Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
NCT ID: NCT03426345
Last Updated: 2021-08-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
311 participants
INTERVENTIONAL
2018-02-16
2020-07-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
Placebo
Placebo injected subcutaneously twice daily.
Relamorelin 10 μg
Following a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.
Relamorelin
Relamorelin 10 μg injected twice daily for 12 weeks.
Interventions
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Placebo
Placebo injected subcutaneously twice daily.
Relamorelin
Relamorelin 10 μg injected twice daily for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Meet the per protocol criteria of diabetic gastroparesis
* Compliance with diary
* Compliance with the per protocol study treatment dosing instructions
Exclusion Criteria
* Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1)
* Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
* History of gastrointestinal disorders that may be similar to gastroparesis
* Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Wieslaw (Wes) Bochenek, MD, PhD
Role: STUDY_DIRECTOR
Allergan
Locations
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North Alabama Research Center, LLC
Athens, Alabama, United States
Synexus Clinical Research US - Simon Williamson Clinic
Birmingham, Alabama, United States
G & L Research, LLC
Foley, Alabama, United States
Alabama Medical Group, PC
Mobile, Alabama, United States
Synexus Clinical Research US, Inc.
Tucson, Arizona, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Unity Health - Searcy Medical Center
Searcy, Arkansas, United States
GW Research Inc.
Chula Vista, California, United States
Diagnamics Inc.
Encinitas, California, United States
Fresno Clinical Research Center
Fresno, California, 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
Facey Medical Foundation
Mission Hills, California, United States
United Medical Doctors
Murrieta, California, United States
Stanford Hospital, Digestive Health Clinic
Palo Alto, California, United States
TriWest Research Associates
Poway, California, United States
Optimal Research California
San Diego, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
New Hope Research Development
Whittier, California, United States
Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
Colorado Springs, Colorado, United States
Gastroenterology Associates of Fairfield County, P.C.
Bridgeport, Connecticut, United States
Visionary Investigators Network
Aventura, Florida, United States
Clinical Research of West Florida
Clearwater, Florida, United States
ALL Medical Research LLC
Cooper City, Florida, United States
Palmetto Research, LLC
Hialeah, Florida, United States
Vida Clinical Trials
Homestead, Florida, United States
Sanchez Clinical Research, Inc.
Miami, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Synexus
Pinellas Park, Florida, United States
Cleveland Clinic Florida - Weston
Weston, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, United States
Gwinnett Research Institute, LLC
Buford, Georgia, United States
iResearch Atlanta LLC
Decatur, Georgia, United States
Clinical Research Consultants of Atlanta
Suwanee, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center, PA
Idaho Falls, Idaho, United States
Synexus Clinical Research US, Inc.
Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
North Shore University Health System
Evanston, Illinois, United States
American Research, LLC
Jeffersonville, Indiana, United States
Gastroenterology of Southern Indiana
New Albany, Indiana, United States
Health Science Research Center
Pratt, Kansas, United States
WestGlen Gastrointestinal Consultants
Shawnee Mission, Kansas, United States
Kansas Medical Clinic
Topeka, Kansas, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States
Via Christi Clinic, PA
Wichita, Kansas, United States
Tri-State Gastroenterology
Crestview Hills, Kentucky, United States
WK Physicians Network
Bossier City, Louisiana, United States
Avant Research Associates LLC
Crowley, Louisiana, United States
Clinical Trials of SWLA, LLC
Lake Charles, Louisiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Clinical Trials of America, Inc.
West Monroe, Louisiana, United States
Trialspark - Sood
Bowie, Maryland, United States
Capital Diabetes and Endocrine Associates
Camp Springs, Maryland, United States
Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Woodholme Gastroenterology Associates, P.A.
Glen Burnie, Maryland, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, United States
Meridian Clinical Research, LLC
Rockville, Maryland, United States
Commonwealth Clinical Studies, PLLC.
Brockton, Massachusetts, United States
Clinical Research Institute of Michigan
Chesterfield, Michigan, United States
Aa Mrc Llc
Flint, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Synexus Clinical Research US, Inc
St Louis, Missouri, United States
Heartland Clinical Research, Inc
Omaha, Nebraska, United States
USMA Clinical Research, LLC
Elizabeth, New Jersey, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States
Synexus Clinical Research US, Inc.
Jamaica, New York, United States
Winthrop-University Hospital
Mineola, New York, United States
Carolina Digestive Health Associates, PA
Davidson, North Carolina, United States
Kinston Medical Specialists, P.A.
Kinston, North Carolina, United States
Diabetes and Endocrinology Consultants, PC
Morehead City, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Synexus Clinical Research US, Inc.
Akron, Ohio, United States
Diabetes & Endocrinology Associates of Stark County, Inc.
Canton, Ohio, United States
Synexus Clinical Research US - Cincinnati
Cincinnati, Ohio, United States
Synexus Clinical Research US, Inc
Cincinnati, Ohio, United States
The MetroHealth System MHS
Cleveland, Ohio, United States
Digestive Disease & Surgery Institute
Cleveland, Ohio, United States
The Ohio State University, Wexner Medical Center
Columbus, Ohio, United States
Aventiv Research, Inc.
Columbus, Ohio, United States
CIC America Clinical Inquest Center Ltd.
Dayton, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Centennial Health-Synexus
Oklahoma City, Oklahoma, United States
Options Health Research, LLC
Tulsa, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States
Guthrie Clinical Research
Sayre, Pennsylvania, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Care Access Research
Warwick, Rhode Island, United States
Synexus Clinical Research US, Inc.
Anderson, South Carolina, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
Clinsearch
Chattanooga, Tennessee, United States
Gastro One
Germantown, Tennessee, United States
East Tennessee Research Institute
Johnson City, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
ClinRx Research, LLC
Carrollton, Texas, United States
Baylor College of Medicine Medical Center
Houston, Texas, United States
Biopharma Informatic Inc., Research Center
Houston, Texas, United States
Houston Endoscopy and Research Center, Inc.
Houston, Texas, United States
Rodriguez Clinical Trials
Houston, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
Pinnacle Clinical Research
San Antonio, Texas, United States
Synexus Clinical Research US, Inc.
San Antonio, Texas, United States
Digestive & Liver Disease Center of San Antonio, PLLC
San Antonio, Texas, United States
Dwayne O. Williams MD
Sugar Land, Texas, United States
Blue Ridge Medical Research
Lynchburg, Virginia, United States
Manassas Clinical Research Centre
Manassas, Virginia, United States
VA Medical Center McGuire VAMC
Richmond, Virginia, United States
Washington Gastroenterology PLLC
Tacoma, Washington, United States
Maffei Centro Medico-Investigacion Clinica Aplicada
C.a.b.a., Buenos Aires, Argentina
Hospital Sirio Libanes
CABA, Buenos Aires, Argentina
Centro de Investigaciones Medicas Mar del Plata SRL
Mar del Plata, Buenos Aires, Argentina
Instituto Privado de Investigaciones Clínicas de Córdoba
Córdoba, Córdoba Province, Argentina
Instituto de Investigaciones Clinicas de Rosario
Rosario, Santa Fe Province, Argentina
Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli
Rosario, Santa Fe Province, Argentina
Clinica Mayo - Infectious DiseasesClínica Mayo de Urgencias
San Miguel de Tucumán, Tucumán Province, Argentina
CIPREC
Buenos Aires, , Argentina
Centro Universitario de Investigacion en Farmacologia Clinic
Corrientes, , Argentina
CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian
Córdoba, , Argentina
Ordination
Sankt Stefan, Styria, Austria
VIVIT Institute, am LKH Feldkirch
Feldkirch, Vorarlberg, Austria
Privatklinik Wehrle-Diakonissen
Salzburg, , Austria
Oö. Gesundheits- und Spitals-AG/LKH Steyr
Steyr, , Austria
AZ Sint Lucas Brugge
Bruges, Antwerpen, Belgium
Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
Edegem, Antwerp, Belgium
UZ Brussel
Jette, Brussels Capital, Belgium
Hospital Universitario Walter Cantidio
Fortaleza, Ceará, Brazil
Centro de Pesquisa Clinica do Brasil
Brasília, Federal District, Brazil
Hospital Universitario Joao de Barros Barreto
Belém, Pará, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Catarinense de Endocrinologia e Diabetes (ICED)
Joinville, Santa Catarina, Brazil
Scentryphar Pesquisa Clinica Ltda
Campinas, São Paulo, Brazil
Instituto de Pesquisa Clinica em Campinas
Campinas, São Paulo, Brazil
CPQuali Pesquisa Clinica Ltda
Santa Cecília, São Paulo, Brazil
Instituto de Estudos E Persquisas Clinicas do Ceará - IEP/CE - Oncology
Fortaleza, , Brazil
Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda
São Paulo, , Brazil
University of Calgary
Calgary, Alberta, Canada
Alberta Diabetes Institute
Edmonton, Alberta, Canada
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
Eastern Health
St. John's, Newfoundland and Labrador, Canada
South Shore Medical Arts
Bridgewater, Nova Scotia, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Toronto Digestive Disease Associates
Vaughan, Ontario, Canada
CISSS de la Monteregie-Centre
Greenfield Park, Quebec, Canada
Recherche GCP Research
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal - CHUM
Montreal, Quebec, Canada
Central Alberta Research Centre
Red Deer, , Canada
Centro Cardiovascular Colombiano Clínica Santa María
Medellín, Antioquia, Colombia
Rodrigo Botero S.A.S.
Medellín, Antioquia, Colombia
Centro Cardiovascular y de Diabetes
Barranquilla, Atlántico, Colombia
Fundacion Bios
Barranquilla, Atlántico, Colombia
Medplus Mp
Bogotá, Bogota D.C., Colombia
Endocare Ltda.
Bogotá, Bogota D.C., Colombia
Asociación Colombiana de Diabetes
Bogotá, Cundinamarca, Colombia
Healthy Medical Center
Zipaquirá, Cundinamarca, Colombia
Fundacion Centro de Investigaciones Clinicas CARDIOMET
Pereira, Risaralda Department, Colombia
IPS Centro Medico Julian Coronel S.A
Cali, Valle del Cauca Department, Colombia
Centro Medico Imbanaco de Cali S.A.
Cali, Valle del Cauca Department, Colombia
Gastroenheden, Hvidovre hospital
Hvidovre, Copenhagen, Denmark
Endocrinology, Aalborg University Hospital
Aalborg, , Denmark
Center for Clinical Metabolic Research
Hellerup, , Denmark
Klinische Forschung Karlsruhe GmbH
Karlsruhe, Baden-SWürttemberg, Germany
Studienzentrum Schwittay
Böhlen, Saxony, Germany
Klinische Forschung Dresden GmbH
Dresden, Saxony, Germany
Clinical Research Unit
Giessen, , Germany
Clinical Research Hamburg
Hamburg, , Germany
Israelitisches Krankenhaus
Hamburg, , Germany
KRH Klinikum Siloah
Hanover, , Germany
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, Heves County, Hungary
BKS Research Kft Synexus AS
Hatvan, Heves County, Hungary
Hetenyi Geza Hospital
Szolnok, Jász-Nagykun-Szolnok, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, Zala County, Hungary
Synexus Budapest DRS
Budapest, , Hungary
Strázsahegy Gyógyszertár Medicina
Budapest, , Hungary
SYNEXUS Magyarorszag Kft Debrecen A.S.
Debrecen, , Hungary
Synexus Magyarország kft. Gyula DRS
Gyula, , Hungary
Szegedi Tudomanyegyetem
Szeged, , Hungary
Synexus Magyarorszag Kft
Zalaegerszeg, , Hungary
Polana-D
Daugavpils, , Latvia
Kraslava Hospital
Krāslava, , Latvia
Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
Riga, , Latvia
Digestive Diseases Centre GASTRO
Riga, , Latvia
Unidad de Investigacion Clinica Cardiometabolica de Occidente
Guadalajara, Jalisco, Mexico
Consultorio Medico
Guadalajara, Jalisco, Mexico
Unidad de Investigación Clínica en Medicina S.C.
Guadalajara, Jalisco, Mexico
Medical and Nutritional Trials
Cuauhtémoc, Mexico City, Mexico
Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology
Mexico City, Mexico City, Mexico
Centro de Atención e Investigación en Factores de Riesgo Car
Mexico City, Mexico City, Mexico
Clinicos Asociados BOCM SC
Portales, Mexico City, Mexico
Centro de Desarrollo Biomedico S.C.P.
Mérida, Yucatán, Mexico
Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
Aguascalientes, , Mexico
Hospital Cardiologica Aguascalientes
Aguascalientes, , Mexico
Dioderm Instituto de Investigacion
Durango, , Mexico
Sociedad de Metabolismo y Corazon, S.C.
Veracruz, , Mexico
Saint-Petersburg City Pokrovskaya Hospital
St-Petersburg, Leningradskaya Oblast', Russia
Scientific Institute of Clinical and Experimental Lymphology
Novosibirsk, Novosibirsk Oblast, Russia
GUZ Saratov City Clinical Hospital 9
Saratov, Saratov Oblast, Russia
Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko
Nizhny Novgorod, Volga, Russia
Kazan State Medical University
Kazan', , Russia
FSBI National medical endocrinology research centre
Moscow, , Russia
Moscow Regional Research Clinical Institute named by MF Vladimirski
Moscow, , Russia
Rostov on Don
Rostov-on-Don, , Russia
Rostov State Medical University
Rostov-on-Don, , Russia
North-Western State Medical University named after I. I. Mechnikov
Saint Petersburg, , Russia
Saratov City Clinical Hospital 12
Saratov, , Russia
FARMOVS
Bloemfontein, Free State, South Africa
Wits Clinical Research
Johannesburg, Gauteng, South Africa
Synexus Stanza Clinical Research Centre
Pretoria, Gauteng, South Africa
Watermeyer Clinical Research Site
Silverton, Gauteng, South Africa
Synexus Helderberg Clinical Research Centre
Cape Town, Western Cape, South Africa
TREAD Research
Cape Town, , South Africa
MAC Clinical Research Manchester
Manchester, Greater Manchester, United Kingdom
Synexus Lancashire Dedicated Research Centre
Chorley, Lancashire, United Kingdom
Royal Oldham Hospital
Oldham, Lancashire, United Kingdom
MAC Research, Exchange House
Cannock, Staffordshire, United Kingdom
University Hospitals of North Midlands
Stoke-on-Trent, Staffordshire, United Kingdom
Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom
MAC Clinical Research, Monarch House
Leeds, West Yorkshire, United Kingdom
MAC Research
Barnsley, , United Kingdom
MAC Clinical Research
Blackpool, , United Kingdom
Synexus Wales Clinical Research Centre
Cardiff, , United Kingdom
Mid Essex Hospital Services NHS Trust Broomfield Hospital
Chelmsford, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Synexus Merseyside Dedicated Research Centre
Liverpool, , United Kingdom
MAC Clinical Research
Liverpool, , United Kingdom
Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital
London, , United Kingdom
MAC Clinical Research, GAC House
Manchester, , United Kingdom
Synexus Manchester Clinical Research Centre
Manchester, , United Kingdom
Royal Victoria Infirmary: Clinical Research Facility
Newcastle upon Tyne, , United Kingdom
Biomedical Research Centre
Nottingham, , United Kingdom
Synexus Hexham Dedicated Research Centre
Stockton-on-Tees, , United Kingdom
Synexus North Tees Clinical Research Centre
Stockton-on-Tees, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-002177-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RLM-MD-02
Identifier Type: -
Identifier Source: org_study_id
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