A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

November 19, 2021 updated by: Allergan

A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, X5000BNB
        • CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian
      • Corrientes, Argentina, W3410AVV
        • Centro Universitario de Investigación en Farmacologia Clínic
      • Córdoba, Argentina, X5000AAW
        • Instituto Privado de Investigaciones Clinicas de Cordoba
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, B7600FYK
        • Centro de Investigaciones Medicas Mar del Plata SRL
    • Buenos Aires Province
      • Buenos Aires, Buenos Aires Province, Argentina, C1425AGC
        • Consultorios Asociados de Endocrinologia e Investigación Cl
      • Caba, Buenos Aires Province, Argentina, C1419AHN
        • Hospital Sírio Libanês
    • Ciudad Autonoma deBuenos Aires
      • Buenos Aires, Ciudad Autonoma deBuenos Aires, Argentina, 1119
        • CIPREC
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000BIE
        • Instituto de Investigaciones Clinicas de Rosario
      • Rosario, Santa Fe, Argentina, S200CFK
        • Instituto Medico Catamarca-I.ME.C
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Nepean Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Austria
      • Salzburg, Austria, 5020
        • Privatklinik wehlre-Diakonissen
      • Steyr, Austria, 4400
        • Oö. Gesundheits- und Spitals-AG/LKH Steyr
    • Steiermark
      • Osterreicher, 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,
    • Brussel
      • Jette, Brussel, Belgium, 1090
        • UZ Brussel
    • West-Vlaanderen
      • Brugge, West-Vlaanderen, Belgium, 8310
        • AZ Sint Lucas Brugge
  • Brazil
      • Fortaleza, Brazil, 60160-230
        • Instituto de Estudos e Pesquisas Clinicas do Ceará IEP/CE - Oncology
      • Sao Paulo, Brazil, 01223-001
        • IPEC-Instituto de Pesquisa Clinica
      • Sao Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clinica Ltda
    • CE
      • Fortaleza, CE, Brazil, 60430-270
        • Hospital Universitario Walter Cantidio
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 71625175
        • Centro de Pesquisa Clinica do Brasil
    • PA
      • Belem, PA, Brazil, 66073-005
        • Hospital Universitário João de Barros Barreto - UFPA
    • 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
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • UMHAT - Kaspela- EOOD
      • Sofia, Bulgaria, 1303
        • Medical Center Asklepion - Humane Medicine Research EOOD
      • Sofia, Bulgaria, 1431
        • Alexandrovska University Hospital
    • Ruse
      • Byala, Ruse, Bulgaria, 7100
        • MHAT Yuliya Vrevska Byala
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University of Calgary
      • Red Deer, Alberta, Canada, T4N 6V7
        • Central Alberta Research Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Patient research centre
    • Nova Scotia
      • Bridgewater, Nova Scotia, Canada, B4V 3N2
        • South Shore Medical Arts
    • Ontario
      • Ottawa, Ontario, Canada, K1H 7W9
        • The Ottawa Hospital
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates, Inc.
    • Quebec
      • Montreal, Quebec, Canada, H1M 1B1
        • Recherche GCP Research
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050034
        • Centro Cardiovascular Colombiano Clínica Santa María
      • Medellín, Antioquia, Colombia, 050030
        • Rodrigo Botero S.A.S.
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Centro Cardiovascular y de Diabetes
      • Barranquilla, Atlantico, Colombia, 080020
        • Fundación del Caribe para la InvestigacionBiomédica-Fundación BIOS
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 111311
        • Asociación Colombiana de Diabetes
      • Zipaquira, Cundinamarca, Colombia, 250252
        • Healthy Medical Center
    • Distrito Capital
      • Bogotá, Distrito Capital, Colombia, 110221
        • Medplus Centro de Recuperacion Integral S.A.S.
    • Distrito Capital De Bogotá
      • Bogotá, Distrito Capital De Bogotá, Colombia, 111111
        • Endocare Ltda.
    • Risaralda
      • Pereira, Risaralda, Colombia, 660003
        • Centro de Investigaciones Clinicas IPS Cardiomet Pereira
    • 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
    • Copenhagen
      • Hellerup, Copenhagen, Denmark, 2900
        • Steno Diabetes Center Copenhagen
    • København
      • Hvidovre, København, Denmark, 2605
        • Gastroenheden, Hvidovre Hospital
  • Germany
      • Hamburg, Germany, 22143
        • Clinical Research Hamburg
      • Hamburg, Germany, 22297
        • Israelitisches Krankenhaus
      • Hannover, Germany, 30459
        • KRH Klinikum Siloah
    • Baden-Wurttemberg
      • Karlsruhe, Baden-Wurttemberg, Germany, 76199
        • Klinische Forschung Karlsruhe GmbH
    • Saxony
      • Böhlen, Saxony, Germany, 4564
        • Studienzentrum Schwittay
      • Dresden, Saxony, Germany, 1309
        • Klinische Forschung Dresden Gmbh
  • Hungary
      • Budapest, Hungary, H1171
        • Strázsahegy Gyógyszertár Medicina
      • Szeged, Hungary, H-6720
        • Szegedi TudomanyegyetemSzent-Gyorgyi Albert Klinikai Kozpont és Altalanos Orvostudomanyi Kar Belgyogyaszati Klinika
    • Heves
      • Eger, Heves, Hungary, H-3300
        • Markhot Ferenc Oktatokorhaz és Rendelointezet
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hungary, H-5004
        • Hetenyi Geza Hospital
    • Zala
      • Zalaegerszeg, Zala, Hungary, H-8900
        • Zala Megyei Szent Rafael Korhaz
  • India
      • Delhi, India, 110060
        • Sir Ganga Ram Hospital (SGRH)
      • Mangalore, India, 575003
        • Vinaya Hospital & research Centre
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500072
        • Kumudini Devi Diabetes Research Center; Ramdevrao Hospital
      • Visakhapatnam, Andhra Pradesh, India, 530002
        • King George Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India, 380007
        • Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology
      • Ahmedabad, Gujarat, India, 380054
        • Zydus Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Lifecare Clinic and Research Centre - Internal Med/Diabetology
      • Bengaluru, Karnataka, India, 359-360
        • Diacon Hospital and research Center - Diabetology
      • Bengaluru, Karnataka, India, 560097
        • Rajalakshmi Hospital
      • Bengaluru, Karnataka, India, 560002
        • Victoria Hospital Bangalore Medical College and Research Institute
    • Maharashtra
      • Mumbai, Maharashtra, India, 400007
        • Bhatia Hospital
      • Pune, Maharashtra, India, 411001
        • B. J. Government Medical College and Sassoon General Hospitals
      • Pune, Maharashtra, India, 411011
        • Universal Hospital
      • Pune, Maharashtra, India, 411013
        • Noble Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • S R Kalla (SRK) Memorial Gastro & General Hospital
      • Jaipur, Rajasthan, India, 302012
        • Marudhar Hospital
      • Jaipur, Rajasthan, India, 302017
        • Eternal Hospital - Diabetology
      • Jaipur, Rajasthan, India, 302017
        • SMS Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600013
        • M.V. Hospital for Diabetes & Diabetes Research Centre
      • Coimbatore, Tamil Nadu, India, 641009
        • Kovai Diabetes Speciality Centre
      • Madurai, Tamil Nadu, India, 625020
        • Arthur Asirvatham Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • M V Hospital & Research Centre
  • Israel
      • Haifa, Israel, 31948
        • Bnei-Zion MC
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
    • Jeollabuk-Do
      • Jeonju, Jeollabuk-Do, Korea, Republic of, 561-712
        • Chonbuk National University Hospital
    • Nowon-gu
      • Seoul, Nowon-gu, Korea, Republic of, 1757
        • Sanggye Paik Hospital, Inje University College of Medicine
  • Latvia
      • Daugavpils, Latvia, LV5401
        • Polana-D
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
      • Riga, Latvia, 1006
        • Digestive Diseases Centre GASTRO
    • Kraslavas Nov.
      • Kraslava, Kraslavas Nov., Latvia, 5601
        • Kraslava Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Clinical Investigation Centre
      • Kubang Kerian, Malaysia, 16150
        • Clinical Trial Unit, School of Medical Sciences, Health Campus, Hospital Universiti Sains Malaysia
      • Taiping, Malaysia, 34000
        • Hospital Taiping
    • Kedah
      • Alor Setar, Kedah, Malaysia, 5460
        • Hospital Sultanah Bahiyah
  • 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
      • Durango, Mexico, 34270
        • CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)
      • Veracruz, Mexico, 91900
        • Sociedad de Metabolismo y Corazón S.C.
    • 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
      • Mexico, Distrito Federal, Mexico, 03300
        • Clinicos Asociados BOCM SC
      • Mexico DF, Distrito Federal, Mexico, 06700
        • Mentrials SA DE CV
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44150
        • Unidad de Investigacion Clinica Cardiometabolica de Occidente
      • Guadalajara, Jalisco, Mexico, 44210
        • Consultorio particular
      • Guadalajara, Jalisco, Mexico, 44670
        • Unidad de Investigación Clínica en Medicina S.C/
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Centro de Desarrollo Biomédico S.C.P
  • Philippines
      • Cebu City, Philippines, 6000
        • Perpetual Succor Hospital
      • Quezon City, Philippines, 1100
        • St. Luke's Medical Center
    • IloIlo
      • IloIlo City, IloIlo, Philippines, 5000
        • West Visayas State University Medical Center
    • Metro Manila
      • San Juan City, Metro Manila, Philippines, 1502
        • Cardinal Santos Medical Center
    • Metropolitan Manila
      • Manila, Metropolitan Manila, Philippines, 1000
        • Manila Doctors Hospital, Ermita
      • Pasay, Metropolitan Manila, Philippines, 1300
        • San Juan De Dios Educational Foundation, Inc.
    • NCR
      • Makati City, NCR, Philippines, 1218
        • Ospital ng Makati
  • Poland
      • Chojnice, Poland, 89-600
        • Centrum Medyczne Lukamed
    • Lesser Poland
      • Kraków, Lesser Poland, Poland, 30-539
        • Specjalistyczny Gabinet Neurologiczny Marta Banach
    • Malopolska
      • Krakow, Malopolska, Poland, 31-530
        • CenterMed Krakow Ltd
  • Russian Federation
      • Novosibirsk, Russian Federation, 630117
        • Scientific Institute of Clinical and Experimental Lymphology
      • Rostov on Don, Russian Federation, 344019
        • Rostov on Don
    • Leningrad Region
      • St-Petersburg, Leningrad Region, Russian Federation, 199106
        • Saint-Petersburg City Pokrovskaya Hospital
    • Saratov Region
      • Saratov, Saratov Region, Russian Federation, 410030
        • GUZ Saratov City Clinical Hospital 9
  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital
      • Singapore, Singapore, 119228
        • National University Hospital
      • Singapore, Singapore, S169856
        • Singapore General Hospital
  • South Africa
      • Somerset West, South Africa, 7130
        • Synexus Helderberg Clinical Research Centre
    • 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
    • Val De Grace
      • Pretoria, Val De Grace, South Africa, 0184
        • Watermeyer Clinical Research Site
  • Spain
      • Madrid, Spain, 28850
        • Hospital Universitario Príncipe de Asturias
  • Thailand
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
      • Bangkok, Thailand, 10700
        • Faculty of Medicine, Siriraj Hospital, Mahidol University
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
  • Ukraine
      • Chernivtsi, Ukraine, 58001
        • Chernivtsi Regional Clinical Hospital
      • Chernivtsi, Ukraine, 58022
        • Regional Municipal noncommercial Enterprise "Chernivtsi Regional Endocrinology Center", Polyclinic department, Higher State Educational Establishment of Ukraine "Bukovinian State Medical University", Department of Clinical Immunology, Allergology and Endo
      • Ivano-Frankivsk, Ukraine, 76008
        • Ivano-Frankivsk National Medical University
      • Ivano-Frankivsk, Ukraine, 76018
        • Ivano-Frankivsk Central City Clinical Hospital
      • Kharkiv, Ukraine, 61037
        • Municipal nonprofit entity of Kharkiv municipal council
      • Kharkiv, Ukraine, 61070
        • Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"
      • Kherson, Ukraine, 73000
        • Communal Institution Kherson City Clinical Hospital
      • Kyiv, Ukraine, 4050
        • Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit
      • Kyiv, Ukraine, 3049
        • Kyiv Railway Clinical Hospital No-2 of Branch of Healthcare Center of the PJSC Ukrainian Railway , Endocrynology Department
      • Odesa, Ukraine, 65010
        • Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University
      • Poltava, Ukraine, 36011
        • Poltava Regional Clinical Hospital
      • Vinnytsia, Ukraine, 21001
        • Private Small-Scale Enterprise Medical Centre Pulse
      • Vinnytsia, Ukraine, 21010
        • Vinnytsia Regional Clinical highly specialized Endocrinology Centre
      • Zaporizhzhia, Ukraine, 69035
        • Municipal Institution 6th City Clinical Hospital, Dept of Gastroenterology
    • Dnipropetrovs'ka Oblast'
      • Dnipro, Dnipropetrovs'ka Oblast', Ukraine, 49027
        • State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
    • Zaporizhzhia Region
      • Zaporizhzhia, Zaporizhzhia Region, Ukraine, 69600
        • Municipal Institution, City Hospital #7, polyclinic department, c. Zaporizhzhia
  • United Kingdom
      • Barnsley, United Kingdom, S75 3DL
        • MAC Research
      • Blackpool, United Kingdom, FY2 0JH
        • MAC Clinical Research, Kaman Court
      • Chelmsford, United Kingdom, CM1 7ET
        • Mid Essex Hospital Services NHS Trust Broomfield Hospital
      • Manchester, United Kingdom, M13 9NQ
        • MAC Clinical Research, GAC House
    • East Midland
      • Nottingham, East Midland, United Kingdom, NG7 2UH
        • Biomedical Research Centre
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9NQ
        • MAC Clinical Research Manchester
    • Lancashire
      • Oldham, Lancashire, United Kingdom, OL1 2JH
        • Royal Oldham Hospital
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L34 1BH
        • MAC Clinical Research
    • 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 Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS10 1DU
        • MAC Clinical Research, Monarch House
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group
      • Athens, Alabama, United States, 35611
        • North Alabama Research Center, LLC
      • Birmingham, Alabama, United States, 35211
        • Simon Williamson Clinic
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialist of the South East
      • Foley, Alabama, United States, 36535
        • G & L Research, LLC
      • Huntsville, Alabama, United States, 35801
        • Avant Research Associates
      • Mobile, Alabama, United States, 36608
        • Alabama Medical Group, PC
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Phoenix Clinical LLC.
      • Tucson, Arizona, United States, 85712
        • Del Sol Research Management, LLC
      • Tucson, Arizona, United States, 85710
        • Del Sol Research Management, LLC
      • Tucson, Arizona, United States, 85741
        • Synexus Clinical Research US, Inc.
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners, Inc.
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Gastroenterology
      • Searcy, Arkansas, United States, 72143
        • Unity Health - Searcy Medical Center
    • California
      • Canoga Park, California, United States, 91303
        • HOPE Clinical Research
      • Chula Vista, California, United States, 91910
        • GW Research Inc
      • Corona, California, United States, 92879
        • Kindred Medical Institute for Clinical Trials, LLC
      • Costa Mesa, California, United States, 92627
        • Aurora Care Clinic, LLC
      • El Cajon, California, United States, 92020
        • TriWest Research Associates
      • Encinitas, California, United States, 92024
        • Diagnamics Inc.
      • Garden Grove, California, United States, 92845
        • VVCRD Research
      • La Jolla, California, United States, 92037
        • University of California San Diego
      • Lancaster, California, United States, 93534
        • Om Research LLC
      • Lomita, California, United States, 90717
        • Torrance Clinical Research Institute, Inc.
      • Los Angeles, California, United States, 90057
        • Angel City Research Inc.
      • Palo Alto, California, United States, 94304
        • Stanford Hospital
      • San Diego, California, United States, 92123
        • Medical Associates Research Group, Inc
      • San Diego, California, United States, 92108
        • Optimal Research California
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
      • Upland, California, United States, 91786
        • Upland Clinical Research
      • Vista, California, United States, 92083
        • Synexus Clinical Research US, Inc.
      • Whittier, California, United States, 90603
        • New Hope Research Development
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
      • Colorado Springs, Colorado, United States, 80909
        • Synexus
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Gastroenterology Associates of Fairfield County, P.C.
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut, LLC
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida
      • Clearwater, Florida, United States, 33756
        • Innovative Research of West FL, Inc.
      • Cooper City, Florida, United States, 33024
        • ALL Medical Research, LLC
      • Cutler Bay, Florida, United States, 33189
        • Top Medical Research
      • Hialeah, Florida, United States, 33016
        • Palmetto Research, LLC
      • Homestead, Florida, United States, 33030
        • Vida Clinical Trials
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Miami, Florida, United States, 33134
        • APF Research LLC
      • Miami, Florida, United States, 33169
        • AMPM Research Clinic
      • Miami, Florida, United States, 33174
        • Advanced Medical Research Institute
      • Miami, Florida, United States, 33174
        • Florida Research Center, Inc.
      • Miami, Florida, United States, 33175
        • American Research Institute, INC
      • Miami Lakes, Florida, United States, 33014
        • Savin Medical Group LLC
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Of Naples
      • Ocoee, Florida, United States, 34761
        • Sensible Healthcare
      • Pinellas Park, Florida, United States, 33781
        • Synexus
    • Georgia
      • 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
      • Carnesville, Georgia, United States, 30521
        • Summit Clinical Research, LLC.
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta LLC
      • Riverdale, Georgia, United States, 30274
        • Infinite Clinical Trials
      • 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
      • Evanston, Illinois, United States, 60201
        • North Shore University Health System
      • Oak Lawn, Illinois, United States, 60453
        • Southwest Gastroenterology
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
      • Evansville, Indiana, United States, 47714
        • Synexus Clinical Research US, Inc.
      • Jeffersonville, Indiana, United States, 47130
        • American Research, LLC
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Pratt, Kansas, United States, 67124
        • Health Science Research Center
      • Shawnee Mission, Kansas, United States, 66217
        • Westglen Gastrointestinal Consultants
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center - Digestive Health
      • 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
      • Erlanger, Kentucky, United States, 41018
        • St. Elizabeth Healthcare â€" Clinical Research Institute
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • WK Physicians Network
      • Crowley, Louisiana, United States, 70526
        • Avant Research Associates LLC
      • Houma, Louisiana, United States, 70360
        • CroNola 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
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland
      • Frederick, Maryland, United States, 21701
        • Frederick Gastroenterology Associates, PA an Elligo Health Research Site
      • 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
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan
      • Dearborn, Michigan, United States, 48124
        • Vida Clinical Studies
      • Flint, Michigan, United States, 48504
        • Aa Mrc, Llc
      • Hamtramck, Michigan, United States, 48212
        • National Clinical, LLC
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan, West Michigan Clinical Research Center
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55446
        • MNGI Digestive Health
      • Richfield, Minnesota, United States, 55423
        • Synexus Clinical Research US, Inc.
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Synexus Clinical Research US, Inc
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Heartland Clinical Research, Inc
      • Omaha, Nebraska, United States, 68114
        • Diabetes and Endocrine Associates, P.C.
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Advanced Biomedical Research of America
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research
      • Las Vegas, Nevada, United States, 89128
        • Digestive Disease Specialists
      • Las Vegas, Nevada, United States, 89135
        • Palm Research Center
      • Las Vegas, Nevada, United States, 89121
        • Clinical Research of South Nevada - CROSN
    • New Jersey
      • Brick, New Jersey, United States, 08723
        • Garden State Endocrinology LLC
      • Bridgeton, New Jersey, United States, 08302
        • Synexus Clinical Research US, Inc.
      • Egg Harbor Township, New Jersey, United States, 08234
        • AGA Clinical Research Associates, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Lovelace Scientific Resources, Inc.
    • New York
      • Bronx, New York, United States, 10455
        • CHEAR Center LLC
      • Great Neck, New York, United States, 11023
        • Long Island Gastrointestinal Research Group LLP
      • Johnson City, New York, United States, 13790
        • United Health Services Hospitals, Inc.
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates
      • Chapel Hill, North Carolina, United States, 27599-7080
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Healthcare-Charlotte
      • Concord, North Carolina, United States, 28025
        • Carolina Digestive Health Associates, PA
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates, LLC
      • Greensboro, North Carolina, United States, 27410
        • Triad Clinical Trials
      • Kinston, North Carolina, United States, 28501
        • Vidant Multispeciality Clinic - Kinston
      • Morehead City, North Carolina, United States, 28557
        • Diabetes and Endocrinology Consultants, PC
      • Salisbury, North Carolina, United States, 28144
        • PMG Research Salisbury
      • Wilmington, North Carolina, United States, 28403
        • Trial Management Associates, LLC
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research
    • Ohio
      • Akron, Ohio, United States, 44311
        • Synexus Clinical Research US, Inc.
      • Beavercreek, Ohio, United States, 45440
        • Dayton Gastroenterology,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
      • Columbus, Ohio, United States, 43201
        • Endocrinology Research Associates, Inc.
      • Columbus, Ohio, United States, 43214
        • Hometown Urgent Care and Research
      • 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.
      • Franklin, Ohio, United States, 45005
        • Premier Clinical Research d.b.a. STAT Research
      • Wadsworth, Ohio, United States, 44281
        • Family Practice Center of Wadsworth, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Digestive Disease Specialists Inc
      • Oklahoma City, Oklahoma, United States, 73120
        • Memorial Clinical Research
      • Oklahoma City, Oklahoma, United States, 73111
        • Centennial Health-Synexus
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Gastroenterology Clinic, LLC
    • Pennsylvania
      • Levittown, Pennsylvania, United States, 19056
        • Family Medical Associates, Research Department
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians, Inc.
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Endocrinology Associates
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinical Research
      • Scottdale, Pennsylvania, United States, 15683
        • Frontier Clinical Research, LLC
      • Smithfield, Pennsylvania, United States, 15478
        • Frontier Clinical Research, LLC
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Synexus Clinical Research US, Inc.
      • Anderson, South Carolina, United States, 29621
        • Synexus Clinical Research US, Inc
      • Charleston, South Carolina, United States, 29406
        • Clinical Trials of South Carolina
      • Clinton, South Carolina, United States, 29325
        • Carolina Medical Research
      • Greenville, South Carolina, United States, 29615
        • Gastroenterology Associates, PA
      • Greer, South Carolina, United States, 29650
        • Synexus Clinical Research
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • ClinSearch
      • Germantown, Tennessee, United States, 38138
        • Gastroenterology Centers of the Midsouth
      • Johnson City, Tennessee, United States, 37604
        • East Tennessee Research Institute
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute, LLC
      • Beaumont, Texas, United States, 77701
        • DiscoveResearch, Inc.
      • 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
      • Houston, Texas, United States, 77089
        • Amir Hassan, MD, PA
      • Kerrville, Texas, United States, 78028
        • Sante Clinical Research
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • 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, 78229
        • Sagact Pllc.
    • Utah
      • Layton, Utah, United States, 84041
        • Synexus Clinical Research US, Inc.
      • Murray, Utah, United States, 84123
        • Synexus Clinical Research US, Inc.
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute, Inc.
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Verity Research Inc.
      • 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
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Two different groups of participants may enter into the study:

  1. Rollover Participants

    Participants who were not randomization-eligible at the end of the Run-in Period of lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be randomized in the study if all of the following criteria apply:

    •In the lead-in studies, participants must have met all screening visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary (DGSSD)) except that:

    • They had zero vomiting episodes and an average daily Diabetic Gastroparesis Symptom Severity Score (DGSSS) of ≥12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device; OR
    • They had vomiting episodes and an average daily DGSSS of ≥12 but <16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device

  2. De Novo Participants

    • Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) of at least 5 years' duration, with controlled and stable blood glucose levels and hemoglobin A1c (HBA1c) ≤11%
    • DG defined as at least a 3-month history prior to Screening of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of gastroparesis (GP) (e.g., nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety)
    • Compliance with the entry of data into the hand-held electronic device during the Run-in Period
    • Compliance with administration of subcutaneous (SC) twice daily injections during the Run-in Period
    • The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12

Exclusion Criteria:

  1. Both Rollover and De Novo Participants

    •Participants with a known allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)

  2. Rollover Participants

    •Participants will be excluded from this study if any of the lead-in study exclusion criteria apply at the Screening Visit and at the end of the Run-in Period for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria

  3. De Novo Participants

    • History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of the Screening Visit
    • History of intestinal malabsorption or pancreatic exocrine insufficiency
    • History of belching disorders, other nausea and vomiting disorders
    • Gastric or duodenal ulcer within 3 months of Screening
    • History of malignancy in the 3 years prior to Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
    • Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression
    • Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (e.g., erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI promotility agents for at least 10 days prior to the start of the Run-in Period
    • Currently taking opiates, or expecting to use opiates during the course of the clinical study
    • Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period
    • History of pyloric injection of botulinum toxin within 6 months of screening
    • History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)
    • Randomization in any previous study in which relamorelin was a treatment
    • Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the gastric emptying breath test (GEBT) study meal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Drug: Placebo
Placebo injected subcutaneously twice daily.
Experimental: Relamorelin 10 μg
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Drug: Relamorelin
Relamorelin 10 μg injected subcutaneously twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study
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 of the previous study or the run-in period of this study for new participants.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study
Change From Baseline to Week 52 in the Weekly Average DGSSS
Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study
Participants assessed the severity of diabetic gastroparesis symptoms daily using the 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). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
Time Frame: First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks)
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.
First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks)
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Time Frame: Up to 52 weeks
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 participant had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Up to 52 weeks
Number of Participants With Clinically Meaningful Trends for Vital Signs
Time Frame: Up to 52 weeks
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 52 weeks
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Time Frame: Up to 52 weeks
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Up to 52 weeks
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c)
Time Frame: Up to 52 weeks
Up to 52 weeks
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
Time Frame: Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364)
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 84, Day 364, and End of Treatment (Up to Day 364)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Harvy Schneier, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

November 5, 2020

Study Completion (Actual)

November 5, 2020

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RLM-MD-04
  • 2017-002144-33 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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