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

A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus; Gastroparesis
• Intervention / Treatment: Drug: Placebo; Drug: Relamorelin

• Study Type: Interventional
• Enrollment (Actual): 311
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos Aires, Argentina, 1119
    • CIPREC
  • Corrientes, Argentina, W3410AVV
    • Centro Universitario de Investigación en Farmacologia Clínic
  • Córdoba, Argentina, X5000BNB
    • CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian
  • Buenos Aires Province
    • C.a.b.a., Buenos Aires Province, Argentina, C1425AGC
      • Maffei Centro Medico-Investigacion Clinica Aplicada
    • Caba, Buenos Aires Province, Argentina, C1419AHN
      • Hospital Sírio Libanês
    • Mar del Plata, Buenos Aires Province, Argentina, B7600FYK
      • Centro de Investigaciones Medicas Mar del Plata SRL
  • Cordoba
    • Córdoba, Cordoba, Argentina, X5000AAW
      • Instituto Privado de Investigaciones Clinicas de Cordoba
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Instituto de Investigaciones Clinicas de Rosario
    • Rosario, Santa Fe, Argentina, S200CFK
      • Instituto de Hematologia y Medicina Clinica Dr. RUben Davoli
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Clinica Mayo - Infectious DiseasesClínica Mayo de Urgencias
• Austria
  • Salzburg, Austria, 5020
    • Privatklinik Wehrle-Diakonissen
  • Steyr, Austria, 4400
    • Oö. Gesundheits- und Spitals-AG/LKH Steyr
  • Steiermark
    • Sankt Stefan, Steiermark, Austria, 8511
      • Ordination
  • Vorarlberg
    • Feldkirch, Vorarlberg, Austria, 6807
      • VIVIT Institute, am LKH Feldkirch
• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
  • Antwerpen
    • Brugge, Antwerpen, Belgium, 2650
      • AZ Sint Lucas Brugge
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • UZ Brussel
• Brazil
  • Fortaleza, Brazil, 60160-230
    • Instituto de Estudos E Persquisas Clinicas do Ceará - IEP/CE - Oncology
  • SÃo Paulo, Brazil, 01223-001
    • Instituto de Pesquisa Clínica e Medicina Avançada Ltda
  • Ceara
    • Fortaleza, Ceara, Brazil, 60430-372
      • Hospital Universitario Walter Cantidio
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 71625175
      • Centro de Pesquisa Clinica do Brasil
  • Para
    • Belem, Para, Brazil, 66073-000
      • Hospital Universitário João de Barros Barreto
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
      • Nucleo de Pesquisa Clinica do Rio Grande do Sul
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89201-260
      • Instituto Catarinense de Endocrinologia e Diabetes (ICED)
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil, 13020-431
      • Scentryphar Pesquisa Clinica Ltda
    • Campinas, Sao Paulo, Brazil, 13060-080
      • Instituto de Pesquisa Clinica em Campinas
    • Santa Cecília, Sao Paulo, Brazil, 01228-000
      • CPQuali Pesquisa Clinica Ltda
• Canada
  • Red Deer, Canada, T4N 6V7
    • Central Alberta Research Centre
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 2E1
      • Alberta Diabetes Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Gordon and Leslie Diamond Health Care Centre
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Eastern Health
  • Nova Scotia
    • Bridgewater, Nova Scotia, Canada, B4V 2V6
      • South Shore Medical Arts
  • Ontario
    • Ottawa, Ontario, Canada, K1H 7W9
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M6H 3M1
      • Toronto Liver Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Science Centre
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital, University Health Network
    • Vaughan, Ontario, Canada, L4L 4YZ
      • Toronto Digestive Disease Associates
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • CISSS de la Monteregie-Centre
    • Montreal, Quebec, Canada, H1M 1B1
      • Recherche GCP Research
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Université de Montréal - CHUM
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050034
      • Centro Cardiovascular Colombiano Clínica Santa María
    • Medellin, Antioquia, Colombia, 50030
      • Rodrigo Botero S.A.S.
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080020
      • Centro Cardiovascular y de Diabetes
    • Barranquilla, Atlantico, Colombia, 080020
      • Fundacion BIOS
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia, 111311
      • Asociación Colombiana de Diabetes
    • Zipaquira, Cundinamarca, Colombia, 250252
      • Healthy Medical Center
  • Distrito Capital De Bogotá
    • Bogota, Distrito Capital De Bogotá, Colombia, 110221
      • Medplus Mp
    • Bogota, Distrito Capital De Bogotá, Colombia, 111111
      • Endocare Ltda.
  • Risaralda
    • Pereira, Risaralda, Colombia, 660002
      • Fundacion Centro de Investigaciones Clinicas CARDIOMET
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia, 760035
      • IPS Centro Medico Julian Coronel S.A
    • Cali, Valle Del Cauca, Colombia, 760042
      • Centro Medico Imbanaco de Cali S.A.
• Denmark
  • Aalborg, Denmark, DK-9000
    • Endocrinology, Aalborg University Hospital
  • Hellerup, Denmark, 2900
    • Center for Clinical Metabolic Research
  • Copenhagen
    • Hvidovre, Copenhagen, Denmark, 2605
      • Gastroenheden, Hvidovre Hospital
• Germany
  • Giessen, Germany, 32392
    • Clinical Research Unit
  • Hamburg, Germany, 22143
    • Clinical Research Hamburg
  • Hamburg, Germany, 22297
    • Israelitisches Krankenhaus
  • Hannover, Germany, 30459
    • KRH Klinikum Siloah
  • Baden-SWürttemberg
    • Karlsruhe, Baden-SWürttemberg, Germany, 76199
      • Klinische Forschung Karlsruhe GmbH
  • Saxony
    • Böhlen, Saxony, Germany, 4564
      • Studienzentrum Schwittay
    • Dresden, Saxony, Germany, 1309
      • Klinische Forschung Dresden Gmbh
• Hungary
  • Budapest, Hungary, 1036
    • Synexus Budapest DRS
  • Budapest, Hungary, H1171
    • Strázsahegy Gyógyszertár Medicina
  • Debrecen, Hungary, 4025
    • SYNEXUS Magyarorszag Kft Debrecen A.S.
  • Gyula, Hungary, 5700
    • Synexus Magyarorszag Kft. Gyula DRS
  • Szeged, Hungary, H-6720
    • Szegedi Tudomanyegyetem
  • Zalaegerszeg, Hungary, 8900
    • Synexus Magyarorszag Kft
  • Heves
    • Eger, Heves, Hungary, H-3300
      • Markhot Ferenc Oktatokorhaz és Rendelointezet
    • Hatvan, Heves, Hungary, 3000
      • BKS Research Kft Synexus AS
  • Jász-Nagykun-Szolnok
    • Szolnok, Jász-Nagykun-Szolnok, Hungary, H-5004
      • Hetenyi Geza Hospital
  • Zala
    • Zalaegerszeg, Zala, Hungary, H-8900
      • Zala Megyei Szent Rafael Korhaz
• Latvia
  • Daugavpils, Latvia, 5401
    • Polana-D
  • Kraslava, Latvia, 5601
    • Kraslava Hospital
  • Riga, Latvia, 1002
    • Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
  • Riga, Latvia, 1006
    • Digestive Diseases Centre GASTRO
• Mexico
  • Aguascalientes, Mexico, 20230
    • Hospital Cardiologica Aguascalientes
  • Aguascalientes, Mexico, 20230
    • Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
  • Durango, Mexico, 34060
    • Dioderm Instituto de Investigacion
  • Veracruz, Mexico, C.P. 91900
    • Sociedad de Metabolismo y Corazon, S.C.
  • Cdmx
    • Cuauhtemoc, Cdmx, Mexico, 06700
      • Medical and Nutritional Trials
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 11650
      • Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology
    • Mexico, Distrito Federal, Mexico, 14000
      • Centro de Atención e Investigación en Factores de Riesgo Car
    • Portales, Distrito Federal, Mexico, 03300
      • Clinicos Asociados BOCM SC
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44150
      • Unidad de Investigacion Clinica Cardiometabolica de Occidente
    • Guadalajara, Jalisco, Mexico, C.P. 44210
      • Consultorio Medico
    • Guadalajara, Jalisco, Mexico, C.P. 44670
      • Unidad de Investigacion Clinica en Medicina S.C.
  • Yucatan
    • Mérida, Yucatan, Mexico, 97070
      • Centro de Desarrollo Biomédico S.C.P.
• Russian Federation
  • Kazan, Russian Federation, 420012
    • Kazan State Medical University
  • Moscow, Russian Federation, 117036
    • FSBI National medical endocrinology research centre
  • Moscow, Russian Federation, 129110
    • Moscow Regional Research Clinical Institute named by MF Vladimirski
  • Rostov on Don, Russian Federation, 344019
    • Rostov on Don
  • Rostov-on-Don, Russian Federation, 344022
    • Rostov State Medical University
  • Saint-Petersburg, Russian Federation, 191015
    • North-Western State Medical University named after I. I. Mechnikov
  • Saratov, Russian Federation, 410039
    • Saratov City Clinical Hospital 12
  • Leningrad Region
    • St-Petersburg, Leningrad Region, Russian Federation, 199106
      • Saint-Petersburg City Pokrovskaya Hospital
  • Novosibirsk Oblast
    • Novosibirsk, Novosibirsk Oblast, Russian Federation, 630117
      • Scientific Institute of Clinical and Experimental Lymphology
  • Saratov Region
    • Saratov, Saratov Region, Russian Federation, 410030
      • GUZ Saratov City Clinical Hospital 9
  • Volga
    • Nizhny Novgorod, Volga, Russian Federation, 603126
      • Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko
• South Africa
  • Cape Town, South Africa, 7500
    • TREAD Research
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • FARMOVS
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Wits Clinical Research
    • Pretoria, Gauteng, South Africa, 0122
      • Synexus Stanza Clinical Research Centre
    • Silverton, Gauteng, South Africa, 184
      • Watermeyer Clinical Research Site
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7130
      • Synexus Helderberg Clinical Research Centre
• United Kingdom
  • Barnsley, United Kingdom, S75 3DL
    • MAC Research
  • Blackpool, United Kingdom, FY2 0JH
    • MAC Clinical Research
  • Cardiff, United Kingdom, CF15 9SS
    • Synexus Wales Clinical Research Centre
  • Chelmsford, United Kingdom, CM1 7ET
    • Mid Essex Hospital Services NHS Trust Broomfield Hospital
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • Liverpool, United Kingdom, L34 1BH
    • MAC Clinical Research
  • Liverpool, United Kingdom, L22 0LG
    • Synexus Merseyside Dedicated Research Centre
  • London, United Kingdom, E1 2AJ
    • Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital
  • Manchester, United Kingdom, M13 9NQ
    • MAC Clinical Research, GAC House
  • Manchester, United Kingdom, M15 6SX
    • Synexus Manchester Clinical Research Centre
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Royal Victoria Infirmary: Clinical Research Facility
  • Nottingham, United Kingdom, NG7 2UH
    • Biomedical Research Centre
  • Stockton-on-Tees, United Kingdom, TS19 8PE
    • Synexus Hexham Dedicated Research Centre
  • Stockton-on-Tees, United Kingdom, TS19 8PE
    • Synexus North Tees Clinical Research Centre
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9NQ
      • MAC Clinical Research Manchester
  • Lancashire
    • Chorley, Lancashire, United Kingdom, PR7 7NA
      • Synexus Lancashire Dedicated Research Centre
    • Oldham, Lancashire, United Kingdom, OL1 2JH
      • Royal Oldham Hospital
  • Staffordshire
    • Cannock, Staffordshire, United Kingdom, WS11 0BH
      • MAC Research, Exchange House
    • Stoke on Trent, Staffordshire, United Kingdom, ST6 8DG
      • University Hospitals of North Midlands
  • West Midlands
    • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
      • Royal Wolverhampton Nhs Trust
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS10 1DU
      • MAC Clinical Research, Monarch House
• United States
  • Alabama
    • Athens, Alabama, United States, 35611
      • North Alabama Research Center, LLC
    • Birmingham, Alabama, United States, 35211
      • Synexus Clinical Research US - Simon Williamson Clinic
    • Foley, Alabama, United States, 36535
      • G & L Research, LLC
    • Mobile, Alabama, United States, 36608
      • Alabama Medical Group, PC
  • Arizona
    • Tucson, Arizona, United States, 85741
      • Synexus Clinical Research US, Inc.
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Arkansas
    • Searcy, Arkansas, United States, 72143
      • Unity Health - Searcy Medical Center
  • California
    • Chula Vista, California, United States, 91910
      • GW Research Inc.
    • Encinitas, California, United States, 92024
      • Diagnamics Inc.
    • Fresno, California, United States, 93720
      • Fresno Clinical Research Center
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute, Inc.
    • Long Beach, California, United States, 90822
      • Tibor Rubin VA Medical Center
    • Los Angeles, California, United States, 90026
      • Angel City Research Inc.
    • Mission Hills, California, United States, 91345
      • FACEY Medical Foundation
    • Murrieta, California, United States, 92563
      • United Medical Doctors
    • Palo Alto, California, United States, 94304
      • Stanford Hospital, Digestive Health Clinic
    • Poway, California, United States, 92064
      • TriWest Research Associates
    • San Diego, California, United States, 92108
      • Optimal Research California
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
    • Whittier, California, United States, 90603
      • New Hope Research Development
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
  • Connecticut
    • Bridgeport, Connecticut, United States, 06824
      • Gastroenterology Associates of Fairfield County, P.C.
  • Florida
    • Aventura, Florida, United States, 33180
      • Visionary Investigators Network
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • Cooper City, Florida, United States, 33024
      • ALL Medical Research LLC
    • Hialeah, Florida, United States, 33016
      • Palmetto Research, LLC
    • Homestead, Florida, United States, 33030
      • Vida Clinical Trials
    • Miami, Florida, United States, 33157
      • Sanchez Clinical Research, Inc.
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Of Naples
    • Pinellas Park, Florida, United States, 33781
      • Synexus
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida - Weston
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Blue Ridge, Georgia, United States, 30513
      • River Birch Research Alliance, LLC
    • Buford, Georgia, United States, 30519
      • Gwinnett Research Institute, LLC
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta LLC
    • Suwanee, Georgia, United States, 30024
      • Clinical Research Consultants of Atlanta
  • Idaho
    • Idaho Falls, Idaho, United States, 83404-7596
      • Rocky Mountain Diabetes and Osteoporosis Center, PA
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
    • Chicago, Illinois, United States, 60602
      • Synexus Clinical Research US, Inc.
    • Evanston, Illinois, United States, 60201
      • North Shore University Health System
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • American Research, LLC
    • New Albany, Indiana, United States, 47150
      • Gastroenterology of Southern Indiana
  • Kansas
    • Pratt, Kansas, United States, 67124
      • Health Science Research Center
    • Shawnee Mission, Kansas, United States, 67214
      • Westglen Gastrointestinal Consultants
    • Topeka, Kansas, United States, 66606
      • Kansas Medical Clinic
    • Wichita, Kansas, United States, 67205
      • Professional Research Network of Kansas, LLC
    • Wichita, Kansas, United States, 67208
      • Via Christi Clinic, PA
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Tri-State Gastroenterology
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • WK Physicians Network
    • Crowley, Louisiana, United States, 70526
      • Avant Research Associates LLC
    • Lake Charles, Louisiana, United States, 70601
      • Clinical Trials of SWLA, LLC
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
    • West Monroe, Louisiana, United States, 71291
      • Clinical Trials of America, Inc.
  • Maryland
    • Bowie, Maryland, United States, 20716
      • Trialspark - Sood
    • Camp Springs, Maryland, United States, 20746
      • Capital Diabetes and Endocrine Associates
    • Chevy Chase, Maryland, United States, 20815
      • Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
    • Glen Burnie, Maryland, United States, 21061
      • Woodholme Gastroenterology Associates, P.A.
    • Hagerstown, Maryland, United States, 21742
      • Meritus Center for Clinical Research
    • Rockville, Maryland, United States, 20854
      • Meridian Clinical Research, LLC
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Commonwealth Clinical Studies, PLLC.
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan
    • Flint, Michigan, United States, 48504
      • Aa Mrc Llc
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis
    • Saint Louis, Missouri, United States, 63141
      • Synexus Clinical Research US, Inc
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Heartland Clinical Research, Inc
  • New Jersey
    • Elizabeth, New Jersey, United States, 07201
      • USMA Clinical Research, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Lovelace Scientific Resources, Inc.
  • New York
    • Jamaica, New York, United States, 11432
      • Synexus Clinical Research US, Inc.
    • Mineola, New York, United States, 11501
      • Winthrop-University Hospital
  • North Carolina
    • Davidson, North Carolina, United States, 28036
      • Carolina Digestive Health Associates, PA
    • Kinston, North Carolina, United States, 28501
      • Kinston Medical Specialists, P.A.
    • Morehead City, North Carolina, United States, 28557
      • Diabetes and Endocrinology Consultants, PC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem, LLC
  • Ohio
    • Akron, Ohio, United States, 44311
      • Synexus Clinical Research US, Inc.
    • Canton, Ohio, United States, 44718
      • Diabetes & Endocrinology Associates of Stark County, Inc.
    • Cincinnati, Ohio, United States, 45236
      • Synexus Clinical Research US - Cincinnati
    • Cincinnati, Ohio, United States, 45249
      • Synexus Clinical Research US, Inc
    • Cleveland, Ohio, United States, 44109-1998
      • The MetroHealth System MHS
    • Cleveland, Ohio, United States, 44195
      • Digestive Disease & Surgery Institute
    • Columbus, Ohio, United States, 43213
      • Aventiv Research, Inc.
    • Columbus, Ohio, United States, 43203
      • The Ohio State University, Wexner Medical Center
    • Dayton, Ohio, United States, 45424
      • Hometown Urgent Care and Research
    • Dayton, Ohio, United States, 45409
      • CIC America Clinical Inquest Center Ltd.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73111
      • Centennial Health-Synexus
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research, LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Endocrinology Associates
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Clinical Research
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research, LLC
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Care Access Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Synexus Clinical Research US, Inc.
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch
    • Germantown, Tennessee, United States, 38138
      • Gastro One
    • Johnson City, Tennessee, United States, 37604
      • East Tennessee Research Institute
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Clinical Research Institute, LLC
    • Carrollton, Texas, United States, 75007
      • ClinRx Research, LLC
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine Medical Center
    • Houston, Texas, United States, 77079
      • Houston Endoscopy and Research Center, Inc.
    • Houston, Texas, United States, 77043
      • Biopharma Informatic Inc., Research Center
    • Houston, Texas, United States, 77083
      • Rodriguez Clinical Trials
    • Kerrville, Texas, United States, 78028
      • Sante Clinical Research
    • San Antonio, Texas, United States, 78229
      • Synexus Clinical Research US, Inc.
    • San Antonio, Texas, United States, 78215
      • Pinnacle Clinical Research
    • San Antonio, Texas, United States, 78233
      • Digestive & Liver Disease Center of San Antonio, PLLC
    • Sugar Land, Texas, United States, 77479
      • Dwayne O. Williams MD
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Blue Ridge Medical Research
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Centre
    • Richmond, Virginia, United States, 23249
      • VA Medical Center McGuire VAMC
  • Washington
    • Tacoma, Washington, United States, 98405
      • Washington Gastroenterology PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Drug: Placebo; Placebo injected subcutaneously twice daily.
Experimental: 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.	Drug: Relamorelin; Relamorelin 10 μg injected twice daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.	Week 6 to Week 12
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)	Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0= no or not at all uncomfortable to 10= worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period.	Baseline (Day-14 to Day-1) to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)	An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.	Up to approximately 16 weeks
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results	Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.	Up to 12 weeks
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results	A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.	Up to 12 weeks
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit	A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.	Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	A Nausea Responder was defined as a participant with improvement (decrease) 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 was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0= no nausea to 10= worst possible nausea.	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	An Abdominal Pain Responder was defined as a participant with an improvement (decrease) 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 was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0= no abdominal pain to 10= the worst possible abdominal pain and was recorded in an e-diary.	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	A Bloating Responder was defined as a participant with an improvement (decrease) 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 was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0= no bloating and 10= the worst possible bloating and was recorded in the e-diary.	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) 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 was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0= no feeling of fullness until finishing a meal (best) to 10= feeling full after only a few bites (worst).	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Number of Participants With Clinically Meaningful Trends for Vital Signs	Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.	Up to 12 weeks
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)		Baseline (Day 1) up to 12 weeks

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Wieslaw (Wes) Bochenek, MD, PhD, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2018
• Primary Completion (Actual): July 16, 2020
• Study Completion (Actual): July 16, 2020

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: RLM-MD-02; 2017-002177-20 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No