and SSKM Hospital Kolkata West Bengal
India M V Hospital & Research Centre Lucknow Uttar Pradesh
India Arthur Asirvatham Hospital Madurai Tamil Nadu
India Vinaya Hospital & Research Centre Mangalore Karnataka
India Bhatia Hospital Mumbai
India Chopda Medicare & Research Centre Pvt.Ltd, Magnum Heart Institute Nashik Maharashtra
India B. J. Government Medical College and Sassoon General Hospitals Pune Maharashtra
India Grant Medical Foundation Ruby Hall Clinic Pune Maharashtra
India Noble Hospital Pune Maharashtra
India University Hospital Pune Maharashtra
India Surat Institute of Digestive Sciences Hospitals Surat Gujarat
India King George Hospital Visakhapatnam Andhra Pradesh
Israel Soroka University Medical Center Beer Sheva
Israel Bnai Zion M.C. Haifa
Israel E. Wolfson Medical Center Holon
Israel Digestive Diseases Institute Jerusalem
Israel Gastroenterology Institute Petach Tikva
Israel Endocrinology & Diabetes Center Safed
Israel Gastroenterology Institute Tel Aviv
Italy Ospedale Cardinal Massaia Asti
Italy University of Bari Bari
Italy Azienda Ospedaliera Rilievo Nazionale Alta Specialita (ARNAS) Garibaldi Catania
Italy Universita Magna Graecia di Catanzaro Catanzaro
Italy IRCCS Azienda Ospedaliera Universitaria San Martino Genova
Italy Universita degli Studi di Napoli Federico II Napoli
Italy Azienda Opsedaliera di Padova Padova
Italy IRCCS S.Matteo Hospital Foundation, University of Pavia Pavia
Italy University of Pisa - Cisanello Hospital Pisa
Italy Policlinico Gemelli, Divisione di Endocrinologia e Malattie del Metabolismo Rome Rome Roma
Italy Gruppo Humanitas - Humanitas Research Hospital Rozzano
Italy Universita' Di Salerno- Aou Ruggi D'aragona Salerno
Italy IRCCS Policlinico San Donato San Donato Milanese Milan
Italy IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo
Italy Clinical Institute Beato Matteo Vigevano Pavia
Korea, Republic of Chonbuk National University Hospital Jeonju Jeollabuk-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Sanggye Paik Hospital, Inje University College of Medicine Seoul
Latvia Polana-D Daugavpils
Latvia Ogorelova Jelena GP Kraslava
Latvia Digestive Diseases Centre GASTRO Riga
Latvia Pauls Stradins Clinical University Hospital, Endokrinologijas nodala Riga
Malaysia Hospital Sultanah Bahiyah Alor Setar Kedah
Malaysia University Malaya Medical Centre Kuala Lumpur
Malaysia Universiti Sains Malaysia Kubang Kerian
Malaysia Hospital Taiping Taiping
Mexico Practice Dr Gerardo Gonzalez Acapulco
Mexico Hospital Cardiológica Aguascalientes Aguascalientes
Mexico Centro Especializado en Investigación Clínica S.C. Boca del Rio Veracruz
Mexico Instituto de Diabetes Obesidad y Nutrición SC Cuautla Morelos
Mexico CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición) Durango
Mexico Dioderm Instituto de Investigación Durango
Mexico Consultorio Medico Guadalajara Jalisco
Mexico Unidad de Investigación Clínica Cardiometabolica de Occidente Guadalajara Jalisco
Mexico Unidad de Investigación clínica y atención Médica HEPA S.C. Guadalajara Jalisco
Mexico Investigación Médica Sonora, S.C. Hermosillo Sonora
Mexico Centro de Investigacion Morales Vargas - CIMOVA León Guanajuato
Mexico Centro de Desarrollo Biomédico Mérida Yucatan
Mexico Clinica OMEGA Mexico Distrito Federal
Mexico Clinicos Asociados BOCM SC Mexico Distrito Federal
Mexico Instituto Nacional de Ciencias Medicas y Nutricion Mexico Distrito Federal
Mexico Medical and Nutritional Trials México DF Distrito Federal
Mexico Accelerium Clinical Research Monterrey Nuevo Leon
Mexico Centro Medico Christus Muguerza Sur Monterrey Nuevo Leon
Mexico Centro de Diabetes de Pachuca Pachuca Hidalgo
Mexico Sociedad de Metabolismo y Corazón, S.C. Veracruz
Philippines Perpetual Succor Hospital Cebu City
Philippines West Visayas State University Medical Center IloIlo City
Philippines Ospital ng Makati Makati City
Philippines Manila Doctors Hospital Manila
Philippines San Juan De Dios Educational Foundation, Inc. Pasay
Philippines St. Luke's Medical Center Quezon City
Philippines Cardinal Santos Medical Center San Juan
Poland Szpital Uniwestytetu Medycznego w Bialymstoku Bialystok
Poland Nasz Lekarz Osrodek Badan Klinicznych Bydgoszcz
Poland Vitamed Bydgoszcz
Poland Centrum Medyczne Lukamed Chojnice
Poland Silmedic Sp z o o Katowice
Poland CenterMed Krakow Ltd Krakow
Poland Specjalistyczny Gabinet Neurologiczny Marta Banach Kraków
Poland Centrum Medyczne Medyk Lublin
Poland Wojewodzki Szpital Specjalistyczny w Olsztynie Olsztyn
Poland Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer sp. Z o.o. Pruszków
Poland Endoskopia SP. Z O.O. Sopot
Poland Centrum Medyczne Pratia Warszawa Warszawa Warazawa
Poland Powiatowe Centrum Medyczne w Wolowie Wolów
Poland Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska Wroclaw
Poland NZOZ Vita - Diabetica Malgorzata Buraczyk, Diabetes Clinic, Ystok Bia
Poland Zamosc Zamosc
Romania National Institute of Endocrinology Bucharest
Romania Sana Medical Center Bucharest
Romania AMES Research Center SRL Calarasi
Romania ClinTrial Medical Center, Pulmonology Department Dobrosloveni Resca, Olt County
Romania Polisano-Clinic Sibiu
Russian Federation Kazan State Medical University Kazan
Russian Federation Saint-Petersburg City Pokrovskaya Hospital Leningrad Region
Russian Federation FSBI National medical endocrinology research centre Moscow
Russian Federation Moscow Regional Research Clinical Institute named by MF Vladimirski Moscow
Russian Federation Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko Nizhny
Russian Federation Scientific Institute of Clinical and Experimental Lymphology Novosibirsk Novosibirskaya Oblast
Russian Federation Rostov on Don Rostov on Don
Russian Federation Rostov State Medical University Rostov-on-Don
Russian Federation Millitary-medical Academy, department of hospital therapy Saint-Petersburg Sankt-Peterburg
Russian Federation North-Western State Medical University named after I. I. Mechnikov Saint-Petersburg Sankt-Peterburg
Russian Federation MUZ City Clinical Hospital 9 Saratov
Russian Federation Saratov City Clinical Hospital 12 Saratov
Singapore Changi General Hospital Singapore
Singapore National University Hospital Singapore
Singapore Singapore General Hospital Singapore
South Africa FARMOVS Bloemfontein Free State
South Africa Moriana Clinical Research Brandfort
South Africa Synexus Helderberg Clinical Research Centre Cape Town
South Africa TREAD Research Cape Town
South Africa Soweto CTC Johannesburg Gauteng
South Africa Wits Clinical Research Johannesburg Gauteng
South Africa Endocare Research Paarl Western Cape
South Africa Synexus Stanza Clincal Reaserch Centre Pretoria Gauteng
South Africa Syenxus Watermeyer Dedicated Research Val De Grace
Spain Hospital Clinico Universitario San Carlos Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Principe de Asturias Madrid
Spain Hospital Clinico Universitario de Salamanca Salamanca
Spain Hospital Universitario Virgen del Rocío Sevilla
Spain Hospital Universitario Miguel Servet Zaragoza
Thailand Faculty of Medicine, Siriraj Hospital, Mahidol University Bangkok
Thailand Phramongkutklao Hospital Bangkok
Thailand Maharaj Nakorn Chiang Mai Hospital Chiang Mai
Ukraine Municipal nonprofit entity "Chernigiv city hospital #2" of Chernigiv municipal council, therapeutic department Chernihiv
Ukraine Regional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious diseases, c.C Chernivtsi
Ukraine Regional Public Organization Chernivtsi Regional Endocrinology Center Chernivtsi
Ukraine State Institution Ukrainian State Research Institute Dnipro Dnipropetrovs'ka Oblast
Ukraine SU Clinic of medical academy of SI Dnepropetrovsk medical cacadamy of MoH of Ukraine Dnipro
Ukraine "Kryvyi Rih City Hospital #3" of Dnipropetrovsk Regional Council Dnipropetrovsk Region Dnipropetrovs'ka Oblast
Ukraine Ivano-Frankivsk Central City Clinical Hospital Ivano-Frankivsk
Ukraine Ivano-Frankivsk National Medical University Ivano-Frankivsk Ivano-Frankivs'ka Oblast'
Ukraine "State Institution "National Institute of Therapy named after. L.T. Maloi NAMNU" / Government Institution "L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine", Department of the study of diseases of the digestive Kharkiv
Ukraine Clinical Endocrinology of SI V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine Kharkiv
Ukraine Municipal nonprofit entity "City clinical hospital #2 n.a. Prof.O.O.Shalimov" of Kharkiv municipal council, department of endocrinology Kharkiv
Ukraine Communal Institution Kherson City Clinical Hospital Kherson
Ukraine Institute of Endocrinology and Metabolism im. V. P. Komisarenka NAMS Ukraine Kyiv
Ukraine Kyiv city clinical endocrinology center, department of general endocrine pathology and metabolism, c. Kyiv Kyiv Kyïv
Ukraine Kyiv Railway Clinical Hospital #2 of Branch Healthcare Center of the PJSC Ukranian Railway, Endocrynology Department Kyiv
Ukraine Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv Kyiv
Ukraine Medical Center Universal Clinic OberigMedical Center Universal Clinic Oberig / Medical Center "Universal Clininc "Oberig" of LLC "Capital", Gastroenterological Center, c. Kyiv Kyiv
Ukraine Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit Kyiv
Ukraine Municipal Institution Lutsk City Clinical Hospital Lutsk Volyos'ka Oblast'
Ukraine City Hospital #1, department of endocrinology, c. Mykolayiv Mykolaiv
Ukraine Communal Institution "Odesa Regional Clinical Hospital", Out-patient department Odesa
Ukraine Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University Odesa
Ukraine Poltava Regional Clinical Hospital Poltava
Ukraine Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital Sumy
Ukraine Ternopil University Hospital, Regional Center for Gastroenterology with Hepatology, Department of Gastroenterology Ternopil
Ukraine Medical Center of the Limited Liability Company "Health Clinic", Medical Clinical Research Center, Department of Gastroenterology, Hepatology and Endocrinology Vinnytsia
Ukraine Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", gastroenterological department, Vinnytsia National Pirogov Memorial Medical University, department of propedeutics of internal medicine, c. Vinnytsia Vinnytsia
Ukraine Private Small-Scale Enterprise Medical Center Pulse Vinnytsia
Ukraine Vinnytsia Regional Clinical highly specialized Endocrinology Centre Vinnytsia
Ukraine DRRI-Vinnytsia National Pirogov Memorial Medical University Vinnytsya Vinnyts'ka Oblast'
Ukraine "Municipal Institution ""City Hospital #7"", polyclinic department, c. Zaporizhzhia" Zaporizhzhia
Ukraine 6th City Clinical Hospital, c. Zaporizhzhia Zaporizhzhia
Ukraine Municipal Institution-Zaporizhzhia Regional Clinical Hospital Zaporizhzhia
United Kingdom MAC Research Barnsley
United Kingdom MAC Clinical Research, Kaman Court Blackpool
United Kingdom MAC Research, Exchange House Cannock Staffordshire
United Kingdom Mid Essex Hospital Services NHS Trust Broomfield Hospital Chelmsford
United Kingdom Western General Hospital Edinburgh Edinburgh
United Kingdom MAC Clinical Research, Monarch House Leeds
United Kingdom MAC Clinical Research Liverpool
United Kingdom University College London Hospita London
United Kingdom Wingate Institute London
United Kingdom MAC Clinical Research Manchester Manchester
United Kingdom University Hospital of South Manchester Manchester
United Kingdom The Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne
United Kingdom Biomedical Research Centre Nottingham
United Kingdom Royal Oldham Hospital Oldham Lancashire
United Kingdom MAC Clinical Research, GAC House Stockton-on-Tees
United Kingdom University Hospitals of North Midlands Stoke on Trent Staffordshire
United Kingdom St George's Hospital Tooting
United Kingdom Royal Wolverhampton NHS Trust Wolverhampton
United States Lovelace Scientific Resources, Inc. Albuquerque New Mexico
United States HCP Clinical Research LLC Anaheim California
United States Pinnacle Research Group Anniston Alabama
United States Texas Clinical Research Institute, LLC Arlington Texas
United States Asheville Gastroenterology Associates Asheville North Carolina
United States North Alabama Research Center, LLC Athens Alabama
United States Atlanta Diabetes Associates Atlanta Georgia
United States Emory University Atlanta Georgia
United States University of Colorado, Denver Aurora Colorado
United States Avant Research Associates,LLC Austin Texas
United States Visionary Investigators Network Aventura Florida
United States Delta Research Partners Bastrop Louisiana
United States DiscoveResearch, Inc. Beaumont Texas
United States Dayton Gastroenterology,Inc. Beavercreek Ohio
United States University of Alabama at Birmingham Birmingham Alabama
United States River Birch Research Alliance, LLC Blue Ridge Georgia
United States Test Center 3 Brick New Jersey
United States Gastroenterology Associates of Fairfield County, P.C. Bridgeport Connecticut
United States Connecticut Clinical Research Foundation Bristol Connecticut
United States Commonwealth Clinical Studies, PLLC. Brockton Massachusetts
United States Gwinnett Research Institute Buford Georgia
United States Hope Clinical Research Canoga Park California
United States Summit Clinical Research, LLC. Carnesville Georgia
United States Biocon Clinical Research, LLC Caro Michigan
United States ClinRx Research, LLC Carrollton Texas
United States Del Sol Research Management, LLC Chandler Arizona
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Clinical Trials of South Carolina Charleston South Carolina
United States Test Center 2 Charlotte North Carolina
United States Clinsearch Chattanooga Tennessee
United States Clinical Research Institute of Michigan Chesterfield Michigan
United States Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research Chevy Chase Maryland
United States GW Research Inc Chula Vista California
United States Clinical Research of West Florida Clearwater Florida
United States Gastro Florida Clearwater Florida
United States Innovative Research of West Florida, Inc. Clearwater Florida
United States Digestive Disease & Surgery Institute Cleveland Ohio
United States The MetroHealth System MHS Cleveland Ohio
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States Gastro Center of Maryland Columbia Maryland
United States Aventiv Research, Inc. Columbus Ohio
United States Endocrinology Research Associates, Inc. Columbus Ohio
United States Hometown Urgent Care and Research Columbus Ohio
United States The Ohio State University, Wexner Medical Center Columbus Ohio
United States PMG Research of Charlotte, LLC Concord North Carolina
United States MNGI Digestive Health Coon Rapids Minnesota
United States ALL Medical Research LLC Cooper City Florida
United States Kindred Medical Institute for Clinical Trials, LLC Corona California
United States Aurora Care Clinic, LLC Costa Mesa California
United States Tri-State Gastroenterology Crestview Hills Kentucky
United States Avant Research Associates LLC Crowley Louisiana
United States Partners in Clinical Research, LLC Cumberland Rhode Island
United States American Research Institute, Inc Cutler Bay Florida
United States Top Medical Research Cutler Bay Florida
United States Carolina Digestive Health Associates, PA Davidson North Carolina
United States Clinical Inquest Center Ltd. Dayton Ohio
United States iResearch Atlanta LLC Decatur Georgia
United States Digestive Health Specialist of the South East Dothan Alabama
United States AGA Clinical Research Associates, LLC Egg Harbor Township New Jersey
United States Texas Tech University Health Sciences, Center Division of Gastroenterology El Paso Texas
United States Diagnamics Inc. Encinitas California
United States Denver Esophageal and Stomach Center Englewood Colorado
United States North Shore University Health System Evanston Illinois
United States MediSphere Medical Research Center, LLC Evansville Indiana
United States Verity Research Inc. Fairfax Virginia
United States Cumberland Research Associates, LLC Fayetteville North Carolina
United States Aa Mrc, Llc Flint Michigan
United States G & L Research, LLC Foley Alabama
United States Valley View Wellness and Medical Center - VVCRD Clinical Research Garden Grove California
United States DHAT Research Institute Garland Texas
United States Gastro One Germantown Tennessee
United States Woodholme Gastroenterology Associates, P.A. Glen Burnie Maryland
United States Long Island Gastrointestinal Research Group LLP Great Neck New York
United States Triad Clinical Trials Greensboro North Carolina
United States Gastroenterology Associates, PA Greenville South Carolina
United States Medical Research Center of Connecticut, LLC Hamden Connecticut
United States National Clinical, LLC Hamtramck Michigan
United States Palmetto Research, LLC Hialeah Florida
United States Vida Clinical Trials Homestead Florida
United States Cronola LLC Houma Louisiana
United States Amir Ali Hassan, MD, PA Houston Texas
United States Baylor College of Medicine Medical Center Houston Texas
United States Biopharma Informatic Inc., Research Center Houston Texas
United States Rodriguez Clinical Trials Houston Texas
United States Rocky Mountain Diabetes and Osteoporosis Center, PA Idaho Falls Idaho
United States Indiana University Health University Hospital Indianapolis Indiana
United States Nature Coast Clinical Research Inverness Florida
United States University of Iowa Hospital and Clinics Iowa City Iowa
United States University of Florida Jacksonville Florida
United States Queens Hospital Center Jamaica New York
United States American Research, LLC Jeffersonville Indiana
United States United Health Services Hospitals, Inc. Johnson City New York
United States University of Kansas Medical Center Kansas City Kansas
United States Vidant Multispeciality Clinic - Kinston Kinston North Carolina
United States University of California San Diego La Jolla California
United States Centex Studies, Inc. - Lake Charles- Clinical Trials of SWLA, LLC Lake Charles Louisiana
United States Florida Research Institute Lakewood Ranch Florida
United States Om Research LLC Lancaster California
United States Advanced Biomedical Research of America Las Vegas Nevada
United States Clinical Research of South Nevada Las Vegas Nevada
United States Digestive Disease Specialists Las Vegas Nevada
United States Palm Research Center Las Vegas Nevada
United States Family Medical Associates, Research Department Levittown Pennsylvania
United States Applied Research Center of Arkansas Little Rock Arkansas
United States Preferred Clinical Research Partners Little Rock Arkansas
United States Torrance Clinical Research Institute, Inc. Lomita California
United States Tibor Rubin VA Medical Center Long Beach California
United States Angel City Research Inc. Los Angeles California
United States University of Louisville Louisville Kentucky
United States Blue Ridge Medical Research Lynchburg Virginia
United States Cfagi Llc Maitland Florida
United States Manassas Clinical Research Centre Manassas Virginia
United States Tandem Clinical Research Marrero Louisiana
United States New Orleans Research Institute - Metropolitan Gastroenterology Associates Metairie Louisiana
United States Advanced Medical Research Institute Miami Florida
United States AMPM Research Clinic Miami Florida
United States APF Research LLC Miami Florida
United States Florida Research Center, Inc. Miami Florida
United States Panax Clinical Research Miami Lakes Florida
United States Savin Medical Group LLC Miami Lakes Florida
United States NYU Winthrop Hospital, Clinical Trials Center Mineola New York
United States Facey Medical Foundation Mission Hills California
United States Montana Medical Research Missoula Montana
United States Alabama Medical Group, PC Mobile Alabama
United States Diabetes and Endocrinology Consultants, PC Morehead City North Carolina
United States West Virginia University Morgantown West Virginia
United States Gastroenterology Group of Naples Naples Florida
United States Quality Medical Research Nashville Tennessee
United States Weill Cornell Medical College New York New York
United States Arkansas Gastroenterology North Little Rock Arkansas
United States Henry Ford Health System Novi Michigan
United States Southwest Gastroenterology Oak Lawn Illinois
United States Sensible Healthcare Ocoee Florida
United States Advanced Research Institute, Inc. Ogden Utah
United States Digestive Disease Specialists Inc Oklahoma City Oklahoma
United States Memorial Clinical Research Oklahoma City Oklahoma
United States Heartland Clinical Research, Inc Omaha Nebraska
United States Stanford Hospital Palo Alto California
United States Gulf Region Clinical Research Institute Pensacola Florida
United States University of Pennsylvania Philadelphia Pennsylvania
United States Phoenix Clinical LLC. Phoenix Arizona
United States Allegheny Endocrinology Associates Pittsburgh Pennsylvania
United States Preferred Primary Care Physicians, Inc. Pittsburgh Pennsylvania
United States TriWest Research Associates Poway California
United States Health Science Research Center Pratt Kansas
United States Health Concepts Rapid City South Dakota
United States VA Medical Center McGuire VAMC Richmond Virginia
United States Infinite Clinical Trials Riverdale Georgia
United States Test Center 4 Roanoke Virginia
United States Washington University in St. Louis Saint Louis Missouri
United States PMG Research Salisbury Salisbury North Carolina
United States Test Center Salt Lake City Utah
United States Clinical Trials of Texas, Inc. San Antonio Texas
United States Digestive Center of South Texas San Antonio Texas
United States SAGACT PLLC., San Antonio Gastroenterology Associates, PA San Antonio Texas
United States Clinical Applications Laboratories, Inc. San Diego California
United States Medical Associates Research Group, Inc San Diego California
United States Syrentis Clinical Research Santa Ana California
United States Guthrie Clinical Research Sayre Pennsylvania
United States Frontier Clinical Research, LLC Scottdale Pennsylvania
United States Montgomery Medical, Inc. Smithfield Pennsylvania
United States Coastal Research Associates, Inc. South Weymouth Massachusetts
United States Texas Digestive Disease Consultants Southlake Texas
United States Southern Illinois University School of Medicine Springfield Illinois
United States Washington Gastroenterology PLLC Tacoma Washington
United States Gastro Florida Tampa Florida
United States University of South Florida Tampa Florida
United States Cotton-O'Neil Clinical Research Center - Digestive Health Topeka Kansas
United States Troy Gastroenterology, PC dba Center for Digestive Health Troy Michigan
United States Adobe Clinical Research LLC Tucson Arizona
United States Del Sol Research Management, LLC Tucson Arizona
United States Options Health Research, LLC Tulsa Oklahoma
United States Preferred Primary Care Physicians, Jacob Murphy Uniontown Pennsylvania
United States Upland Clinical Research Upland California
United States Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research Wadsworth Ohio
United States Integrated Clinical Trial Services Inc West Des Moines Iowa
United States Advanced Clinical Research West Jordan Utah
United States Clinical Trials of America, Inc. West Monroe Louisiana
United States Boston VA Healthcare System West Roxbury Massachusetts
United States Cleveland Clinic Florida - Weston Weston Florida
United States New Hope Research Development Whittier California
United States Professional Research Network of Kansas, LLC Wichita Kansas
United States Via Christi Clinic, PA Wichita Kansas
United States PMG Research of Wilmington, LLC Wilmington North Carolina
United States PMG Research of Winston-Salem, LLC Winston-Salem North Carolina
United States The Center for Clinical Research Winston-Salem North Carolina
United States Wake Forest Baptist Health Winston-Salem North Carolina
United States Cardinal Internal Medicine Woodbridge Virginia
United States Gastroenterology Associates of Western Michigan Wyoming Michigan

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Colombia,  Denmark,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Latvia,  Malaysia,  Mexico,  Philippines,  Poland,  Romania,  Russian Federation,  Singapore,  South Africa,  Spain,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug. Up to approximately 22 months
Primary Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. Baseline (Day 1) up to approximately 22 months
Primary Number of Participants With Clinically Meaningful Trends for Vital Signs Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant. Up to approximately 22 months
Primary Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant. Up to approximately 22 months
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