A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

November 24, 2021 updated by: Allergan

A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

467

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
      • Ciudad Autonoma de Buenos Aires, Argentina, 1119
        • CIPREC
      • Corrientes, Argentina, W3410AVV
        • Centro Universitario de Investigación en Farmacologia Clínic
    • 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
    • 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 Hematología y Medicina Clínica Dr. Rubén Dávoli
    • 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
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Austria
      • Salzburg, Austria, 5020
        • Privatklinik Wehrle-Diakonissen
      • Steyr, Austria, 4400
        • Landeskrankenhaus Steyr
    • Styria
      • Sankt Stefan ob Stainz, Styria, 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
      • Belém, Brazil, 66073-000
        • Hospital Universitário João de Barros Barreto
      • Sao Paulo, Brazil, 01223-001
        • IPEC-Instituto de Pesquisa Clinica
    • Ceara
      • Fortaleza, Ceara, Brazil, 60430-370
        • Hospital Universitario Walter Cantidio
    • Ceará
      • Fortaleza, Ceará, Brazil, 60160-230
        • Instituto de Estudos e Pesquisas Clinicas do Ceará IEP/CE - Oncology
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 71625175
        • Centro de Pesquisa Clinica do Brasil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
        • Núcleo de Pesquisa Clínica 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, 13060904
        • Instituto de Pesquisa Clínica de Campinas
    • São Paulo
      • Santa Cecília, São Paulo, Brazil, 01228-000
        • Cpquali Pesquisa Clinica Ltda
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • UMHAT - Kaspela- EOOD
    • Ruse
      • Byala, Ruse, Bulgaria, 7100
        • MHAT Yuliya Vrevska Byala
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2E1
        • Alberta Diabetes Institute
      • Red Deer, Alberta, Canada, T4N 6V7
        • Central Alberta Research Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Nova Scotia
      • Bridgewater, Nova Scotia, Canada, B4V 2V6
        • South Shore Medical Arts
    • Ontario
      • Ottawa, Ontario, Canada, K1H 7W9
        • The Ottawa Hospital
      • Vaughan, Ontario, Canada, L4L 4YZ
        • Toronto Digestive Disease Associates
    • 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
        • Fundacion BIOS
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 111111
        • Endocare Ltda.
      • Zipaquirá, Cundinamarca, Colombia, 250252
        • Healthy Medical Center
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 110221
        • Medplus Medicina Prepagada
    • Distrito Capital De Bogotá
      • Teusaquillo, Distrito Capital De Bogotá, Colombia, 111311
        • Asociación Colombiana de Diabetes
    • 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, 760001
        • Centro Medico Imbanaco de Cali S.A.
  • Denmark
    • Copenhagen
      • Hellerup, Copenhagen, Denmark, 2900
        • Gentofte Hospital
      • Hvidovre, Copenhagen, Denmark, 2650
        • Gastroenheden, Hvidovre Hospital
  • Germany
      • Hamburg, Germany, 22143
        • Clinical Research Hamburg
      • Hamburg, Germany, 22297
        • Israelitisches Krankenhaus
      • Hannover, Germany, 30459
        • KRH Klinikum Siloah
    • Baden-Wuertemberg
      • Karlsruhe, Baden-Wuertemberg, Germany, 76137
        • 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
    • Csonfrád
      • Szeged, Csonfrád, Hungary, 6720
        • First Department of Medicine, University of Szeged
    • Heves
      • Eger, Heves, Hungary, H-3300
        • Markhot Ferenc Oktatokorhaz Es Rendelointezet
    • Jász-Nagykun-Szolnok
      • Tószeg, Jász-Nagykun-Szolnok, Hungary, H-5004
        • HETENYI Geza Hospital
    • Zala
      • Zalaegerszeg, Zala, Hungary, H-8900
        • Zala Megyei Szent Rafael Kórház
  • India
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
    • 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
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Victoria Hospital
      • Bangalore, Karnataka, India, 560092
        • Life Care Hospital & Research Centre
      • Bengaluru, Karnataka, India, 359-360
        • Diacon Hospital and research Center - Diabetology
      • Bengaluru, Karnataka, India, 560097
        • Rajalakshmi Hospital
      • Mangalore, Karnataka, India, 575003
        • Vinaya Hospital & research Centre
    • 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, 302006
        • Diabetic Thyroid and Endocrine Centre
      • Jaipur, Rajasthan, India, 302012
        • Marudhar Hospital
      • Jaipur, Rajasthan, India, 302017
        • Eternal Hospital - Diabetology
      • Jaipur, Rajasthan, India, 302017
        • SMS Hospital
      • Jaipur, Rajasthan, India, 302001
        • S.R. Kalla (SRK) Memorial Gastro & General Hospital
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641009
        • Kovai Diabetes Speciality Centre
      • Madurai, Tamil Nadu, India, 625020
        • Arthur Asirvatham Hospital
    • Uttar Prandesh
      • Lucknow, Uttar Prandesh, India, 226003
        • M. V Hospital & Research Centre
  • Israel
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Safed, Israel, 13100
        • Endocrinology & Diabetes Center
  • 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, 01757
        • Diabetes Center
  • 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
      • Kubang Kerian, Malaysia, 16150
        • 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
      • Veracruz, Mexico, 91900
        • Sociedad de Metabolismo y Corazon, S.C.
    • Cdmx
      • Cuauhtemoc, Cdmx, Mexico, 06700
        • Mentrials SA DE CV
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 11650
        • Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology
      • Mexico, Distrito Federal, Mexico, 03300
        • Clinicos Asociados BOCM SC
    • Guillermina
      • Durango, Guillermina, Mexico, 34270
        • Centro de Investigación y Atención de Diabetes - Endocrinología y Nutrición
    • Jalisco
      • Guadalajara, Jalisco, Mexico, C.P. 44210
        • Consultorio Médico
      • Guadalajara, Jalisco, Mexico, C.P. 44670
        • Unidad de Investigacion Clinica en Medicina S.C.
      • Guadalajara, Jalisco, Mexico, 44150
        • Unidad de Investigacion Clinica Cardiometabolica de Occidente, S.C.
    • Mexico DF
      • Mexico, Mexico DF, Mexico, 14000
        • Centro de Atención e Investigación en Factores de Riesgo Car
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Centro de Desarrollo Biomédico S.C.P
  • Philippines
      • Cebu City, Philippines, 6000
        • Perpetual Succor Hospital
    • IloIlo
      • IloIlo City, IloIlo, Philippines, 5000
        • West Visayas State University Medical Center
    • Metro Manila
      • Quezon City, Metro Manila, Philippines, 1100
        • St. Luke's Medical Center
      • 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
      • Krakow, Poland, 30-539
        • Specjalistyczny Gabinet Neurologiczny Marta Banach
      • Wroclaw, Poland, 51-162
        • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
    • Podlaski
      • Bialystok, Podlaski, Poland, 15-798
        • NZOZ Vita Diabetica - Malgorzata Buraczyk
    • Pomorskie
      • Sopot, Pomorskie, Poland, 81-756
        • ENDOSKOPIA Sp. z o.o.
  • Russian Federation
      • Kazan, Russian Federation, 420100
        • 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
      • Saratov, Russian Federation, 410039
        • Saratov City Clinical Hospital 12
      • Saratov, Russian Federation, 410030
        • GUZ Saratov City Clinical Hospital 9
    • Leningrad Region
      • St-Petersburg, Leningrad Region, Russian Federation, 199106
        • Saint-Petersburg City Pokrovskaya Hospital
    • Novosibirskaya Oblast
      • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630117
        • Scientific Institute of Clinical and Experimental Lymphology
    • Sankt-Peterburg
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 191015
        • North-Western State Medical University named after I. I. Mechnikov
    • Volga
      • Nizhny Novgorod, Volga, Russian Federation, 603126
        • Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko
  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital
      • Singapore, Singapore, 119228
        • National University Hospital
      • Singapore, Singapore, 169856
        • Singapore General Hospital
  • South Africa
    • 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 Clincal Reaserch Centre
      • Pretoria, Gauteng, South Africa, 0184
        • Watermeyer Clinical Research Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
        • Synexus Helderberg Clinical Research Centre
  • 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
        • Regional muniRegional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious
      • Chernivtsi, Ukraine, 58022
        • Regional Public Organization "Chernivtsi Regional Endocrinology Center"
      • Dnipro, Ukraine, 49027
        • State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
      • Kharkiv, Ukraine, 61037
        • Municipal nonprofit entity of Kharkiv municipal council
      • Kharkiv, Ukraine, 61039
        • L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine
      • 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, 2002
        • Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv
      • Kyiv, Ukraine, 4050
        • Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit
      • Kyiv, Ukraine, 3049
        • Kyiv clinical hospital on railway transport #2 of the "Healthcare Centre" branch of JSC "Ukrainian Railway"
      • Kyiv, Ukraine, 3057
        • Medical Center Universal Clinic Oberig
      • Odesa, Ukraine, 65010
        • Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University
      • Odesa, Ukraine, 65025
        • Communal Institution "Odesa Regional Clinical Hospital", Out-patient department
      • Poltava, Ukraine, 36011
        • Poltava Regional Clinical Hospital
      • Ternopil, Ukraine, 46000
        • Ternopil University Hospital
      • Vinnytsia, Ukraine, 21001
        • Private Small-Scale Enterprise Medical Centre Pulse
      • Vinnytsia, Ukraine, 21010
        • Vinnytsia Regional Clinical highly specialized Endocrinology Centre
      • Vinnytsia, Ukraine, 21029
        • Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia
      • Zaporizhzhia, Ukraine, 69035
        • 6th City Clinical Hospital, c. Zaporizhzhia
      • Zaporizhzhia, Ukraine, 69600
        • Municipal Institution, City Hospital #7
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76008
        • Ivano-Frankivsk National Medical University
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
        • Ivano-Frankivsk Central City Clinical Hospital
  • 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
      • Liverpool, United Kingdom, L34 1BH
        • MAC Clinical Research
      • Stockton-on-Tees, United Kingdom, TS17 6EW
        • 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
    • Staffordshire
      • Cannock, Staffordshire, United Kingdom, WS11 0BH
        • MAC Research, Exchange House
    • 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
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialist of the South East
      • Foley, Alabama, United States, 36535
        • G & L Research, LLC
      • Mobile, Alabama, United States, 36608
        • Alabama Medical Group, PC
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Del Sol Research Management, LLC
      • Phoenix, Arizona, United States, 85014
        • Phoenix Clinical LLC.
      • Tucson, Arizona, United States, 85712
        • Del Sol Research Management, LLC
    • 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
      • 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, 90026
        • Angel City Research Inc.
      • Poway, California, United States, 92064
        • Triwest Research Associates
      • San Diego, California, United States, 92123
        • Medical Associates Research Group, Inc
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
      • Upland, California, United States, 91786
        • Upland Clinical Research
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
      • Colorado Springs, Colorado, United States, 80909
        • Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Gastroenterology Associates of Fairfield County, P.C.
    • District of Columbia
      • Washington, District of Columbia, United States, 20017
        • TrialSpark, Inc.
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida
      • Clearwater, Florida, United States, 33756
        • Innovative Research of West FL, Inc.
      • Clearwater, Florida, United States, 33756
        • West Central Gastroenterology
      • 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
      • Miami Lakes, Florida, United States, 33014
        • Panax Clinical Research, LLC.
      • Pinellas Park, Florida, United States, 33781
        • Synexus
    • 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
      • 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
      • Oak Lawn, Illinois, United States, 60453
        • Southwest Gastroenterology
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
      • 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, 67214
        • 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
      • Crestview Hills, Kentucky, United States, 41017
        • Tri-State Gastroenterology
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • Delta Research Partners
      • 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
      • Metairie, Louisiana, United States, 70006
        • New Orleans Research Institute - Metropolitan Gastroenterology Associates
      • West Monroe, Louisiana, United States, 71291
        • Clinical Trials of America, Inc.
    • Maryland
      • Bowie, Maryland, United States, 20716
        • Trialspark - Silverman
      • 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.
      • 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
      • 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
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55446
        • Minnesota Gastroenterology, P.A.
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Heartland Clinical Research, Inc
      • Omaha, Nebraska, United States, 68114
        • Methodist Physicians Clinic Diabetes and Endocrine Specialists
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Clinical Research of South Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center
      • 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
    • New Jersey
      • Brick, New Jersey, United States, 08723
        • Garden State Endocrinology
      • 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
      • Great Neck, New York, United States, 11023
        • Long Island Gastrointestinal Research Group LLP
      • Jamaica, New York, United States, 11432
        • Synexus Clinical Research US, Inc.
      • 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
      • 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
      • 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
      • 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. DBA New Venture Medical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Digestive Disease Specialists Inc
      • Oklahoma City, Oklahoma, United States, 73120
        • Memorial Clinical Research
      • 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
      • Smithfield, Pennsylvania, United States, 15478
        • Montgomery Medical, Inc.
      • 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
      • Greenville, South Carolina, United States, 29615
        • Gastroenterology Associates, PA
    • 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
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute, LLC
      • Austin, Texas, United States, 78704
        • Avant Research Associates,LLC
      • Carrollton, Texas, United States, 75007
        • ClinRx Research, LLC
      • Dallas, Texas, United States, 75234
        • Synexus Clinical Research US, Inc.
      • Houston, Texas, United States, 77089
        • Amir Ali Hassan, MD, PA
      • 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
        • Southern Star Research Institute, LLC
      • 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
    • Utah
      • 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.
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Centre
      • Woodbridge, Virginia, United States, 22192
        • Cardinal Internal Medicine Associates, PC
    • 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:

  • Participants are eligible to be included in the study only if all the following criteria apply:
  • Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
  • Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
  • In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02

Exclusion Criteria:

  • Participants are excluded from the study if any of the following criteria apply:
  • Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
  • Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
  • Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
  • Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Treatment Period: Placebo
Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.
Drug: Placebo
Placebo injected twice daily
EXPERIMENTAL: Treatment Period: Relamorelin 10 μg
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.
Drug: Relamorelin
Relamorelin 10 μg injected twice daily
EXPERIMENTAL: Randomized Withdrawal Period: Placebo then Relamorelin 10 μg
Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.
Drug: Placebo
Placebo injected twice daily
Drug: Relamorelin
Relamorelin 10 μg injected twice daily
EXPERIMENTAL: Randomized Withdrawal Period: Relamorelin 10 μg then Relamorelin 10 μg
Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.
Drug: Relamorelin
Relamorelin 10 μg injected twice daily
EXPERIMENTAL: Randomized Withdrawal Period: Relamorelin 10 μg then Placebo
Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Drug: Placebo
Placebo injected twice daily
Drug: Relamorelin
Relamorelin 10 μg injected 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) of the Treatment Period
Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) 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 in the previous studies.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Time Frame: Week 6 to Week 12
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 first 12-weeks of the 40-week Treatment Period.
Week 6 to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
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 first 12-weeks of the 40-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 was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
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 first 12-weeks of the 40-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 was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
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 first 12-weeks of the 40-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 was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
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 first 12-weeks of the 40-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 was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period
Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages (Week 37 to Week 40) 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 studies.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period
Time Frame: Week 37 to Week 40
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 the last 4 weeks of the 40-week Treatment Period.
Week 37 to Week 40
Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period
Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
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. The average weekly number of vomiting episodes were derived as the average of the weekly number of vomiting episodes in the last 4 weeks of the 40-week Treatment Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period
Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an 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). Average weekly scores are derived as the average of the weekly scores from the 6 weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period
Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
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. Average weekly number of vomiting episodes are derived as the average of the weekly number of vomiting episodes from the six weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
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 50 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 50 weeks)
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Time Frame: Up to 46 weeks
Clinical Laboratory values 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 46 weeks
Number of Participants With Clinically Meaningful Trends for Vital Signs
Time Frame: Up to 46 weeks
Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the results were clinically significant.
Up to 46 weeks
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Time Frame: Up to 46 weeks
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Up to 46 weeks
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Time Frame: Up to 46 weeks
Up to 46 weeks
Number of Participants With Anti-relamorelin Antibody Testing Results
Time Frame: Up to 46 weeks
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.
Up to 46 weeks

Collaborators and Investigators

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

Sponsor

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)

January 24, 2018

Primary Completion (ACTUAL)

October 30, 2020

Study Completion (ACTUAL)

October 30, 2020

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

February 1, 2018

First Posted (ACTUAL)

February 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RLM-MD-03

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.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe