Diabetic Gastroparesis Study 05

NCT ID: NCT03786380

Last Updated: 2021-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2020-10-05

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroparesis

Keywords

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Diabetic Gastroparesis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Relamorelin 10 μg

Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months.

Group Type EXPERIMENTAL

Relamorelin 10 μg

Intervention Type DRUG

Relamorelin 10 μg injected subcutaneously twice daily.

Interventions

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Relamorelin 10 μg

Relamorelin 10 μg injected subcutaneously twice daily.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harvy Schneier

Role: STUDY_DIRECTOR

Allergan

Locations

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Pinnacle Research Group

Anniston, Alabama, United States

Site Status

North Alabama Research Center, LLC

Athens, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Digestive Health Specialist of the South East

Dothan, Alabama, United States

Site Status

G & L Research, LLC

Foley, Alabama, United States

Site Status

Alabama Medical Group, PC

Mobile, Alabama, United States

Site Status

Del Sol Research Management, LLC

Chandler, Arizona, United States

Site Status

Phoenix Clinical LLC.

Phoenix, Arizona, United States

Site Status

Adobe Clinical Research LLC

Tucson, Arizona, United States

Site Status

Del Sol Research Management, LLC

Tucson, Arizona, United States

Site Status

Preferred Clinical Research Partners

Little Rock, Arkansas, United States

Site Status

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Site Status

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Site Status

HCP Clinical Research LLC

Anaheim, California, United States

Site Status

Hope Clinical Research

Canoga Park, California, United States

Site Status

GW Research Inc

Chula Vista, California, United States

Site Status

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, United States

Site Status

Aurora Care Clinic, LLC

Costa Mesa, California, United States

Site Status

Diagnamics Inc.

Encinitas, California, United States

Site Status

Valley View Wellness and Medical Center - VVCRD Clinical Research

Garden Grove, California, United States

Site Status

University of California San Diego

La Jolla, California, United States

Site Status

Om Research LLC

Lancaster, California, United States

Site Status

Torrance Clinical Research Institute, Inc.

Lomita, California, United States

Site Status

Tibor Rubin VA Medical Center

Long Beach, California, United States

Site Status

Angel City Research Inc.

Los Angeles, California, United States

Site Status

Facey Medical Foundation

Mission Hills, California, United States

Site Status

Stanford Hospital

Palo Alto, California, United States

Site Status

TriWest Research Associates

Poway, California, United States

Site Status

Clinical Applications Laboratories, Inc.

San Diego, California, United States

Site Status

Medical Associates Research Group, Inc

San Diego, California, United States

Site Status

Syrentis Clinical Research

Santa Ana, California, United States

Site Status

Upland Clinical Research

Upland, California, United States

Site Status

New Hope Research Development

Whittier, California, United States

Site Status

University of Colorado, Denver

Aurora, Colorado, United States

Site Status

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Site Status

Denver Esophageal and Stomach Center

Englewood, Colorado, United States

Site Status

Gastroenterology Associates of Fairfield County, P.C.

Bridgeport, Connecticut, United States

Site Status

Connecticut Clinical Research Foundation

Bristol, Connecticut, United States

Site Status

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States

Site Status

Visionary Investigators Network

Aventura, Florida, United States

Site Status

Gastro Florida

Clearwater, Florida, United States

Site Status

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

Site Status

Clinical Research of West Florida

Clearwater, Florida, United States

Site Status

ALL Medical Research LLC

Cooper City, Florida, United States

Site Status

American Research Institute, Inc

Cutler Bay, Florida, United States

Site Status

Top Medical Research

Cutler Bay, Florida, United States

Site Status

Palmetto Research, LLC

Hialeah, Florida, United States

Site Status

Vida Clinical Trials

Homestead, Florida, United States

Site Status

Nature Coast Clinical Research

Inverness, Florida, United States

Site Status

University of Florida

Jacksonville, Florida, United States

Site Status

Florida Research Institute

Lakewood Rch, Florida, United States

Site Status

Cfagi Llc

Maitland, Florida, United States

Site Status

APF Research LLC

Miami, Florida, United States

Site Status

AMPM Research Clinic

Miami, Florida, United States

Site Status

Advanced Medical Research Institute

Miami, Florida, United States

Site Status

Florida Research Center, Inc.

Miami, Florida, United States

Site Status

Panax Clinical Research

Miami Lakes, Florida, United States

Site Status

Savin Medical Group LLC

Miami Lakes, Florida, United States

Site Status

Gastroenterology Group of Naples

Naples, Florida, United States

Site Status

Sensible Healthcare

Ocoee, Florida, United States

Site Status

Gulf Region Clinical Research Institute

Pensacola, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Gastro Florida

Tampa, Florida, United States

Site Status

Cleveland Clinic Florida - Weston

Weston, Florida, United States

Site Status

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

River Birch Research Alliance, LLC

Blue Ridge, Georgia, United States

Site Status

Gwinnett Research Institute

Buford, Georgia, United States

Site Status

Summit Clinical Research, LLC.

Carnesville, Georgia, United States

Site Status

iResearch Atlanta LLC

Decatur, Georgia, United States

Site Status

Infinite Clinical Trials

Riverdale, Georgia, United States

Site Status

Rocky Mountain Diabetes and Osteoporosis Center, PA

Idaho Falls, Idaho, United States

Site Status

North Shore University Health System

Evanston, Illinois, United States

Site Status

Southwest Gastroenterology

Oak Lawn, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

MediSphere Medical Research Center, LLC

Evansville, Indiana, United States

Site Status

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Site Status

American Research, LLC

Jeffersonville, Indiana, United States

Site Status

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Site Status

Integrated Clinical Trial Services Inc

West Des Moines, Iowa, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Health Science Research Center

Pratt, Kansas, United States

Site Status

Cotton-O'Neil Clinical Research Center - Digestive Health

Topeka, Kansas, United States

Site Status

Professional Research Network of Kansas, LLC

Wichita, Kansas, United States

Site Status

Via Christi Clinic, PA

Wichita, Kansas, United States

Site Status

Tri-State Gastroenterology

Crestview Hills, Kentucky, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Delta Research Partners

Bastrop, Louisiana, United States

Site Status

Avant Research Associates LLC

Crowley, Louisiana, United States

Site Status

Cronola LLC

Houma, Louisiana, United States

Site Status

Centex Studies, Inc. - Lake Charles- Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, United States

Site Status

Tandem Clinical Research

Marrero, Louisiana, United States

Site Status

New Orleans Research Institute - Metropolitan Gastroenterology Associates

Metairie, Louisiana, United States

Site Status

Clinical Trials of America, Inc.

West Monroe, Louisiana, United States

Site Status

Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Site Status

Gastro Center of Maryland

Columbia, Maryland, United States

Site Status

Woodholme Gastroenterology Associates, P.A.

Glen Burnie, Maryland, United States

Site Status

Commonwealth Clinical Studies, PLLC.

Brockton, Massachusetts, United States

Site Status

Coastal Research Associates, Inc.

South Weymouth, Massachusetts, United States

Site Status

Boston VA Healthcare System

West Roxbury, Massachusetts, United States

Site Status

Biocon Clinical Research, LLC

Caro, Michigan, United States

Site Status

Clinical Research Institute of Michigan

Chesterfield, Michigan, United States

Site Status

Aa Mrc, Llc

Flint, Michigan, United States

Site Status

National Clinical, LLC

Hamtramck, Michigan, United States

Site Status

Henry Ford Health System

Novi, Michigan, United States

Site Status

Troy Gastroenterology, PC dba Center for Digestive Health

Troy, Michigan, United States

Site Status

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, United States

Site Status

MNGI Digestive Health

Coon Rapids, Minnesota, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Montana Medical Research

Missoula, Montana, United States

Site Status

Heartland Clinical Research, Inc

Omaha, Nebraska, United States

Site Status

Clinical Research of South Nevada

Las Vegas, Nevada, United States

Site Status

Advanced Biomedical Research of America

Las Vegas, Nevada, United States

Site Status

Digestive Disease Specialists

Las Vegas, Nevada, United States

Site Status

Palm Research Center

Las Vegas, Nevada, United States

Site Status

Test Center 3

Brick, New Jersey, United States

Site Status

AGA Clinical Research Associates, LLC

Egg Harbor, New Jersey, United States

Site Status

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, United States

Site Status

Long Island Gastrointestinal Research Group LLP

Great Neck, New York, United States

Site Status

Queens Hospital Center

Jamaica, New York, United States

Site Status

United Health Services Hospitals, Inc.

Johnson City, New York, United States

Site Status

NYU Winthrop Hospital, Clinical Trials Center

Mineola, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Asheville Gastroenterology Associates

Asheville, North Carolina, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Test Center 2

Charlotte, North Carolina, United States

Site Status

PMG Research of Charlotte, LLC

Concord, North Carolina, United States

Site Status

Carolina Digestive Health Associates, PA

Davidson, North Carolina, United States

Site Status

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Site Status

Triad Clinical Trials

Greensboro, North Carolina, United States

Site Status

Vidant Multispeciality Clinic - Kinston

Kinston, North Carolina, United States

Site Status

Diabetes and Endocrinology Consultants, PC

Morehead City, North Carolina, United States

Site Status

PMG Research Salisbury

Salisbury, North Carolina, United States

Site Status

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

Site Status

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States

Site Status

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Site Status

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Site Status

Dayton Gastroenterology,Inc.

Beavercreek, Ohio, United States

Site Status

The MetroHealth System MHS

Cleveland, Ohio, United States

Site Status

Digestive Disease & Surgery Institute

Cleveland, Ohio, United States

Site Status

Endocrinology Research Associates, Inc.

Columbus, Ohio, United States

Site Status

The Ohio State University, Wexner Medical Center

Columbus, Ohio, United States

Site Status

Aventiv Research, Inc.

Columbus, Ohio, United States

Site Status

Hometown Urgent Care and Research

Columbus, Ohio, United States

Site Status

Clinical Inquest Center Ltd.

Dayton, Ohio, United States

Site Status

Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research

Wadsworth, Ohio, United States

Site Status

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, United States

Site Status

Memorial Clinical Research

Oklahoma City, Oklahoma, United States

Site Status

Options Health Research, LLC

Tulsa, Oklahoma, United States

Site Status

Family Medical Associates, Research Department

Levittown, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, United States

Site Status

Preferred Primary Care Physicians, Inc.

Pittsburgh, Pennsylvania, United States

Site Status

Guthrie Clinical Research

Sayre, Pennsylvania, United States

Site Status

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, United States

Site Status

Montgomery Medical, Inc.

Smithfield, Pennsylvania, United States

Site Status

Preferred Primary Care Physicians, Jacob Murphy

Uniontown, Pennsylvania, United States

Site Status

Partners in Clinical Research, LLC

Cumberland, Rhode Island, United States

Site Status

Clinical Trials of South Carolina

Charleston, South Carolina, United States

Site Status

Gastroenterology Associates, PA

Greenville, South Carolina, United States

Site Status

Health Concepts

Rapid City, South Dakota, United States

Site Status

Clinsearch

Chattanooga, Tennessee, United States

Site Status

Gastro One

Germantown, Tennessee, United States

Site Status

Quality Medical Research

Nashville, Tennessee, United States

Site Status

Texas Clinical Research Institute, LLC

Arlington, Texas, United States

Site Status

Avant Research Associates,LLC

Austin, Texas, United States

Site Status

DiscoveResearch, Inc.

Beaumont, Texas, United States

Site Status

ClinRx Research, LLC

Carrollton, Texas, United States

Site Status

Texas Tech University Health Sciences, Center Division of Gastroenterology

El Paso, Texas, United States

Site Status

DHAT Research Institute

Garland, Texas, United States

Site Status

Baylor College of Medicine Medical Center

Houston, Texas, United States

Site Status

Biopharma Informatic Inc., Research Center

Houston, Texas, United States

Site Status

Rodriguez Clinical Trials

Houston, Texas, United States

Site Status

Amir Ali Hassan, MD, PA

Houston, Texas, United States

Site Status

Digestive Center of South Texas

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Site Status

SAGACT PLLC., San Antonio Gastroenterology Associates, PA

San Antonio, Texas, United States

Site Status

Texas Digestive Disease Consultants

Southlake, Texas, United States

Site Status

Advanced Research Institute, Inc.

Ogden, Utah, United States

Site Status

Test Center

Salt Lake City, Utah, United States

Site Status

Advanced Clinical Research

West Jordan, Utah, United States

Site Status

Verity Research Inc.

Fairfax, Virginia, United States

Site Status

Blue Ridge Medical Research

Lynchburg, Virginia, United States

Site Status

Manassas Clinical Research Centre

Manassas, Virginia, United States

Site Status

VA Medical Center McGuire VAMC

Richmond, Virginia, United States

Site Status

Test Center 4

Roanoke, Virginia, United States

Site Status

Cardinal Internal Medicine

Woodbridge, Virginia, United States

Site Status

Washington Gastroenterology PLLC

Tacoma, Washington, United States

Site Status

West Virginia University

Morgantown, West Virginia, United States

Site Status

Maffei Centro Medico-Investigacion Clinica Aplicada

C.a.b.a., Buenos Aires, Argentina

Site Status

Hospital Sirio Libanes

CABA, Buenos Aires, Argentina

Site Status

CIPREC

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Instituto de Investigaciones Clínicas de Rosario

Rosario, Santa Fe Province, Argentina

Site Status

Instituto de hematología y medicina clínica "Dr. Rubén Dávoli"

Rosario, Santa Fe Province, Argentina

Site Status

Centro Universitario de Investigacion en Farmacologia Clinic

Corrientes, , Argentina

Site Status

Nepean Hospital

Kingswood, New South Wales, Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated

Adelaide, South Australia, Australia

Site Status

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Ordination

Saint Stefan, Styria, Austria

Site Status

Medizinische Universitaet Innsbruck

Innsbruck, Tyrol, Austria

Site Status

VIVIT Institute, am LKH Feldkirch

Feldkirch, Vorarlberg, Austria

Site Status

Klinikum Klagenfurt am Wörthersee

Klagenfurt, , Austria

Site Status

Privatklinik Wehrle-Diakonissen

Salzburg, , Austria

Site Status

Oö. Gesundheits- und Spitals-AG/LKH Steyr

Steyr, , Austria

Site Status

Krankenanstalt Rudolfstiftung Wien

Vienna, , Austria

Site Status

KH Hietzing

Vienna, , Austria

Site Status

AZ Sint Lucas Brugge

Bruges, Antwerpen, Belgium

Site Status

Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,

Edegem, Antwerpen, Belgium

Site Status

Hôpitaux Iris Sud - Joseph Bracops

Brussels, , Belgium

Site Status

UZ Brussel

Jette, , Belgium

Site Status

CHC - Clinique Saint-Joseph

Liège, , Belgium

Site Status

Hospital Universitário Walter Cantídio

Fortaleza, Ceará, Brazil

Site Status

Centro de Pesquisa Clinica do Brasil

Brasília, Federal District, Brazil

Site Status

Quanta Diagnóstico e Terapia

Curitiba, Paraná, Brazil

Site Status

Hospital Universitário João de Barros Barreto - UFPA

Belém, Pará, Brazil

Site Status

Hospital Sao Vicente de Paulo

Passo Fundo- RS, Rio Grande do Sul, Brazil

Site Status

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital São Lucas da PUC-RS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto Catarinense de Endocrinologia e Diabetes (ICED)

Joinville, Santa Catarina, Brazil

Site Status

Scentryphar Pesquisa Clínica Ltda

Campinas, São Paulo, Brazil

Site Status

Instituto de Pesquisa Clínica em Campinas

Campinas, São Paulo, Brazil

Site Status

Universidade de Sao Paulo (USP) - Hospital das Clinicas da F

Cerqueira Cesar - Sao Paulo, São Paulo, Brazil

Site Status

IPEC-Instituto de Pesquisa Clinica

São Paulo, São Paulo, Brazil

Site Status

CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, Brazil

Site Status

Instituto de Estudos e Pesquisas Clínicas do Ceará - IEP/CE - Oncology

Fortaleza, , Brazil

Site Status

MHAT Yuliya Vrevska Byala

Byala, , Bulgaria

Site Status

MHAT Dobrich AD

Dobrich, , Bulgaria

Site Status

MHAT Dr. Tota Venkova AD

Gabrovo, , Bulgaria

Site Status

UMHAT - Kaspela- EOOD

Plovdiv, , Bulgaria

Site Status

Medical Center Asklepion - Humane Medicine Research EOOD

Sofia, , Bulgaria

Site Status

Alexandrovska University Hospital

Sofia, , Bulgaria

Site Status

University of Calgary

Calgary, Alberta, Canada

Site Status

Alberta Diabetes Institute

Edmonton, Alberta, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Eastern Health

St. John's, Newfoundland and Labrador, Canada

Site Status

South Shore Medical Arts

Bridgewater, Nova Scotia, Canada

Site Status

Dr. Anil K. Gupta Medicine Professional Corporation

Etobicoke, Ontario, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Site Status

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

Site Status

Toronto Liver Centre

Toronto, Ontario, Canada

Site Status

CISSS de la Monteregie-Centre

Greenfield Park, Quebec, Canada

Site Status

Recherche GCP Research

Montreal, Quebec, Canada

Site Status

Centre Hospitalier de l'Universite de Montreal - CHUM

Montreal, Quebec, Canada

Site Status

Central Alberta Research Centre

Red Deer, , Canada

Site Status

Toronto Digestive Disease Associates

Vaughan, , Canada

Site Status

Rodrigo Botero S.A.S.

Medellín, Antioquia, Colombia

Site Status

Centro Cardiovascular y de Diabetes

Barranquilla, Atlántico, Colombia

Site Status

Fundación BIOS

Barranquilla, Atlántico, Colombia

Site Status

Endocare Ltda.

Bogota, Cundinamarca, Colombia

Site Status

Healthy Medical Center

Zipaquirá, Cundinamarca, Colombia

Site Status

Medplus Medicina Prepagada

Bogotá, Distrito Capltal, Colombia

Site Status

Centro Medico Imbanaco de Cali S.A.

Cali, Distrito Capltal, Colombia

Site Status

IPS Centro Medico Julian Coronel S.A

Cali, Valle del Cauca Department, Colombia

Site Status

Gastroenheden, Hvidovre hospital

Hvidovre, Kobenhavn, Denmark

Site Status

Aalborg University Hospital

Aalborg, , Denmark

Site Status

Steno Diabetes Center Copenhagen

Hellerup, , Denmark

Site Status

Nordsjaellands Hospital

Hilleroed, , Denmark

Site Status

MEA KFA

Aarhus, Århus, Denmark

Site Status

CHU de Bordeaux - Hôpital Haut-Lévêque

Pessac, Gironde, France

Site Status

Hôpital Louis-Mourier

Colombes, , France

Site Status

Corbeil Essonnes

Corbeil-Essonnes, , France

Site Status

Service d'hépato-gastroentérologie - 7°D

Grenoble, , France

Site Status

Hospices Civils de Lyon - Hôpital Edouard Herrriot

Lyon, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

Hopital Charles Nicolle

Rouen, , France

Site Status

CHRU Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Centre de Recherche Clinique

Vénissieux, , France

Site Status

Klinische Forschung Karlsruhe GmbH

Karlsruhe, Baden-Wurttemberg, Germany

Site Status

Praxis Dr. Etzrodt-Walter und Kollegen

Ulm, Baden-Wurttemberg, Germany

Site Status

Klinische Forschung Schwerin GmbH

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status

Diabetologische Schwerpunktpraxis

Bad Berleburg, North Rhine-Westphalia, Germany

Site Status

Klinische Forschung Dresden GmbH

Dresden, Saxony, Germany

Site Status

Studienzentrum Schwittay

Böhlen, , Germany

Site Status

Universitätsklinikum Giessen und Marburg GmbH

Giessen, , Germany

Site Status

Klinische Forschung Hamburg GmbH

Hamburg, , Germany

Site Status

Clinical Research Hamburg GmbH

Hamburg, , Germany

Site Status

Israelitisches Krankenhaus

Hamburg, , Germany

Site Status

Klinische Forschung Hannover-Mitte GmbH

Hanover, , Germany

Site Status

KRH Klinikum Siloah

Hanover, , Germany

Site Status

Markhot Ferenc Oktatokorhaz es Rendelointezet

Eger, Heves County, Hungary

Site Status

Coromed SMO

Pécs, Pécs, Hungary

Site Status

First Department of Medicine, University of Szeged

Szeged, Szaged, Hungary

Site Status

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, Zala County, Hungary

Site Status

Semmelweis University

Budapest, , Hungary

Site Status

Stra¡zshegy Medicina

Budapest, , Hungary

Site Status

Hetenyi Geza Hospital

Szolnok, , Hungary

Site Status

King George Hospital

Visakhapatnam, Andhra Pradesh, India

Site Status

Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Res

Ahmedabad, Gujarat, India

Site Status

Zydus Hospital

Ahmedabad, Gujarat, India

Site Status

Surat Institute of Digestive Sciences Hospitals

Surat, Gujarat, India

Site Status

Lifecare Clinic and Research Centre - Internal Med/Diabetolo

Bangalore, Karnataka, India

Site Status

Diacon Hospital and research Center

Bengaluru, Karnataka, India

Site Status

Victoria Hospital Bangalore Medical College and Research Ins

Bengaluru, Karnataka, India

Site Status

Rajalakshmi Hospital

Bengaluru, Karnataka, India

Site Status

Vinaya Hospital & Research Centre

Mangalore, Karnataka, India

Site Status

Chopda Medicare & Research Centre Pvt.Ltd, Magnum Heart Institute

Nashik, Maharashtra, India

Site Status

B. J. Government Medical College and Sassoon General Hospitals

Pune, Maharashtra, India

Site Status

Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, India

Site Status

University Hospital

Pune, Maharashtra, India

Site Status

Noble Hospital

Pune, Maharashtra, India

Site Status

S.P.Medical College & Group of Hospitals Bikaner

Bikaner, Rajasthan, India

Site Status

S.R. Kalla Memorial Gastro and General Hospital

Jaipur, Rajasthan, India

Site Status

Sawai Man Singh Hospital

Jaipur, Rajasthan, India

Site Status

Sir Ganga Ram Hospital (SGRH)

Jaipur, Rajasthan, India

Site Status

Marudhar Hospital

Jaipur, Rajasthan, India

Site Status

Eternal Hospital, Unit of Eternal Heart Care Centre and Research Institute Pvt. Ltd.

Jaipur, Rajasthan, India

Site Status

Madras Medical College & Rajiv Gandhi Govt. General Hospital

Chennai, Tamil Nadu, India

Site Status

M.V. Hospital for Diabetes & Diabetes Research Centre

Chennai, Tamil Nadu, India

Site Status

Kovai Diabetes Speciality Centre

Coimbatore, Tamil Nadu, India

Site Status

Arthur Asirvatham Hospital

Madurai, Tamil Nadu, India

Site Status

M V Hospital & Research Centre

Lucknow, Uttar Pradesh, India

Site Status

IPGME&R and SSKM Hospital

Kolkata, West Bengal, India

Site Status

M. S. Ramaiah medical College and Hospitals - Gastroenterolo

Bangalore, , India

Site Status

Gleneagles Global Hospital

Hyderabad, , India

Site Status

Kumudini Devi Diabetes Research Center

Hyderabad, , India

Site Status

Bhatia Hospital

Mumbai, , India

Site Status

Soroka University Medical Center

Beersheba, , Israel

Site Status

Bnai Zion M.C.

Haifa, , Israel

Site Status

E. Wolfson Medical Center

Holon, , Israel

Site Status

Digestive Diseases Institute

Jerusalem, , Israel

Site Status

Gastroenterology Institute

Petah Tikva, , Israel

Site Status

Endocrinology & Diabetes Center

Safed, , Israel

Site Status

Gastroenterology Institute

Tel Aviv, , Israel

Site Status

IRCCS Policlinico San Donato

San Donato Milanese, Milan, Italy

Site Status

Clinical Institute Beato Matteo

Vigevano, Pavia, Italy

Site Status

Policlinico Gemelli, Divisione di Endocrinologia e Malattie del Metabolismo

Rome, Rome Roma, Italy

Site Status

Ospedale Cardinal Massaia

Asti, , Italy

Site Status

University of Bari

Bari, , Italy

Site Status

Azienda Ospedaliera Rilievo Nazionale Alta Specialita (ARNAS) Garibaldi

Catania, , Italy

Site Status

Universita Magna Graecia di Catanzaro

Catanzaro, , Italy

Site Status

IRCCS Azienda Ospedaliera Universitaria San Martino

Genova, , Italy

Site Status

Universita degli Studi di Napoli Federico II

Napoli, , Italy

Site Status

Azienda Opsedaliera di Padova

Padua, , Italy

Site Status

IRCCS S.Matteo Hospital Foundation, University of Pavia

Pavia, , Italy

Site Status

University of Pisa - Cisanello Hospital

Pisa, , Italy

Site Status

Gruppo Humanitas - Humanitas Research Hospital

Rozzano, , Italy

Site Status

Universita' Di Salerno- Aou Ruggi D'aragona

Salerno, , Italy

Site Status

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status

Polana-D

Daugavpils, , Latvia

Site Status

Ogorelova Jelena GP

Krāslava, , Latvia

Site Status

Pauls Stradins Clinical University Hospital, Endokrinologijas nodala

Riga, , Latvia

Site Status

Digestive Diseases Centre GASTRO

Riga, , Latvia

Site Status

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Site Status

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Universiti Sains Malaysia

Kubang Kerian, , Malaysia

Site Status

Hospital Taiping

Taiping, , Malaysia

Site Status

Centro de Investigacion Morales Vargas - CIMOVA

León, Guanajuato, Mexico

Site Status

Centro de Diabetes de Pachuca

Pachuca, Hidalgo, Mexico

Site Status

Unidad de Investigación Clínica Cardiometabolica de Occidente

Guadalajara, Jalisco, Mexico

Site Status

Consultorio Medico

Guadalajara, Jalisco, Mexico

Site Status

Unidad de Investigación clínica y atención Médica HEPA S.C.

Guadalajara, Jalisco, Mexico

Site Status

Clinicos Asociados BOCM SC

Mexico City, Mexico City, Mexico

Site Status

Clinica OMEGA

Mexico City, Mexico City, Mexico

Site Status

Instituto Nacional de Ciencias Medicas y Nutricion

Mexico City, Mexico City, Mexico

Site Status

Medical and Nutritional Trials

México DF, Mexico City, Mexico

Site Status

Instituto de Diabetes Obesidad y Nutrición SC

Cuautla, Morelos, Mexico

Site Status

Accelerium Clinical Research

Monterrey, Nuevo León, Mexico

Site Status

Centro Medico Christus Muguerza Sur

Monterrey, Nuevo León, Mexico

Site Status

Investigación Médica Sonora, S.C.

Hermosillo, Sonora, Mexico

Site Status

Centro Especializado en Investigación Clínica S.C.

Boca del Rio, Veracruz, Mexico

Site Status

Centro de Desarrollo Biomédico

Mérida, Yucatán, Mexico

Site Status

Practice Dr Gerardo Gonzalez

Acapulco, , Mexico

Site Status

Hospital Cardiológica Aguascalientes

Aguascalientes, , Mexico

Site Status

Dioderm Instituto de Investigación

Durango, , Mexico

Site Status

CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)

Durango, , Mexico

Site Status

Sociedad de Metabolismo y Corazón, S.C.

Veracruz, , Mexico

Site Status

Perpetual Succor Hospital

Cebu City, , Philippines

Site Status

West Visayas State University Medical Center

Iloilo City, , Philippines

Site Status

Ospital ng Makati

Makati City, , Philippines

Site Status

Manila Doctors Hospital

Manila, , Philippines

Site Status

San Juan De Dios Educational Foundation, Inc.

Pasay, , Philippines

Site Status

St. Luke's Medical Center

Quezon City, , Philippines

Site Status

Cardinal Santos Medical Center

San Juan City, , Philippines

Site Status

NZOZ Vita - Diabetica Malgorzata Buraczyk, Diabetes Clinic,

Bialystok, Bia|ystok, Poland

Site Status

Centrum Medyczne Pratia Warszawa

Warsaw, Warazawa, Poland

Site Status

Szpital Uniwestytetu Medycznego w Bialymstoku

Bialystok, , Poland

Site Status

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, , Poland

Site Status

Vitamed

Bydgoszcz, , Poland

Site Status

Centrum Medyczne Lukamed

Chojnice, , Poland

Site Status

Silmedic Sp z o o

Katowice, , Poland

Site Status

Specjalistyczny Gabinet Neurologiczny Marta Banach

Krakow, , Poland

Site Status

CenterMed Krakow Ltd

Krakow, , Poland

Site Status

Centrum Medyczne Medyk

Lublin, , Poland

Site Status

Wojewodzki Szpital Specjalistyczny w Olsztynie

Olsztyn, , Poland

Site Status

Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer sp. Z o.o.

Pruszków, , Poland

Site Status

Endoskopia SP. Z O.O.

Sopot, , Poland

Site Status

Powiatowe Centrum Medyczne w Wołowie

Wołów, , Poland

Site Status

Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

Wroclaw, , Poland

Site Status

Zamość

Zamość, , Poland

Site Status

Sana Medical Center

Bucharest, , Romania

Site Status

National Institute of Endocrinology

Bucharest, , Romania

Site Status

AMES Research Center SRL

Călăraşi, , Romania

Site Status

ClinTrial Medical Center, Pulmonology Department

Dobrosloveni Resca, Olt County, , Romania

Site Status

Polisano-Clinic

Sibiu, , Romania

Site Status

Scientific Institute of Clinical and Experimental Lymphology

Novosibirsk, Novosibirsk Oblast, Russia

Site Status

North-Western State Medical University named after I. I. Mechnikov

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Millitary-medical Academy, department of hospital therapy

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Kazan State Medical University

Kazan', , Russia

Site Status

Saint-Petersburg City Pokrovskaya Hospital

Leningrad Region, , Russia

Site Status

FSBI National medical endocrinology research centre

Moscow, , Russia

Site Status

Moscow Regional Research Clinical Institute named by MF Vladimirski

Moscow, , Russia

Site Status

Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko

Nizhny, , Russia

Site Status

Rostov on Don

Rostov-on-Don, , Russia

Site Status

Rostov State Medical University

Rostov-on-Don, , Russia

Site Status

MUZ City Clinical Hospital 9

Saratov, , Russia

Site Status

Saratov City Clinical Hospital 12

Saratov, , Russia

Site Status

National University Hospital

Singapore, , Singapore

Site Status

Singapore General Hospital

Singapore, , Singapore

Site Status

Changi General Hospital

Singapore, , Singapore

Site Status

FARMOVS

Bloemfontein, Free State, South Africa

Site Status

Soweto CTC

Johannesburg, Gauteng, South Africa

Site Status

Wits Clinical Research

Johannesburg, Gauteng, South Africa

Site Status

Synexus Stanza Clincal Reaserch Centre

Pretoria, Gauteng, South Africa

Site Status

Endocare Research

Paarl, Western Cape, South Africa

Site Status

Synexus Helderberg Clinical Research Centre

Cape Town, , South Africa

Site Status

TREAD Research

Cape Town, , South Africa

Site Status

Syenxus Watermeyer Dedicated Research

Val de Grace, , South Africa

Site Status

Moriana Clinical Research

Winnie Mandela, , South Africa

Site Status

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Sanggye Paik Hospital, Inje University College of Medicine

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Clinico Universitario San Carlos

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Universitario Principe de Asturias

Madrid, , Spain

Site Status

Hospital Clinico Universitario de Salamanca

Salamanca, , Spain

Site Status

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status

Phramongkutklao Hospital

Bangkok, , Thailand

Site Status

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, , Thailand

Site Status

State Institution Ukrainian State Research Institute

Dnipro, Dnipropetrovsk Oblast, Ukraine

Site Status

"Kryvyi Rih City Hospital #3" of Dnipropetrovsk Regional Council

Dnipropetrovsk Region, Dnipropetrovsk Oblast, Ukraine

Site Status

Ivano-Frankivsk National Medical University

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Site Status

Kyiv city clinical endocrinology center, department of general endocrine pathology and metabolism, c. Kyiv

Kyiv, Kyïv, Ukraine

Site Status

DRRI-Vinnytsia National Pirogov Memorial Medical University

Vinnytsia, Vinnytsia Oblast, Ukraine

Site Status

Municipal Institution Lutsk City Clinical Hospital

Lutsk, Volyos'ka Oblast', Ukraine

Site Status

Municipal nonprofit entity "Chernigiv city hospital #2" of Chernigiv municipal council, therapeutic department

Chernihiv, , Ukraine

Site Status

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

Site Status

Regional Public Organization Chernivtsi Regional Endocrinology Center

Chernivtsi, , Ukraine

Site Status

SU Clinic of medical academy of SI Dnepropetrovsk medical cacadamy of MoH of Ukraine

Dnipro, , Ukraine

Site Status

Ivano-Frankivsk Central City Clinical Hospital

Ivano-Frankivsk, , Ukraine

Site Status

Municipal nonprofit entity "City clinical hospital #2 n.a. Prof.O.O.Shalimov" of Kharkiv municipal council, department of endocrinology

Kharkiv, , Ukraine

Site Status

"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

Site Status

Clinical Endocrinology of SI V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine

Kharkiv, , Ukraine

Site Status

Communal Institution Kherson City Clinical Hospital

Kherson, , Ukraine

Site Status

Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv

Kyiv, , Ukraine

Site Status

Kyiv Railway Clinical Hospital #2 of Branch Healthcare Center of the PJSC Ukranian Railway, Endocrynology Department

Kyiv, , Ukraine

Site Status

Medical Center Universal Clinic OberigMedical Center Universal Clinic Oberig / Medical Center "Universal Clininc "Oberig" of LLC "Capital", Gastroenterological Center, c. Kyiv

Kyiv, , Ukraine

Site Status

Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit

Kyiv, , Ukraine

Site Status

Institute of Endocrinology and Metabolism im. V. P. Komisarenka NAMS Ukraine

Kyiv, , Ukraine

Site Status

City Hospital #1, department of endocrinology, c. Mykolayiv

Mykolaiv, , Ukraine

Site Status

Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University

Odesa, , Ukraine

Site Status

Communal Institution "Odesa Regional Clinical Hospital", Out-patient department

Odesa, , Ukraine

Site Status

Poltava Regional Clinical Hospital

Poltava, , Ukraine

Site Status

Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital

Sumy, , Ukraine

Site Status

Ternopil University Hospital, Regional Center for Gastroenterology with Hepatology, Department of Gastroenterology

Ternopil, , Ukraine

Site Status

Private Small-Scale Enterprise Medical Center Pulse

Vinnytsia, , Ukraine

Site Status

Medical Center of the Limited Liability Company "Health Clinic", Medical Clinical Research Center, Department of Gastroenterology, Hepatology and Endocrinology

Vinnytsia, , Ukraine

Site Status

Vinnytsia Regional Clinical highly specialized Endocrinology Centre

Vinnytsia, , Ukraine

Site Status

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

Site Status

6th City Clinical Hospital, c. Zaporizhzhia

Zaporizhzhia, , Ukraine

Site Status

"Municipal Institution ""City Hospital #7"", polyclinic department, c. Zaporizhzhia"

Zaporizhzhia, , Ukraine

Site Status

Municipal Institution-Zaporizhzhia Regional Clinical Hospital

Zaporizhzhia, , Ukraine

Site Status

Royal Oldham Hospital

Oldham, Lancashire, United Kingdom

Site Status

MAC Research, Exchange House

Cannock, Staffordshire, United Kingdom

Site Status

University Hospitals of North Midlands

Stoke-on-Trent, Staffordshire, United Kingdom

Site Status

MAC Research

Barnsley, , United Kingdom

Site Status

MAC Clinical Research, Kaman Court

Blackpool, , United Kingdom

Site Status

Mid Essex Hospital Services NHS Trust Broomfield Hospital

Chelmsford, , United Kingdom

Site Status

Western General Hospital Edinburgh

Edinburgh, , United Kingdom

Site Status

MAC Clinical Research, Monarch House

Leeds, , United Kingdom

Site Status

MAC Clinical Research

Liverpool, , United Kingdom

Site Status

Wingate Institute

London, , United Kingdom

Site Status

University College London Hospita

London, , United Kingdom

Site Status

MAC Clinical Research Manchester

Manchester, , United Kingdom

Site Status

University Hospital of South Manchester

Manchester, , United Kingdom

Site Status

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, , United Kingdom

Site Status

Biomedical Research Centre

Nottingham, , United Kingdom

Site Status

MAC Clinical Research, GAC House

Stockton-on-Tees, , United Kingdom

Site Status

St George's Hospital

Tooting, , United Kingdom

Site Status

Royal Wolverhampton NHS Trust

Wolverhampton, , United Kingdom

Site Status

Countries

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Saudi Arabia United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Colombia Denmark France Germany Hungary India Israel Italy Latvia Malaysia Mexico Philippines Poland Romania Russia Singapore South Africa South Korea Spain Thailand Ukraine United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-000406-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3071-305-020

Identifier Type: -

Identifier Source: org_study_id