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Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis Study 02

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03426345
Recruitment Status : Active, not recruiting
First Posted : February 8, 2018
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.

Condition or disease Intervention/treatment Phase
Gastroparesis Diabetes Mellitus Drug: Relamorelin Drug: Placebo Phase 3

Detailed Description:
Active, not recruiting due to COVID-19

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Actual Study Start Date : February 16, 2018
Estimated Primary Completion Date : September 21, 2021
Estimated Study Completion Date : September 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Relamorelin 10μg
Relamorelin 10μg injected subcutaneously twice daily for 12 weeks.
Drug: Relamorelin
Relamorelin 10μg injected twice daily for 12 weeks.

Placebo Comparator: Placebo
Placebo injected twice daily for 12 weeks.
Drug: Placebo
Placebo injected twice daily for 12 weeks.




Primary Outcome Measures :
  1. To compare the efficacy of relamorelin with placebo in participants with respect to their diabetic gastroparesis symptoms during the 12 weeks of treatment [ Time Frame: Baseline to Week 12 ]
    Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.

  2. Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment [ Time Frame: Baseline to Week 12 ]
    Vomiting episodes will be patient-recorded daily using an electronic diary.


Secondary Outcome Measures :
  1. Percentage of Patients Meeting the Nausea Responder Criterion [ Time Frame: Baseline to Week 12 ]
    A Nausea Responder is defined as an improvement of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.

  2. Percentage of Patients Meeting the Abdominal Pain Responder Criterion [ Time Frame: Baseline to Week 12 ]
    An Abdominal Pain Responder is defined as an improvement of at least 2-points in the weekly symptom scores for Abdominal Pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal pain, and 10 meaning the worst possible abdominal pain.

  3. Percentage of Patients Meeting the Bloating Responder Criterion [ Time Frame: Baseline to Week 12 ]
    A Bloating Responder is defined as an improvement of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.

  4. Percentage of Patients Meeting the Postprandial Fullness Responder Criterion [ Time Frame: Baseline to Week 12 ]
    A Postprandial Fullness Responder is defined as an improvement of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.

  5. Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE) [ Time Frame: Baseline to Week 12 ]
    The number of patients who experienced one or more TEAE during the 12 week treatment period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Type 1 or Type 2 diabetes mellitus
  • Meet the per protocol criteria of diabetic gastroparesis
  • Compliance with diary
  • Compliance with the per protocol study treatment dosing instructions

Exclusion Criteria:

  • Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426345


Locations
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United States, Alabama
North Alabama Research Center, LLC
Athens, Alabama, United States, 35611
Synexus Clinical Research US - Simon Williamson Clinic
Birmingham, Alabama, United States, 35211
G & L Research, LLC
Foley, Alabama, United States, 36535
Alabama Medical Group, PC
Mobile, Alabama, United States, 36608
United States, Arizona
Adobe Clinical Research LLC
Tucson, Arizona, United States, 85712
Synexus Clinical Research US, Inc.
Tucson, Arizona, United States, 85741
United States, Arkansas
Applied Research Center of Arkansas
Little Rock, Arkansas, United States, 72212
Unity Health - Searcy Medical Center
Searcy, Arkansas, United States, 72143
United States, California
HCP Clinical Research LLC
Anaheim, California, United States, 92801
GW Research Inc
Chula Vista, California, United States, 91910
Southern California Research Center
Coronado, California, United States, 92118
Diagnamics Inc.
Encinitas, California, United States, 92024
Fresno Clinical Research Center
Fresno, California, United States, 93720
Torrance Clinical Research Institute, Inc.
Lomita, California, United States, 90717
Tibor Rubin VA Medical Center
Long Beach, California, United States, 90822
Angel City Research Inc.
Los Angeles, California, United States, 90057
Facey Medical Foundation
Mission Hills, California, United States, 91345
United Medical Doctors
Murrieta, California, United States, 92563
Stanford Hospital
Palo Alto, California, United States, 94304
TriWest Research Associates
Poway, California, United States, 92064
Optimal Research California
San Diego, California, United States, 92108
Care Access Research
San Pablo, California, United States, 94806
Syrentis Clinical Research
Santa Ana, California, United States, 92705
New Hope Research Development
Whittier, California, United States, 90603
United States, Colorado
Synexus / Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
Colorado Springs, Colorado, United States, 80909
Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
Gastroenterology Associates of Fairfield County, P.C.
Bridgeport, Connecticut, United States, 06606
United States, Florida
Visionary Investigators Network
Aventura, Florida, United States, 33180
Leonard J. Dunn, MD
Clearwater, Florida, United States, 33765
ALL Medical Research LLC
Cooper City, Florida, United States, 33024
Palmetto Research, LLC
Hialeah, Florida, United States, 33016
Vida Clinical Trials
Homestead, Florida, United States, 33030
UF Health Jacksonville - Gastroenterology Emerson
Jacksonville, Florida, United States, 32207
Panax Clinical Research, LLC.
Miami Lakes, Florida, United States, 33014
Sanchez Clinical Research, Inc.
Miami, Florida, United States, 33157
Gastroenterology Group of Naples
Naples, Florida, United States, 34102
Synexus
Pinellas Park, Florida, United States, 33781
Cleveland Clinic Florida - Weston
Weston, Florida, United States, 33331
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Emory University
Atlanta, Georgia, United States, 30322
River Birch Research Alliance, LLC
Blue Ridge, Georgia, United States, 30513
Gwinnett Research Institute
Buford, Georgia, United States, 30519
iResearch Atlanta LLC
Decatur, Georgia, United States, 30030
Clinical Research Consultants of Atlanta
Suwanee, Georgia, United States, 30024
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center, PA
Idaho Falls, Idaho, United States, 83404-7596
United States, Illinois
Synexus Clinical Research US, Inc.
Chicago, Illinois, United States, 60602
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
North Shore University Health System
Evanston, Illinois, United States, 60201
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
United States, Indiana
American Research, LLC
Jeffersonville, Indiana, United States, 47130
Gastroenterology of Southern Indiana
New Albany, Indiana, United States, 47150
United States, Iowa
Integrated Clinical Trial Services Inc
West Des Moines, Iowa, United States, 50265
United States, Kansas
Health Science Research Center
Pratt, Kansas, United States, 67124
WestGlen Gastrointestinal Consultants
Shawnee Mission, Kansas, United States, 66217
Kansas Medical Clinic
Topeka, Kansas, United States, 66606
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States, 67205
Via Christi Clinic, PA
Wichita, Kansas, United States, 67208
United States, Kentucky
Tri-State Gastroenterology
Crestview Hills, Kentucky, United States, 41017
Gastroenterology Associates of Hazard
Hazard, Kentucky, United States, 41701
United States, Louisiana
WK Physicians Network
Bossier City, Louisiana, United States, 71111
Avant Research Associates LLC
Crowley, Louisiana, United States, 70526
Centex Studies, Inc. - Lake Charles
Lake Charles, Louisiana, United States, 70601
Clinical Trials of SWLA, LLC / Centex Studies, Inc. - Lake Charles
Lake Charles, Louisiana, United States, 70601
Tandem Clinical Research
Marrero, Louisiana, United States, 70072
Clinical Trials of America, Inc.
West Monroe, Louisiana, United States, 71291
United States, Maryland
Trialspark - Sood
Bowie, Maryland, United States, 20716
Capital Diabetes and Endocrine Associates
Camp Springs, Maryland, United States, 20746
Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Woodholme Gastroenterology Associates, P.A.
Glen Burnie, Maryland, United States, 21061
Meritus Center for Clinical Research
Hagerstown, Maryland, United States, 21742
Meridian Clinical Research, LLC
Rockville, Maryland, United States, 20854
Capitol Research
Rockville, Maryland, United States, 20879
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Commonwealth Clinical Studies, PLLC.
Brockton, Massachusetts, United States, 02302
Coastal Research Associates, Inc.
South Weymouth, Massachusetts, United States, 02190
United States, Michigan
Clinical Research Institute of Michigan
Chesterfield, Michigan, United States, 48047
Aa Mrc, Llc
Flint, Michigan, United States, 48504
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Synexus Clinical Research US, Inc
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Heartland Clinical Research, Inc
Omaha, Nebraska, United States, 68134
United States, New Jersey
USMA Clinical Research, LLC
Elizabeth, New Jersey, United States, 07201
United States, New Mexico
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States, 87108
United States, New York
Trialspark - Silverman
Forest Hills, New York, United States, 11375
Queens Hospital Center
Jamaica, New York, United States, 11432
Synexus Clinical Research US, Inc.
Jamaica, New York, United States, 11432
Winthrop-University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
Carolina Digestive Health Associates, PA
Davidson, North Carolina, United States, 28036
Kinston Medical Specialists, P.A.
Kinston, North Carolina, United States, 28501
Vidant Multispeciality Clinic - Kinston
Kinston, North Carolina, United States, 28501
Diabetes and Endocrinology Consultants, PC
Morehead City, North Carolina, United States, 28557
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Synexus Clinical Research US, Inc.
Akron, Ohio, United States, 44311
Diabetes & Endocrinology Associates of Stark County, Inc.
Canton, Ohio, United States, 44718
Synexus Clinical Research US - Cincinnati
Cincinnati, Ohio, United States, 45236
Synexus Clinical Research US, Inc
Cincinnati, Ohio, United States, 45249
The MetroHealth System MHS
Cleveland, Ohio, United States, 44109-1998
Digestive Disease & Surgery Institute
Cleveland, Ohio, United States, 44195
The Ohio State University, Wexner Medical Center
Columbus, Ohio, United States, 43203
Aventiv Research, Inc.
Columbus, Ohio, United States, 43213
Clinical Inquest Center Ltd.
Dayton, Ohio, United States, 45409
Hometown Urgent Care and Research
Dayton, Ohio, United States, 45424
United States, Oklahoma
Centennial Health-Synexus
Oklahoma City, Oklahoma, United States, 73111
Options Health Research, LLC
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States, 15212
Guthrie Clinical Research
Sayre, Pennsylvania, United States, 18840
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States, 15683
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States, 15401
United States, Rhode Island
Partners in Clinical Research, LLC
Cumberland, Rhode Island, United States, 02864
Care Access Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Synexus Clinical Research US, Inc.
Anderson, South Carolina, United States, 29621
Clinical Trials of South Carolina
Charleston, South Carolina, United States, 29406
United States, South Dakota
Health Concepts
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Clinsearch
Chattanooga, Tennessee, United States, 37421
Gastro One
Germantown, Tennessee, United States, 38138
East Tennessee Research Institute
Johnson City, Tennessee, United States, 37604
United States, Texas
Texas Clinical Research Institute, LLC
Arlington, Texas, United States, 76012
ClinRx Research, LLC
Carrollton, Texas, United States, 75007
Texas Tech University Health Sciences, Center Division of Gastroenterology
El Paso, Texas, United States, 79905
Baylor College of Medicine Medical Center
Houston, Texas, United States, 77030
Biopharma Informatic Inc., Research Center
Houston, Texas, United States, 77043
Houston Endoscopy and Research Center, Inc.
Houston, Texas, United States, 77079
Rodriguez Clinical Trials
Houston, Texas, United States, 77083
Sante Clinical Research
Kerrville, Texas, United States, 78028
Pri-Med Care
Lewisville, Texas, United States, 75067
Pinnacle Clinical Research
San Antonio, Texas, United States, 78215
Synexus Clinical Research US, Inc.
San Antonio, Texas, United States, 78229
Digestive & Liver Disease Center of San Antonio, PLLC
San Antonio, Texas, United States, 78233
Digestive & Liver Disease
San Antonio, Texas, United States, 78233
Dwayne O. Williams MD
Sugar Land, Texas, United States, 77479
United States, Virginia
Blue Ridge Medical Research
Lynchburg, Virginia, United States, 24502
Manassas Clinical Research Centre
Manassas, Virginia, United States, 20110
VA Medical Center McGuire VAMC
Richmond, Virginia, United States, 23249
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Washington Gastroenterology PLLC
Tacoma, Washington, United States, 98405
Argentina
Maffei Centro Medico-Investigacion Clinica Aplicada
C.a.b.a., Buenos Aires Province, Argentina, C1425AGC
CIAD Moron
Caba, Buenos Aires Province, Argentina, G4230XAI
CIMEL
Lanus, Buenos Aires Province, Argentina, 1824
DIM Clinica Privada
Ramos Mejia, Buenos Aires Province, Argentina, 1704
Centro de Investigaciones Medicas Mar del Plata SRL
Mar del Plata, Buenos Aires, Argentina, B7600FYK
Consultorios Asociados de Endocrinologia e Investigacion Cl
Buenos Aires, Ciudad Autonoma De Buenos Aire, Argentina, C1425AGC
Instituto Privado de Investigaciones Clínicas de Córdoba
Córdoba, Cordoba, Argentina, X5000AAW
Instituto de Investigaciones Clinicas de Rosario
Rosario, Santa Fe, Argentina, 2000
Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli
Rosario, Santa Fe, Argentina, S200CFK
Clinica Mayo - Infectious DiseasesClínica Mayo de Urgencias
San Miguel de Tucuman, Tucuman, Argentina, 4000
Hospital Sirio Libanes
Buenos Aires, Argentina, C1419AHN
Sanatorio Guemes
Caba, Argentina, C1180 AAX
CIPREC
Ciudad Autonoma deBuenos Aires, Argentina, 1119
Centro Universitario de Investigacion en Farmacologia Clinic
Corrientes, Argentina, W3410AVV
Instituto de Investigaciones Clinicas Cba
Córdoba, Argentina, X5000AAW
CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian
Córdoba, Argentina, X5000BNB
Austria
Ordination
Saint Stefan, Steiermark, Austria, 8511
Medizinische Universitat Innsbruck
Innsbruck, Tirol, Austria, A-6020
VIVIT Institute, am LKH Feldkirch
Feldkirch, Vorarlberg, Austria, 6807
Klinikum Klagenfurt am Worthersee
Klagenfurt, Austria, 9020
Privatklinik Wehrle-Diakonissen
Salzburg, Austria, 5020
Oo. Gesundheits- und Spitals-AG/LKH Steyr
Steyr, Austria, 4400
Belgium
AZ Sint Lucas Brugge
Brugge, Antwerpen, Belgium, 2650
Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
Edegem, Antwerp, Belgium, 2650
UZ Brussel
Jette, Brussel, Belgium, 1090
CHC - Clinique Saint-Joseph
Liege, Belgium, 4000
Brazil
Hospital Universitario Walter Cantidio
Fortaleza, Ceara, Brazil, 60430-372
Centro de Pesquisa Clinica do Brasil
Brasilia, Distrito Federal, Brazil, 71625175
Quanta Diagnóstico e Terapia
Curitiba, Paraná, Brazil, 80030-110
Hospital Universitario Joao de Barros Barreto
Belem, Para, Brazil, 66073-000
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
Hospital de Clinicas de Porto Alegre/ Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
Hospital Sao Lucas da PUC-RS
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
NOOVA
Florianópolis, Santa Catarina, Brazil, 88015-230
Instituto Catarinense de Endocrinologia e Diabetes (ICED)
Joinville, Santa Catarina, Brazil, 89201-260
Scentryphar Pesquisa Clinica Ltda
Campinas, Sao Paulo, Brazil, 13020-431
Instituto de Pesquisa Clinica em Campinas
Campinas, Sao Paulo, Brazil, 13060-080
Clinica Espec Ima Brasil
Cerqueira Cesar - Sao Paulo, Sao Paulo, Brazil, Cep 05403-000
Clinica Espec Ima Brasil
Cerqueira Cesar, Sao Paulo, Brazil, Cep 05403-000
Instituto de Estudos E Persquisas Clinica Do Ceara IEP/CE - Oncology
Fortaleza, Brazil, 60160-230
CPQuali Pesquisa Clinica Ltda
Sao Paulo, Brazil, 01228-000
Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda
SÃo Paulo, Brazil, 01223-001
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Alberta Diabetes Institute
Edmonton, Alberta, Canada, T6G 2E1
Canada, British Columbia
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Newfoundland and Labrador
Eastern Health
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
South Shore Medical Arts
Bridgewater, Nova Scotia, Canada, B4V 2V6
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9
Sunnybrook Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8
Toronto Liver Centre
Toronto, Ontario, Canada, M6H 3M1
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ontario, Canada, M9V 4B4
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Ontorio
Humber River Hospital
Toronto, Ontorio, Canada, M3M 0B2
Canada, Quebec
CISSS de la Monteregie-Centre
Greenfield Park, Quebec, Canada, J4V 2H1
Recherche GCP Research
Montreal, Quebec, Canada, H1M 1B1
Centre Hospitalier de l'Universite de Montreal - CHUM
Montreal, Quebec, Canada, H2X 0A9
Canada
Central Alberta Research Centre
Red Deer, Canada, T4N 6V7
Colombia
IPS Rodrigo Botero SAS
Medellin, Antioquia, Colombia, 050030
Centro Cardiovascular Colombiano Clínica Santa María
Medellin, Antioquia, Colombia, 050034
Rodrigo Botero S.A.S.
Medellin, Antioquia, Colombia, 50030
Centro Cardiovascular y de Diabetes
Barranquilla, Atlantico, Colombia, 080020
Fundacion Bios
Barranquilla, Atlantico, Colombia, 080020
Asociación Colombiana de Diabetes
Bogotá, Cundinamarca, Colombia, 111311
Healthy Medical Center
Zipaquira, Cundinamarca, Colombia, 250252
Medplus Mp
Bogota, Distrito Capital De Bogotá, Colombia, 110221
Endocare Ltda.
Bogota, Distrito Capital De Bogotá, Colombia, 111111
Fundacion Centro de Investigaciones Clinicas CARDIOMET
Pereira, Risaralda, Colombia, 660002
IPS Centro Medico Julian Coronel S.A
Cali, Valle Del Cauca, Colombia, 760035
Centro Medico Imbanaco de Cali S.A.
Cali, Valle Del Cauca, Colombia, 760042
Clinica Meta
Meta, Colombia, 500001
Denmark
Gastroenheden, Hvidovre hospital
Hvidovre, Copenhagen, Denmark, 2605
Endocrinology, Aalborg University Hospital
Aalborg, Denmark, DK-9000
Center for Clinical Metabolic Research
Hellerup, Denmark, 2900
Germany
Klinische Forschung Karlsruhe GmbH
Karlsruhe, Baden-SWürttemberg, Germany, 76199
Praxis Dr. Etzrodt-Walter und Kollegen
Ulm, Baden-württemberg, Germany, 89073
Klinische Forschung Schwerin GmbH
Schwerin, Mecklenburg Vorpommern, Germany, 19055
Studienzentrum Schwittay
Böhlen, Saxony, Germany, 4564
Klinische Forschung Dresden GmbH
Dresden, Saxony, Germany, 1309
Diabetologische Schwerpunktpraxis
Bad Berleburg, Germany, 57319
Diabetespraxis Prenzlauer
Berlin, Germany, 10409
Emovis GmbH
Berlin, Germany, 10629
Synexus Berlin Clinical Research Centre
Berlin, Germany, 12627
Synexus Clinical Research GmbH
Frankfurt am MAin, Germany, 60313
Clinical Research Unit
Giessen, Germany, 32392
Klinische Forschung Hamburg GmbH
Hamburg, Germany, 20253
Clinical Research Hamburg
Hamburg, Germany, 22143
Israelitisches Krankenhaus
Hamburg, Germany, 22297
Klinische Forschung Hannover-Mitte GmbH
Hannover, Germany, 30159
Klinikum Region Hannover/KRH Siloah
Hannover, Germany, 30459
KRH Klinikum Siloah
Hannover, Germany, 30459
Diabetesinstitut Heidelberg c-o St. Josefskrankenhaus
Heidelberg, Germany, 69115
DRS Leipzig
Leipzig, Germany, 4103
SMO.MD GmbH
Magdeburg, Germany, 39120
Klinikum Bogenhausen
Munich, Germany, 81925
Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, Heves, Hungary, H-3300
BKS Research Kft Synexus AS
Hatvan, Heves, Hungary, 3000
Hetenyi Geza Hospital
Szolnok, Jász-Nagykun-Szolnok, Hungary, H-5004
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, Zala, Hungary, H-8900
Synexus Budapest DRS
Budapest, Hungary, 1036
Strázsahegy Gyógyszertár Medicina
Budapest, Hungary, H1171
SYNEXUS Magyarorszag Kft Debrecen A.S.
Debrecen, Hungary, 4025
Synexus Magyarország kft. Gyula DRS
Gyula, Hungary, 5700
Medifarma-98
Nyíregyháza, Hungary, 4405
Szegedi Tudomanyegyetem
Szeged, Hungary, H-6720
Clinfan Szolgáltató Kft
Szekszard, Hungary, H-7100
Synexus Magyarorszag Kft
Zalaegerszeg, Hungary, 8900
Latvia
Polana-D, LLC
Daugavpils, Latvia, LV5401
Kraslava Hospital
Kraslava, Latvia, 5601
Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
Riga, Latvia, 1002
Digestive Diseases Centre GASTRO
Riga, Latvia, 1006
Riga Health Centre
Riga, Latvia, LV1002
Siguldas Hospital
Sigulda, Latvia, LV2150
Mexico
Clinicos Asociados BOCM SC
Benito Juarez, Distrito Federal, Mexico, 03300
Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology
Mexico, Distrito Federal, Mexico, 11650
Centro de Atención e Investigación en Factores de Riesgo Car
Mexico, Distrito Federal, Mexico, 14000
Centro de Investigacion Morales Vargas - CIMOVA
León, Guanajuato, Mexico, 37000
Morales Vargas Centro de Investigación S.C. (Consultorio ane
León, Guanajuato, Mexico, 37000
CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)
Durango, Guillermina, Mexico, 34270
Centro de Diabetes de Pachuca
Pachuca, Hidalgo, Mexico, 42090
Unidad de Investigacion Clinica Cardiometabolica de Occidente
Guadalajara, Jalisco, Mexico, 44150
Consultorio Medico
Guadalajara, Jalisco, Mexico, 44210
Unidad de Investigación Clínica en Medicina S.C.
Guadalajara, Jalisco, Mexico, 44670
Medical and Nutritional Trials
Distrito Federal, Mexico DF, Mexico, 06700
Mentrials Sa de Cv
Distrito Federal, Mexico DF, Mexico, 06700
Clinica Omega (CAIFRC OMEGA S.C.)
Mexico, Mexico DF, Mexico, 14000
Instituto de Diabetes Obesidad y Nutricion SC
Cuautla, Morelos, Mexico, 62746
Accelerium Clinical Research
Monterrey, Nuevo Leon, Mexico, 64000
Oncologico Potosino
San Luis Potosi, San Luis Potosí, Mexico, 78250
Investigacion Medica Sonora, S.C.
Hermosillo, Sonora, Mexico, 83280
Instituto Nacional de Ciencias Medicas y Nutricion
Tlalpan, Tlalpan C.p., Mexico, 14080
Centro de Desarrollo Biomedico S.C.P.
Mérida, Yucatan, Mexico, 97070
Clínica de Mérida
Mérida, Yucatán, Mexico, 97070
Hospital Universitario "Dr. José E. González" UANL
Acapulco, Mexico, 39350
Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
Aguascalientes, Mexico, 20230
Hospital Cardiologica Aguascalientes
Aguascalientes, Mexico, 20230
Dioderm Instituto de Investigacion
Durango, Mexico, 34060
Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición
Durango, Mexico, 34270
Centro Medico Christus Muguerza Sur
Nuevo Leon, Mexico, 313-315
Centro Especializado en Investigacion Clinica S.C.
Veracruz, Mexico, 34230
Sociedad de Metabolismo y Corazon, S.C.
Veracruz, Mexico, C.P. 91900
Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 927
Romania
ClinTrial Medical Center, Pulmonology Department
Dobrosloveni, Oltenia, Romania, 237143
Sana Medical Center
Bucharest, Romania, 011025
Cabinet Medical De Nutritie Si Boli Metabolice Dr. Nicoleta
Bucharest, Romania, 10507
University Emergency Militare Central Dr.Carol Davila
Bucharest, Romania, 10825
National Institute of Endocrinology
Bucharest, Romania, 11863
Societatea Civila Medicala
Bucharest, Romania, 50538
AMES Research Center SRL
Calarasi, Romania, 910103
Russian Federation
Saint-Petersburg City Pokrovskaya Hospital
St-Petersburg, Leningrad Region, Russian Federation, 199106
GUZ Â"Saratov City Clinical Hospital 9
Saratov, Saratov Region, Russian Federation, 410030
Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko
Nizhny Novgorod, Volga, Russian Federation, 603126
State Budgetary Healthcare Institution Of Arkhangelsk Region Suvorova 1
Arkhangelsk, Russian Federation, 163045
Kazan State Medical University
Kazan, Russian Federation, 420012
FSBI National medical endocrinology research centre
Moscow, Russian Federation, 117036
Moscow Regional Research Clinical Institute named by MF Vladimirski
Moscow, Russian Federation, 129110
Scientific Institute of Clinical and Experimental Lymphology
Novosibirsk, Russian Federation, 630117
Rostov on Don
Rostov on Don, Russian Federation, 344006
Rostov State Medical University
Rostov-on-Don, Russian Federation, 344022
Millitary-medical Academy, department of hospital therapy
Saint-Petersburg, Russian Federation, 191015
North-Western State Medical University named after I. I. Mechnikov
Saint-Petersburg, Russian Federation, 191015
Saratov City Clinical Hospital 12
Saratov, Russian Federation, 410039
South Africa
FARMOVS
Bloemfontein, Free State, South Africa, 9301
Wits Clinical Research
Johannesburg, Gauteng, South Africa, 2193
Synexus Stanza Clincal Reaserch Centre
Pretoria, Gauteng, South Africa, 0122
Watermeyer Clinical Research Site
Silverton, Gauteng, South Africa, 184
Soweto CTC
Soweto, Gauteng, South Africa, 1818
Synexus Helderberg Clinical Research Centre
Cape Town, South Africa, 07130
TREAD Research
Cape Town, South Africa, 7500
Jakaranda Hospital
Pretoria, South Africa, 0002
Ukraine
SU" Clinic of medical academy" of SI "Dnepropetrovsk medical cacadamy of MoH of Ukraine"
Dnipro, Ukraine, 49038
United Kingdom
Queens Medical Centre
Nottingham, East Midland, United Kingdom, NG7 2UH
MAC Clinical Research Manchester
Manchester, Greater Manchester, United Kingdom, M13 9NQ
Synexus Lancashire Dedicated Research Centre
Chorley, Lancashire, United Kingdom, PR7 7NA
Royal Oldham Hospital
Oldham, Lancashire, United Kingdom, OL1 2JH
MAC Research, Exchange House
Cannock, Staffordshire, United Kingdom, WS11 0BH
University Hospitals of North Midlands
Stoke on Trent, Staffordshire, United Kingdom, ST6 8DG
Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
MAC Clinical Research, Monarch House
Leeds, West Yorkshire, United Kingdom, LS10 1DU
MAC Research
Barnsley, United Kingdom, S75 3DL
MAC Clinical Research
Blackpool, United Kingdom, FY2 0JH
Synexus Wales Clinical Research Centre
Cardiff, United Kingdom, CF15 9SS
Mid Essex Hospital Services NHS Trust Broomfield Hospital
Chelmsford, United Kingdom, CM1 7ET
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Synexus Merseyside Dedicated Research Centre
Liverpool, United Kingdom, L22 0LG
MAC Clinical Research
Liverpool, United Kingdom, L34 1BH
University Hospital Aintree
Liverpool, United Kingdom
Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital
London, United Kingdom, E1 2AJ
University College London Hospita
London, United Kingdom, NW1 2BU
Synexus Manchester Clinical Research Centre
Manchester, United Kingdom, M15 6SX
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Royal Victoria Infirmary: Clinical Research Facility
Newcastle upon Tyne, United Kingdom, NE7 7DN
Biomedical Research Centre
Nottingham, United Kingdom, NG7 2UH
MAC Clinical Research, GAC House
Stockton-on-Tees, United Kingdom, TS17 6EW
Synexus Hexham Dedicated Research Centre
Stockton-on-Tees, United Kingdom, TS19 8PE
Synexus North Tees Clinical Research Centre
Stockton-on-Tees, United Kingdom, TS19 8PE
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Wieslaw (Wes) Bochenek, MD, PhD Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03426345    
Other Study ID Numbers: RLM-MD-02
2017-002177-20 ( EudraCT Number )
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms