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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03426345
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 20, 2019
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

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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 20, 2018
Estimated Primary Completion Date : January 18, 2020
Estimated Study Completion Date : January 18, 2020

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. Percentage of patients meeting the diabetic gastroparesis symptom responder criterion in each of the last 6 of 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

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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
  • History of an eating disorder (eg, anorexia nervosa, binge-eating, bulimia) in the past 5 years
  • Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
  • History of gastrointestinal disorders that may be similar to gasteroparisis
  • 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


Contacts
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Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@allergan.com

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Locations
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United States, Alabama
North Alabama Research Center, LLC Recruiting
Athens, Alabama, United States, 35611
G & L Research, LLC Recruiting
Foley, Alabama, United States, 36535
Alabama Medical Group, PC Recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Adobe Clinical Research LLC Withdrawn
Tucson, Arizona, United States, 85712
United States, Arkansas
Preferred Research Partners, Inc. Not yet recruiting
Little Rock, Arkansas, United States, 72205
Applied Research Center of Arkansas Recruiting
Little Rock, Arkansas, United States, 72212
Arkansas Gastorenterology Not yet recruiting
North Little Rock, Arkansas, United States, 72117
United States, California
HCP Clinical Research LLC Not yet recruiting
Anaheim, California, United States, 92801
GW Research Inc Recruiting
Chula Vista, California, United States, 91910
Kindred Medical Institute for Clinical Trials, LLC Not yet recruiting
Corona, California, United States, 92879
TriWest Research Associates Recruiting
El Cajon, California, United States, 92020
Diagnamics Inc. Recruiting
Encinitas, California, United States, 92024
Torrance Clinical Research Institute, Inc. Recruiting
Lomita, California, United States, 90717
Tibor Rubin VA Medical Center Not yet recruiting
Long Beach, California, United States, 90822
Angel City Research Inc. Recruiting
Los Angeles, California, United States, 90057
Facey Medical Foundation Recruiting
Mission Hills, California, United States, 91345
Stanford Hospital Not yet recruiting
Palo Alto, California, United States, 94304
Syrentis Clinical Research Not yet recruiting
Santa Ana, California, United States, 92705
New Hope Research Development Not yet recruiting
Whittier, California, United States, 90603
United States, Connecticut
Gastroenterology Associates of Fairfield County, P.C. Not yet recruiting
Bridgeport, Connecticut, United States, 06606
United States, Florida
Visionary Investigators Network Withdrawn
Aventura, Florida, United States, 33180
Leonard J. Dunn, MD Recruiting
Clearwater, Florida, United States, 33765
ALL Medical Research LLC Recruiting
Cooper City, Florida, United States, 33024
Palmetto Research, LLC Recruiting
Hialeah, Florida, United States, 33016
Vida Clinical Trials Recruiting
Homestead, Florida, United States, 33030
Panax Clinical Research, LLC. Not yet recruiting
Miami Lakes, Florida, United States, 33014
Gastroenterology Group of Naples Recruiting
Naples, Florida, United States, 34102
Cleveland Clinic Florida - Weston Not yet recruiting
Weston, Florida, United States, 33331
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Emory University Recruiting
Atlanta, Georgia, United States, 30322
River Birch Research Alliance, LLC Recruiting
Blue Ridge, Georgia, United States, 30513
Gwinnett Research Institute Recruiting
Buford, Georgia, United States, 30519
iResearch Atlanta LLC Recruiting
Decatur, Georgia, United States, 30030
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center, PA Recruiting
Idaho Falls, Idaho, United States, 83404-7596
United States, Illinois
North Shore University Health System Recruiting
Evanston, Illinois, United States, 60201
Southern Illinois University School of Medicine Not yet recruiting
Springfield, Illinois, United States, 62702
United States, Indiana
American Research, LLC Recruiting
Jeffersonville, Indiana, United States, 47130
Gastroenterology of Southern Indiana Not yet recruiting
New Albany, Indiana, United States, 47150
United States, Kansas
Health Science Research Center Recruiting
Pratt, Kansas, United States, 67124
Professional Research Network of Kansas, LLC Recruiting
Wichita, Kansas, United States, 67205
Via Christi Clinic, PA Recruiting
Wichita, Kansas, United States, 67208
United States, Kentucky
Tri-State Gastroenterology Recruiting
Crestview Hills, Kentucky, United States, 41017
United States, Louisiana
Delta Research Partners, LLC Not yet recruiting
Bastrop, Louisiana, United States, 71220
Clinical Trials of SWLA, LLC Recruiting
Lake Charles, Louisiana, United States, 70601
Clinical Trials of America, Inc. Recruiting
West Monroe, Louisiana, United States, 71291
United States, Maryland
Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research Recruiting
Chevy Chase, Maryland, United States, 20815
Woodholme Gastroenterology Associates, P.A. Recruiting
Glen Burnie, Maryland, United States, 21061
Meritus Center for Clinical Research Not yet recruiting
Hagerstown, Maryland, United States, 21742
United States, Massachusetts
Commonwealth Clinical Studies, PLLC. Recruiting
Brockton, Massachusetts, United States, 02302
United States, Michigan
Clinical Research Institute of Michigan Recruiting
Chesterfield, Michigan, United States, 48047
Aa Mrc, Llc Recruiting
Flint, Michigan, United States, 48504
United States, Missouri
Washington University in St. Louis Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Diabetes and Endocrine Associates, PC Not yet recruiting
Omaha, Nebraska, United States, 68114
Heartland Clinical Research, Inc Recruiting
Omaha, Nebraska, United States, 68134
United States, New Mexico
Lovelace Scientific Resources, Inc. Recruiting
Albuquerque, New Mexico, United States, 87108
United States, New York
Long Island Gastrointestinal Research Group LLP Not yet recruiting
Great Neck, New York, United States, 11023
Winthrop-University Hospital Recruiting
Mineola, New York, United States, 11501
United States, North Carolina
Carolina Digestive Health Associates, PA Recruiting
Davidson, North Carolina, United States, 28036
Kinston Medical Specialists, P.A. Not yet recruiting
Kinston, North Carolina, United States, 28501
Diabetes and Endocrinology Consultants, PC Recruiting
Morehead City, North Carolina, United States, 28557
PMG Research of Wilmington, LLC Recruiting
Wilmington, North Carolina, United States, 28401
Trial Management Associates, LLC Not yet recruiting
Wilmington, North Carolina, United States, 28403
PMG Research of Winston-Salem, LLC Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Dayton Gasteroenterology,Inc. Not yet recruiting
Beavercreek, Ohio, United States, 45440
The MetroHealth System MHS Recruiting
Cleveland, Ohio, United States, 44109-1998
Digestive Disease & Surgery Institute Not yet recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University, Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43203
Aventiv Research, Inc. Recruiting
Columbus, Ohio, United States, 43213
Clinical Inquest Center Ltd. Recruiting
Dayton, Ohio, United States, 45409
United States, Oklahoma
Options Health Research, LLC Recruiting
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Northwest Gastroenterology Clinic, LLC Not yet recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Allegheny Endocrinology Associates Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Guthrie Clinical Research Recruiting
Sayre, Pennsylvania, United States, 18840
Frontier Clinical Research, LLC Recruiting
Scottdale, Pennsylvania, United States, 15683
Preferred Primary Care Physicians Recruiting
Uniontown, Pennsylvania, United States, 15401
United States, Rhode Island
Partners in Clinical Research, LLC Recruiting
Cumberland, Rhode Island, United States, 02864
United States, South Carolina
Clinical Trials of South Carolina Recruiting
Charleston, South Carolina, United States, 29406
United States, South Dakota
Health Concepts Not yet recruiting
Rapid City, South Dakota, United States, 57702
United States, Tennessee
WR-ClinSearch, LLC Recruiting
Chattanooga, Tennessee, United States, 37421
Gastroenterology Centers of the Midsouth Recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
Texas Clinical Research Institute, LLC Recruiting
Arlington, Texas, United States, 76012
ClinRx Research, LLC Recruiting
Carrollton, Texas, United States, 75007
Texas Tech University Health Sciences, Center Division of Gastroenterology Not yet recruiting
El Paso, Texas, United States, 79905
Baylor College of Medicine Medical Center Withdrawn
Houston, Texas, United States, 77030
Biopharma Informatic Inc., Research Center Recruiting
Houston, Texas, United States, 77043
Rodriguez Clinical Trials Recruiting
Houston, Texas, United States, 77083
Memorial Hermann Southeast Medical Plaza 1 Not yet recruiting
Houston, Texas, United States, 77089
Sante Clinical Research Not yet recruiting
Kerrville, Texas, United States, 78028
Digestive Center of South Texas Recruiting
San Antonio, Texas, United States, 78215
Sagact PLLC. Not yet recruiting
San Antonio, Texas, United States, 78229
Texas Digestive Disease Consultantsc Not yet recruiting
Southlake, Texas, United States, 76092
United States, Virginia
Blue Ridge Medical Research Recruiting
Lynchburg, Virginia, United States, 24502
Manassas Clinical Research Centre Recruiting
Manassas, Virginia, United States, 20110
VA Medical Center McGuire VAMC Recruiting
Richmond, Virginia, United States, 23249
United States, Washington
Washington Gastroenterology PLLC Recruiting
Tacoma, Washington, United States, 98405
Argentina
Centro de Investigaciones Medicas Mar del Plata SRL Not yet recruiting
Mar del Plata, Buenos Aires, Argentina, B7600FYK
Consultorios Asociados de Endocrinologia e Investigacion Cl Not yet recruiting
Buenos Aires, Ciudad Autonoma De Buenos Aire, Argentina, C1425AGC
Instituto de Investigaciones Clinicas de Rosario Not yet recruiting
Rosario, Santa Fe, Argentina, 2000
Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli Not yet recruiting
Rosario, Santa Fe, Argentina, S200CFK
Centro Modelo de Cardiologia Not yet recruiting
San Miguel de Tucuman, Tucuman, Argentina, 4000
Hospital Sirio Libanes Not yet recruiting
Buenos Aires, Argentina, C1419AHN
Sanatorio Guemes Not yet recruiting
Caba, Argentina, C1180 AAX
CIPREC Not yet recruiting
Ciudad Autonoma deBuenos Aires, Argentina, 1119
Centro Universitario de Investigacion en Farmacologia Clinic Not yet recruiting
Corrientes, Argentina, W3410AVV
Instituto de Investigaciones Clinicas Cba Not yet recruiting
Córdoba, Argentina, X5000AAW
ILAIM Not yet recruiting
Córdoba, Argentina, X5000BNB
CIAD Moron Not yet recruiting
Moron, Argentina, B1708EPE
Austria
Ordination Not yet recruiting
Sankt Stefan ob Stainz, Styria, Austria, 8511
Medizinische Universitat Innsbruck Not yet recruiting
Innsbruck, Tirol, Austria, A-6020
VIVIT Institute, am LKH Feldkirch Not yet recruiting
Feldkirch, Vorarlberg, Austria, 6807
Klinikum Klagenfurt am Worthersee Not yet recruiting
Klagenfurt, Austria, 9020
Privatklinik Wehrle-Diakonissen Not yet recruiting
Salzburg, Austria, 5020
Oo. Gesundheits- und Spitals-AG/LKH Steyr Not yet recruiting
Steyr, Austria, 4400
Krankenanstalt Rudolfstiftung Wien Withdrawn
Vienna, Austria, 1030
KH Hietzing Withdrawn
Vienna, Austria, 1130
Belgium
Universitair Ziekenhuis Antwerpen, Gastro-Enterologie, Not yet recruiting
Edegem, Antwerp, Belgium, 2650
UZ Brussel Not yet recruiting
Jette, Brussel, Belgium, 1090
AZ Sint Lucas Brugge Not yet recruiting
Brugge, West-Vlaanderen, Belgium, 8310
Hopitaux Iris Sud - Joseph Bracops Withdrawn
Brussels, Belgium, 1070
Brazil
Hospital Universitario Walter Cantidio Not yet recruiting
Fortaleza, Ceara, Brazil, 60430-372
Centro de Pesquisa Clinica do Brasil Not yet recruiting
Brasilia, Distrito Federal, Brazil, 71625175
CETI - Centro de Estudos em Terapias Inovadoras Not yet recruiting
Curitiba, Paraná, Brazil, 80030-110
Hospital Universitario Joao de Barros Barreto Not yet recruiting
Belem, Para, Brazil, 66073-000
Hospital Sao Vicente de Paulo Not yet recruiting
Passo Fundo- RS, Rio Grande Do Sul, Brazil, 99010-080
Hospital de Clinicas de Porto Alegre/ Nucleo de Pesquisa Clinica do Rio Grande do Sul Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Hospital Sao Lucas da PUC-RS Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
NOOVA Not yet recruiting
Florianópolis, Santa Catarina, Brazil, 88015-230
Instituto Catarinense de Endocrinologia e Diabetes (ICED) Not yet recruiting
Joinville, Santa Catarina, Brazil, 89201-260
Instituto de Pesquisa Clinica em Campinas Not yet recruiting
Campinas, Sao Paulo, Brazil, 13060-080
Universidade de Sao Paulo (USP) - Hospital das Clinicas da F Not yet recruiting
Cerqueira Cesar - Sao Paulo, Sao Paulo, Brazil, Cep 05403-000
Scentryphar Pesquisa Clinica Ltda Not yet recruiting
Campinas, SÃo Paulo, Brazil, 13020-431
Instituto de Estudos E Persquisas Clinica Do Ceara IEP/CE - Oncology Not yet recruiting
Fortaleza, Brazil, 60160-230
CPQuali Pesquisa Clinica Ltda Not yet recruiting
Sao Paulo, Brazil, 01228-000
Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda Not yet recruiting
SÃo Paulo, Brazil, 01223-001
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 2T9
Alberta Diabetes Institute Recruiting
Edmonton, Alberta, Canada, T6G 2E1
The Bailey Clinic Recruiting
Red Deer, Alberta, Canada, T4N 6V7
Canada, British Columbia
Gordon and Leslie Diamond Health Care Centre Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Newfoundland and Labrador
Eastern Health Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Medical Clinic Recruiting
Bridgewater, Nova Scotia, Canada, B4V 2V6
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 7W9
Sunnybrook Health Science Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Toronto Western Hospital, University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Toronto Liver Centre Recruiting
Toronto, Ontario, Canada, M6H 3M1
Dr. Anil K. Gupta Medicine Professional Corporation Active, not recruiting
Toronto, Ontario, Canada, M9V 4B4
Toronto Digestive Disease Associates, Inc. Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
CISSS de la Monteregie-Centre Not yet recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Recherche GCP Research Recruiting
Montreal, Quebec, Canada, H1M 1B1
Centre Hospitalier de l'Universite de Montreal - CHUM Not yet recruiting
Montreal, Quebec, Canada, H2X 0A9
Colombia
IPS Rodrigo Botero SAS Not yet recruiting
Medellin, Antioquia, Colombia, 050030
Centro Cardiovascular Colombiano Clínica Santa María Not yet recruiting
Medellin, Antioquia, Colombia, 050034
Centro Cardiovascular y de Diabetes Not yet recruiting
Barranquilla, Atlantico, Colombia, 080020
Fundacion Bios Not yet recruiting
Barranquilla, Atlantico, Colombia, 080020
Healthy Medical Center Not yet recruiting
Zipaquira, Cundinamarca, Colombia, 250252
Medplus Mp Not yet recruiting
Bogota, Distrito Capital De Bogotá, Colombia, 110221
Endocare Ltda. Not yet recruiting
Bogota, Distrito Capital De Bogotá, Colombia, 111111
Asociación Colombiana de Diabetes Not yet recruiting
Teusaquillo, Distrito Capital De Bogotá, Colombia, 111311
Fundacion Centro de Investigaciones Clinicas CARDIOMET Not yet recruiting
Pereira, Risaralda, Colombia, 660002
IPS Centro Medico Julian Coronel S.A Not yet recruiting
Cali, Valle Del Cauca, Colombia, 760035
Centro Medico Imbanaco de Cali S.A. Not yet recruiting
Cali, Valle Del Cauca, Colombia, 760042
Clinica Meta Not yet recruiting
Meta, Colombia, 500001
Denmark
Gentofte Hospital/ Steno Diabetes Center Copenhagen Not yet recruiting
Hellerup, Copenhagen, Denmark, 2900
Gastroenheden, Hvidovre hospital Not yet recruiting
Hvidovre, København, Denmark, 2605
Endocrinology, Aalborg University Hospital Not yet recruiting
Aalborg, Denmark, DK-9000
MEA KFA Withdrawn
Aarhus, Denmark, 8000
Nordsjaellands Hospital Withdrawn
Hilleroed, Denmark, 3400
Germany
Klinische Forschung Karlsruhe GmbH Not yet recruiting
Karlsruhe, Baden-SWürttemberg, Germany, 76199
Praxis Dr. Etzrodt-Walter und Kollegen Not yet recruiting
Ulm, Baden-württemberg, Germany, 89073
Klinische Forschung Schwerin GmbH Not yet recruiting
Schwerin, Mecklenburg Vorpommern, Germany, 19055
Studienzentrum Schwittay Not yet recruiting
Böhlen, Saxony, Germany, 4564
Klinische Forschung Dresden GmbH Not yet recruiting
Dresden, Saxony, Germany, 1309
Diabetologische Schwerpunktpraxis Not yet recruiting
Bad Berleburg, Germany, 57319
Clinical Research Unit Not yet recruiting
Giessen, Germany, 32392
Klinische Forschung Hamburg GmbH Not yet recruiting
Hamburg, Germany, 20253
Clinical Research Hamburg Not yet recruiting
Hamburg, Germany, 22143
Israelitisches Krankenhaus Not yet recruiting
Hamburg, Germany, 22297
Klinische Forschung Hannover-Mitte GmbH Not yet recruiting
Hannover, Germany, 30159
Klinikum Region Hannover/KRH Siloah Not yet recruiting
Hannover, Germany, 30459
Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet Not yet recruiting
Eger, Heves, Hungary, H-3300
Hetenyi Geza Hospital Not yet recruiting
Szolnok, Jász-Nagykun-Szolnok, Hungary, H-5004
Zala Megyei Szent Rafael Korhaz Recruiting
Zalaegerszeg, Zala, Hungary, H-8900
Semmelweis University Withdrawn
Budapest, Hungary, H-1088
Strázsahegy Gyógyszertár Medicina Not yet recruiting
Budapest, Hungary, H1171
Coromed SMO Withdrawn
Pecs, Hungary, 7623
Szegedi Tudomanyegyetem Not yet recruiting
Szeged, Hungary, H-6720
Latvia
Polana-D, LLC Recruiting
Daugavpils, Latvia, LV5401
Kraslava Hospital Not yet recruiting
Kraslava, Latvia, 5601
Pauls Stradins Clinical University Hospital, Endokrinologijas nodala Recruiting
Riga, Latvia, 1002
Digestive Diseases Centre GASTRO Not yet recruiting
Riga, Latvia, 1006
Mexico
Clinicos Asociados BOCM SC Not yet recruiting
Benito Juarez, Distrito Federal, Mexico, 03300
Centro de Investigacion Morales Vargas - CIMOVA Not yet recruiting
León, Guanajuato, Mexico, 37000
CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición) Not yet recruiting
Durango, Guillermina, Mexico, 34270
Centro de Diabetes de Pachuca Not yet recruiting
Pachuca, Hidalgo, Mexico, 42090
Consultorio Medico Not yet recruiting
Guadalajara, Jalisco, Mexico, 44210
Unidad de Investigación Clínica en Medicina S.C. Not yet recruiting
Guadalajara, Jalisco, Mexico, 44670
Unidad de Investigacion Clinica Cardiometabolica de Occidente Not yet recruiting
Guadalajra, Jalisco, Mexico, 44150
Medical and Nutritional Trials Not yet recruiting
Distrito Federal, Mexico DF, Mexico, 06700
Clinica Omega (CAIFRC OMEGA S.C.) Not yet recruiting
Mexico, Mexico DF, Mexico, 14000
Instituto de Diabetes Obesidad y Nutricion SC Not yet recruiting
Cuautla, Morelos, Mexico, 62746
Accelerium Clinical Research Not yet recruiting
Monterrey, Nuevo León, Mexico, 64000
Investigacion Medica Sonora, S.C. Not yet recruiting
Hermosillo, Sonora, Mexico, 83280
Clínica de Mérida Not yet recruiting
Mérida, Yucatán, Mexico, 97070
Practice Dr Gerardo Gonzalez Not yet recruiting
Acapulco, Mexico, 39350
Hospital Cardiologica Aguascalientes Not yet recruiting
Aguascalientes, Mexico, 20230
Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV Not yet recruiting
Aguscalientes, Mexico, 20230
Dioderm Instituto de Investigacion Not yet recruiting
Durango, Mexico, 34060
Centro Medico Christus Muguerza Sur Not yet recruiting
Nuevo Leon, Mexico, 313-315
Instituto Nacional de Ciencias Medicas y Nutricion Not yet recruiting
Tlalpan C.P., Mexico, 14080
Centro Especializado en Investigacion Clinica S.C. Not yet recruiting
Veracruz, Mexico, 34230
Sociedad de Metabolismo y Corazon, S.C. Not yet recruiting
Veracruz, Mexico, C.P. 91900
Romania
ClinTrial Medical Center, Pulmonology Department Not yet recruiting
Dobrosloveni, Oltenia, Romania, 237143
Sana Medical Center Not yet recruiting
Bucharest, Romania, 011025
National Institute of Endocrinology Not yet recruiting
Bucharest, Romania, 11863
AMES Research Center SRL Not yet recruiting
Calarasi, Romania, 910103
Polisano-Clinic Withdrawn
Sibiu, Romania, 550253
Russian Federation
Saint-Petersburg City Pokrovskaya Hospital Not yet recruiting
St-Petersburg, Leningrad Region, Russian Federation, 199106
GUZ Â"Saratov City Clinical Hospital 9 Not yet recruiting
Saratov, Saratov Region, Russian Federation, 410030
Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko Not yet recruiting
Nizhny Novgorod, Volga, Russian Federation, 603126
Kazan State Medical University Not yet recruiting
Kazan, Russian Federation, 420012
FSBI National medical endocrinology research centre Not yet recruiting
Moscow, Russian Federation, 117036
Moscow Regional Research Clinical Institute named by MF Vladimirski Not yet recruiting
Moscow, Russian Federation, 129110
Scientific Institute of Clinical and Experimental Lymphology Not yet recruiting
Novosibirsk, Russian Federation, 630117
Rostov on Don Not yet recruiting
Rostov on Don, Russian Federation, 344006
Rostov State Medical University Not yet recruiting
Rostov-on-Don, Russian Federation, 344022
Millitary-medical Academy, department of hospital therapy Not yet recruiting
Saint-Petersburg, Russian Federation, 191015
North-Western State Medical University named after I. I. Mechnikov Not yet recruiting
Saint-Petersburg, Russian Federation, 191015
Saratov City Clinical Hospital 12 Not yet recruiting
Saratov, Russian Federation, 410039
South Africa
FARMOVS Not yet recruiting
Bloemfontein, Free State, South Africa, 9301
Wits Clinical Research Not yet recruiting
Johannesburg, Gauteng, South Africa, 2193
Synexus Stanza Clincal Reaserch Centre Not yet recruiting
Pretoria, Gauteng, South Africa, 0122
Watermeyer Clinical Research Site Not yet recruiting
Silverton, Gauteng, South Africa, 184
Soweto CTC Not yet recruiting
Soweto, Gauteng, South Africa, 1818
Endocare Withdrawn
Paarl, Western Cape, South Africa, 7646
Moriana Clinical Research Withdrawn
Brandfort, South Africa, 9400
Synexus Helderberg Clinical Research Centre Not yet recruiting
Cape Town, South Africa, 07130
TREAD Research Not yet recruiting
Cape Town, South Africa, 7500
Ukraine
SU" Clinic of medical academy" of SI "Dnepropetrovsk medical cacadamy of MoH of Ukraine" Not yet recruiting
Dnipro, Ukraine, 49038
United Kingdom
Queens Medical Centre Not yet recruiting
Nottingham, East Midland, United Kingdom, NG7 2UH
MAC Clinical Research Manchester Recruiting
Manchester, Greater Manchester, United Kingdom, M13 9NQ
Royal Oldham Hospital Not yet recruiting
Oldham, Lancashire, United Kingdom, OL1 2JH
St George's Hospital Withdrawn
Tooting, London, United Kingdom, SW17 0QT
MAC Research, Exchange House Recruiting
Cannock, Staffordshire, United Kingdom, WS11 0BH
University Hospitals of North Midlands Not yet recruiting
Stoke on Trent, Staffordshire, United Kingdom, ST6 8DG
Royal Wolverhampton NHS Trust Not yet recruiting
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
MAC Clinical Research, Monarch House Recruiting
Leeds, West Yorkshire, United Kingdom, LS10 1DU
MAC Research Recruiting
Barnsley, United Kingdom, S75 3DL
MAC Clinical Research Recruiting
Blackpool, United Kingdom, FY2 0JH
Mid Essex Hospital Services NHS Trust Broomfield Hospital Not yet recruiting
Chelmsford, United Kingdom, CM1 7ET
Western General Hospital Not yet recruiting
Edinburgh, United Kingdom, EH4 2XU
MAC Clinical Research Recruiting
Liverpool, United Kingdom, L34 1BH
Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital Not yet recruiting
London, United Kingdom, E1 2AJ
University College London Hospita Not yet recruiting
London, United Kingdom, NW1 2BU
University Hospital of South Manchester Withdrawn
Manchester, United Kingdom, M23 9LT
The Newcastle upon Tyne Hospitals NHS Foundation Trust Not yet recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
MAC Clinical Research, GAC House Not yet recruiting
Stockton-on-Tees, United Kingdom, TS17 6EW
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     History of Changes
Other Study ID Numbers: RLM-MD-02
2017-002177-20 ( EudraCT Number )
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
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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Diabetes Mellitus
Gastroparesis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms