AzTrials
AzTrials

GastroparesisPhase 3NCT03420781

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

A Phase 3 study testing Relamorelin in people with Gastroparesis and Diabetes Mellitus, run by Allergan at 337 sites in 26 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastroparesis, Diabetes Mellitus
What is being tested?
Relamorelin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
467 participants
Where
337 sitesin 26 countries
Study dates
24 Jan 2018to 30 Oct 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

337 sites in 26 countries.

337 sites in 26 countries

United States161 sites

  • Lovelace Scientific Resources, Inc.

    Albuquerque, New Mexico, 87108

  • Synexus Clinical Research US, Inc.

    Anderson, South Carolina, 29621

  • Synexus Clinical Research US, Inc

    Anderson, South Carolina, 29621

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Asheville Gastroenterology Associates

    Asheville, North Carolina, 28801

  • North Alabama Research Center, LLC

    Athens, Alabama, 35611

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Emory University

    Atlanta, Georgia, 30322

  • Avant Research Associates,LLC

    Austin, Texas, 78704

  • Delta Research Partners

    Bastrop, Louisiana, 71220

  • Dayton Gastroenterology, Inc.

    Beavercreek, Ohio, 45440

  • River Birch Research Alliance, LLC

    Blue Ridge, Georgia, 30513

  • WK Physicians Network

    Bossier City, Louisiana, 71111

  • Trialspark - Silverman

    Bowie, Maryland, 20716

  • Garden State Endocrinology

    Brick, New Jersey, 08723

  • Gastroenterology Associates of Fairfield County, P.C.

    Bridgeport, Connecticut, 06606

  • Commonwealth Clinical Studies, PLLC.

    Brockton, Massachusetts, 02302

  • Gwinnett Research Institute, LLC

    Buford, Georgia, 30519

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Diabetes & Endocrinology Associates of Stark County, Inc.

    Canton, Ohio, 44718

  • Summit Clinical Research, LLC.

    Carnesville, Georgia, 30521

  • ClinRx Research, LLC

    Carrollton, Texas, 75007

  • Del Sol Research Management, LLC

    Chandler, Arizona, 85224

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7080

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Clinsearch

    Chattanooga, Tennessee, 37421

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan, 48047

  • GW Research Inc

    Chula Vista, California, 91910

  • Synexus Clinical Research US - Cincinnati

    Cincinnati, Ohio, 45236

  • Innovative Research of West FL, Inc.

    Clearwater, Florida, 33756

  • West Central Gastroenterology

    Clearwater, Florida, 33756

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Synexus Clinical Research US, Inc. - Colorado Springs Family Practice

    Colorado Springs, Colorado, 80909

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • Endocrinology Research Associates, Inc.

    Columbus, Ohio, 43201

  • The Ohio State University, Wexner Medical Center

    Columbus, Ohio, 43203

  • Aventiv Research, Inc.

    Columbus, Ohio, 43213

  • Hometown Urgent Care and Research

    Columbus, Ohio, 43214

  • Carolina Digestive Health Associates, PA

    Concord, North Carolina, 28025

  • Minnesota Gastroenterology, P.A.

    Coon Rapids, Minnesota, 55446

  • ALL Medical Research LLC

    Cooper City, Florida, 33024

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Aurora Care Clinic, LLC

    Costa Mesa, California, 92627

  • Tri-State Gastroenterology

    Crestview Hills, Kentucky, 41017

  • Avant Research Associates LLC

    Crowley, Louisiana, 70526

  • Top Medical Research

    Cutler Bay, Florida, 33189

  • Synexus Clinical Research US, Inc.

    Dallas, Texas, 75234

  • CIC America Clinical Inquest Center Ltd.

    Dayton, Ohio, 45409

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45424

  • Vida Clinical Studies

    Dearborn, Michigan, 48124

  • iResearch Atlanta LLC

    Decatur, Georgia, 30030

  • Digestive Health Specialist of the South East

    Dothan, Alabama, 36305

  • AGA Clinical Research Associates LLC

    Egg Harbor, New Jersey, 08234

  • Diagnamics Inc.

    Encinitas, California, 92024

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Verity Research Inc.

    Fairfax, Virginia, 22031

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • G & L Research, LLC

    Foley, Alabama, 36535

  • Premier Clinical Research d.b.a. STAT Research

    Franklin, Ohio, 45005

  • Frederick Gastroenterology Associates, PA an Elligo Health Research Site

    Frederick, Maryland, 21701

  • VVCRD Research

    Garden Grove, California, 92845

  • Gastro One

    Germantown, Tennessee, 38138

  • Woodholme Gastroenterology Associates, P.A.

    Glen Burnie, Maryland, 21061

  • Long Island Gastrointestinal Research Group LLP

    Great Neck, New York, 11023

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410

  • Gastroenterology Associates, PA

    Greenville, South Carolina, 29615

  • National Clinical, LLC

    Hamtramck, Michigan, 48212

  • Palmetto Research, LLC

    Hialeah, Florida, 33016

  • Vida Clinical Trials

    Homestead, Florida, 33030

  • Cronola LLC

    Houma, Louisiana, 70360

  • Biopharma Informatic Inc., Research Center

    Houston, Texas, 77043

  • Rodriguez Clinical Trials

    Houston, Texas, 77083

  • Amir Ali Hassan, MD, PA

    Houston, Texas, 77089

  • Rocky Mountain Diabetes and Osteoporosis Center, PA

    Idaho Falls, Idaho, 83404-7596

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Synexus Clinical Research US, Inc.

    Jamaica, New York, 11432

  • American Research, LLC

    Jeffersonville, Indiana, 47130

  • United Health Services Hospitals, Inc.

    Johnson City, New York, 13790

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Sante Clinical Research

    Kerrville, Texas, 78028

  • Vidant Multispeciality Clinic - Kinston

    Kinston, North Carolina, 28501

  • University of California San Diego

    La Jolla, California, 92037

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana, 70601

  • Om Research LLC

    Lancaster, California, 93534

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89121

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Digestive Disease Specialists

    Las Vegas, Nevada, 89128

  • Palm Research Center

    Las Vegas, Nevada, 89148

  • Family Medical Associates, Research Department

    Levittown, Pennsylvania, 19056

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212

  • Torrance Clinical Research Institute, Inc.

    Lomita, California, 90717

  • Angel City Research Inc.

    Los Angeles, California, 90026

  • University of Louisville

    Louisville, Kentucky, 40202

  • Manassas Clinical Research Centre

    Manassas, Virginia, 20110

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • New Orleans Research Institute - Metropolitan Gastroenterology Associates

    Metairie, Louisiana, 70006

  • APF Research LLC

    Miami, Florida, 33134

  • AMPM Research Clinic

    Miami, Florida, 33169

  • Advanced Medical Research Institute

    Miami, Florida, 33174

  • Florida Research Center, Inc.

    Miami, Florida, 33174

  • American Research Institute, Inc

    Miami, Florida, 33175

  • Panax Clinical Research, LLC.

    Miami Lakes, Florida, 33014

  • Savin Medical Group LLC

    Miami Lakes, Florida, 33014

  • Montana Medical Research

    Missoula, Montana, 59808

  • Alabama Medical Group, PC

    Mobile, Alabama, 36608

  • Diabetes and Endocrinology Consultants, PC

    Morehead City, North Carolina, 28557

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Quality Medical Research

    Nashville, Tennessee, 37211

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453

  • Advanced Research Institute, Inc.

    Ogden, Utah, 84405

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma, 73112

  • Memorial Clinical Research

    Oklahoma City, Oklahoma, 73120

  • Methodist Physicians Clinic Diabetes and Endocrine Specialists

    Omaha, Nebraska, 68114

  • Heartland Clinical Research, Inc

    Omaha, Nebraska, 68134

  • Phoenix Clinical LLC.

    Phoenix, Arizona, 85014

  • Synexus

    Pinellas Park, Florida, 33781

  • Allegheny Endocrinology Associates

    Pittsburgh, Pennsylvania, 15212

  • Preferred Primary Care Physicians, Inc.

    Pittsburgh, Pennsylvania, 15236

  • Northwest Gastroenterology Clinic, LLC

    Portland, Oregon, 97210

  • TriWest Research Associates

    Poway, California, 92064

  • Health Science Research Center

    Pratt, Kansas, 67124

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Infinite Clinical Trials

    Riverdale, Georgia, 30274

  • Meridian Clinical Research, LLC

    Rockville, Maryland, 20854

  • PMG Research Salisbury

    Salisbury, North Carolina, 28144

  • Pinnacle Clinical Research

    San Antonio, Texas, 78215

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

  • Synexus Clinical Research US, Inc.

    San Antonio, Texas, 78229

  • Medical Associates Research Group, Inc

    San Diego, California, 92123

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Unity Health - Searcy Medical Center

    Searcy, Arkansas, 72143

  • WestGlen Gastrointestinal Consultants

    Shawnee Mission, Kansas, 67214

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478

  • Montgomery Medical, Inc.

    Smithfield, Pennsylvania, 15478

  • Clinical Research Consultants of Atlanta

    Suwanee, Georgia, 30024

  • Washington Gastroenterology PLLC

    Tacoma, Washington, 98405

  • Cotton-O'Neil Clinical Research Center - Digestive Health

    Topeka, Kansas, 66606

  • Kansas Medical Clinic

    Topeka, Kansas, 66606

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85712

  • Options Health Research, LLC

    Tulsa, Oklahoma, 74104

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Upland Clinical Research

    Upland, California, 91786

  • Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research

    Wadsworth, Ohio, 44281

  • TrialSpark, Inc.

    Washington D.C., District of Columbia, 20017

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Clinical Trials of America, Inc.

    West Monroe, Louisiana, 71291

  • Professional Research Network of Kansas, LLC

    Wichita, Kansas, 67205

  • Via Christi Clinic, PA

    Wichita, Kansas, 67208

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

  • Cardinal Internal Medicine Associates, PC

    Woodbridge, Virginia, 22192

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan, 49519

Other trials in United States

Ukraine22 sites

  • 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, 58001

  • Regional Public Organization "Chernivtsi Regional Endocrinology Center"

    Chernivtsi, 58022

  • State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine

    Dnipro, 49027

  • Ivano-Frankivsk National Medical University

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008

  • Ivano-Frankivsk Central City Clinical Hospital

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Municipal nonprofit entity of Kharkiv municipal council

    Kharkiv, 61037

  • L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine

    Kharkiv, 61039

  • Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"

    Kharkiv, 61070

  • Communal Institution Kherson City Clinical Hospital

    Kherson, 73000

  • Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv

    Kyiv, 2002

  • Kyiv clinical hospital on railway transport #2 of the "Healthcare Centre" branch of JSC "Ukrainian Railway"

    Kyiv, 3049

  • Medical Center Universal Clinic Oberig

    Kyiv, 3057

  • Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit

    Kyiv, 4050

  • Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University

    Odesa, 65010

  • Communal Institution "Odesa Regional Clinical Hospital", Out-patient department

    Odesa, 65025

  • Poltava Regional Clinical Hospital

    Poltava, 36011

  • Ternopil University Hospital

    Ternopil, 46000

  • Private Small-Scale Enterprise Medical Centre Pulse

    Vinnytsia, 21001

  • Vinnytsia Regional Clinical highly specialized Endocrinology Centre

    Vinnytsia, 21010

  • Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia

    Vinnytsia, 21029

  • 6th City Clinical Hospital, c. Zaporizhzhia

    Zaporizhzhya, 69035

  • Municipal Institution, City Hospital #7

    Zaporizhzhya, 69600

Other trials in Ukraine

India21 sites

  • Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre

    Ahmedabad, Gujarat, 380007

  • Victoria Hospital

    Bangalore, Karnataka, 560002

  • Life Care Hospital & Research Centre

    Bangalore, Karnataka, 560092

  • Diacon Hospital and research Center - Diabetology

    Bengaluru, Karnataka, 359-360

  • Rajalakshmi Hospital

    Bengaluru, Karnataka, 560097

  • Kovai Diabetes Speciality Centre

    Coimbatore, Tamil Nadu, 641009

  • Kumudini Devi Diabetes Research Center; Ramdevrao Hospital

    Hyderabad, Andhra Pradesh, 500072

  • S.R. Kalla (SRK) Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302001

  • Diabetic Thyroid and Endocrine Centre

    Jaipur, Rajasthan, 302006

  • Marudhar Hospital

    Jaipur, Rajasthan, 302012

  • Eternal Hospital - Diabetology

    Jaipur, Rajasthan, 302017

  • SMS Hospital

    Jaipur, Rajasthan, 302017

  • M. V Hospital & Research Centre

    Lucknow, Uttar Prandesh, 226003

  • Arthur Asirvatham Hospital

    Madurai, Tamil Nadu, 625020

  • Vinaya Hospital & Research Centre

    Mangalore, Karnataka, 575003

  • Bhatia Hospital

    Mumbai, Maharashtra, 400007

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • B. J. Government Medical College and Sassoon General Hospitals

    Pune, Maharashtra, 411001

  • Universal Hospital

    Pune, Maharashtra, 411011

  • Noble Hospital

    Pune, Maharashtra, 411013

  • King George Hospital

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Mexico13 sites

  • Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV

    Aguascalientes, 20230

  • Hospital Cardiologica Aguascalientes

    Aguascalientes, 20230

  • Mentrials SA DE CV

    Cuauhtémoc, Mexico City, 06700

  • Centro de Investigación y Atención de Diabetes - Endocrinología y Nutrición

    Durango, Guillermina, 34270

  • Dioderm Instituto de Investigacion

    Durango, 34060

  • Unidad de Investigacion Clinica Cardiometabolica de Occidente, S.C.

    Guadalajara, Jalisco, 44150

  • Consultorio Medico

    Guadalajara, Jalisco, C.P. 44210

  • Unidad de Investigación Clínica en Medicina S.C.

    Guadalajara, Jalisco, C.P. 44670

  • Centro de Desarrollo Biomédico S.C.P

    Mérida, Yucatán, 97070

  • Centro de Atención e Investigación en Factores de Riesgo Car

    México, Mexico DF, 14000

  • Clinicos Asociados BOCM SC

    Mexico City, Mexico City, 03300

  • Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology

    Mexico City, Mexico City, 11650

  • Sociedad de Metabolismo y Corazon, S.C.

    Veracruz, 91900

Other trials in Mexico

Colombia11 sites

  • Centro Cardiovascular y de Diabetes

    Barranquilla, Atlántico, 080020

  • Fundacion BIOS

    Barranquilla, Atlántico, 080020

  • Medplus Medicina Prepagada

    Bogotá, Bogota D.C., 110221

  • Endocare Ltda.

    Bogotá, Cundinamarca, 111111

  • Centro Medico Imbanaco de Cali S.A.

    Cali, Valle del Cauca Department, 760001

  • IPS Centro Medico Julian Coronel S.A

    Cali, Valle del Cauca Department, 760035

  • Rodrigo Botero S.A.S.

    Medellín, Antioquia, 050030

  • Centro Cardiovascular Colombiano Clínica Santa María

    Medellín, Antioquia, 050034

  • Fundacion Centro de Investigaciones Clinicas CARDIOMET

    Pereira, Risaralda Department, 660002

  • Asociación Colombiana de Diabetes

    Teusaquillo, Bogota D.C., 111311

  • Healthy Medical Center

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Russia11 sites

  • Kazan State Medical University

    Kazan', 420100

  • FSBI National medical endocrinology research centre

    Moscow, 117036

  • Moscow Regional Research Clinical Institute named by MF Vladimirski

    Moscow, 129110

  • Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko

    Nizhny Novgorod, Volga, 603126

  • Scientific Institute of Clinical and Experimental Lymphology

    Novosibirsk, Novosibirsk Oblast, 630117

  • Rostov on Don

    Rostov-on-Don, 344019

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • North-Western State Medical University named after I. I. Mechnikov

    Saint Petersburg, Sankt-Peterburg, 191015

  • GUZ Saratov City Clinical Hospital 9

    Saratov, 410030

  • Saratov City Clinical Hospital 12

    Saratov, 410039

  • Saint-Petersburg City Pokrovskaya Hospital

    St-Petersburg, Leningradskaya Oblast', 199106

Other trials in Russia

Brazil10 sites

  • Hospital Universitário João de Barros Barreto

    Belém, 66073-000

  • Centro de Pesquisa Clinica do Brasil

    Brasília, Federal District, 71625175

  • Scentryphar Pesquisa Clinica Ltda

    Campinas, São Paulo, 13020-431

  • Instituto de Pesquisa Clinica de Campinas

    Campinas, São Paulo, 13060904

  • Instituto de Estudos e Pesquisas Clinicas do Ceará IEP/CE - Oncology

    Fortaleza, Ceará, 60160-230

  • Hospital Universitário Walter Cantídio

    Fortaleza, Ceará, 60430-370

  • Instituto Catarinense de Endocrinologia e Diabetes (ICED)

    Joinville, Santa Catarina, 89201-260

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90430-001

  • CPQuali Pesquisa Clinica Ltda

    Santa Cecília, São Paulo, 01228-000

  • IPEC-Instituto de Pesquisa Clinica

    São Paulo, 01223-001

Other trials in Brazil

United Kingdom10 sites

  • MAC Research

    Barnsley, S75 3DL

  • MAC Clinical Research, Kaman Court

    Blackpool, FY2 0JH

  • MAC Research, Exchange House

    Cannock, Staffordshire, WS11 0BH

  • Mid Essex Hospital Services NHS Trust Broomfield Hospital

    Chelmsford, CM1 7ET

  • MAC Clinical Research, Monarch House

    Leeds, West Yorkshire, LS10 1DU

  • MAC Clinical Research

    Liverpool, L34 1BH

  • MAC Clinical Research Manchester

    Manchester, Greater Manchester, M13 9NQ

  • Biomedical Research Centre

    Nottingham, East Midland, NG7 2UH

  • Royal Oldham Hospital

    Oldham, Lancashire, OL1 2JH

  • MAC Clinical Research, GAC House

    Stockton-on-Tees, TS17 6EW

Other trials in United Kingdom

Argentina9 sites

  • CIPREC

    Buenos Aires, 1119

  • Maffei Centro Medico-Investigacion Clinica Aplicada

    C.a.b.a., Buenos Aires, C1425AGC

  • Hospital Sirio Libanes

    CABA, Buenos Aires, C1419AHN

  • Instituto Privado de Investigaciones Clínicas de Córdoba

    Córdoba, Córdoba Province, X5000AAW

  • Centro Universitario de Investigacion en Farmacologia Clinic

    Corrientes, W3410AVV

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600FYK

  • Instituto de Investigaciones Clinicas de Rosario

    Rosario, Santa Fe Province, 2000

  • Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli

    Rosario, Santa Fe Province, S200CFK

  • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Canada8 sites

  • South Shore Medical Arts

    Bridgewater, Nova Scotia, B4V 2V6

  • University of Calgary

    Calgary, Alberta, T2N 2T9

  • Alberta Diabetes Institute

    Edmonton, Alberta, T6G 2E1

  • Recherche GCP Research

    Montreal, Quebec, H1M 1B1

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 7W9

  • Central Alberta Research Centre

    Red Deer, Alberta, T4N 6V7

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Toronto Digestive Disease Associates

    Vaughan, Ontario, L4L 4YZ

Other trials in Canada

Philippines7 sites

  • Perpetual Succor Hospital

    Cebu City, 6000

  • West Visayas State University Medical Center

    Iloilo City, IloIlo, 5000

  • Ospital ng Makati

    Makati City, NCR, 1218

  • Manila Doctors Hospital, Ermita

    Manila, Metropolitan Manila, 1000

  • San Juan De Dios Educational Foundation, Inc.

    Pasay, Metropolitan Manila, 1300

  • St. Luke's Medical Center

    Quezon City, National Capital Region, 1100

  • Cardinal Santos Medical Center

    San Juan City, National Capital Region, 1502

Other trials in Philippines

Germany6 sites

  • Studienzentrum Schwittay

    Böhlen, Saxony, 4564

  • Klinische Forschung Dresden GmbH

    Dresden, Saxony, 1309

  • Clinical Research Hamburg

    Hamburg, 22143

  • Israelitisches Krankenhaus

    Hamburg, 22297

  • KRH Klinikum Siloah

    Hanover, 30459

  • Klinische Forschung Karlsruhe GmbH

    Karlsruhe, Baden-Wurttemberg, 76137

Other trials in Germany

Hungary6 sites

  • Synexus Budapest DRS

    Budapest, 1036

  • Strázsahegy Gyógyszertár Medicina

    Budapest, H1171

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, Heves County, H-3300

  • First Department of Medicine, University of Szeged

    Szeged, Csonfrád, 6720

  • Hetenyi Geza Hospital

    Tószeg, Jász-Nagykun-Szolnok, H-5004

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, Zala County, H-8900

Other trials in Hungary

Poland5 sites

  • NZOZ Vita Diabetica - Malgorzata Buraczyk

    Bialystok, Podlaski, 15-798

  • Centrum Medyczne Lukamed

    Chojnice, 89-600

  • Specjalistyczny Gabinet Neurologiczny Marta Banach

    Krakow, 30-539

  • Endoskopia Sp. Z O.O.

    Sopot, Pomeranian Voivodeship, 81-756

  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

    Wroclaw, 51-162

Other trials in Poland

South Africa5 sites

  • FARMOVS

    Bloemfontein, Free State, 9301

  • Synexus Helderberg Clinical Research Centre

    Cape Town, Western Cape, 7130

  • Wits Clinical Research

    Johannesburg, Gauteng, 2193

  • Synexus Stanza Clincal Reaserch Centre

    Pretoria, Gauteng, 0122

  • Watermeyer Clinical Research Site

    Pretoria, Gauteng, 0184

Other trials in South Africa

Austria4 sites

  • VIVIT Institute, am LKH Feldkirch

    Feldkirch, Vorarlberg, 6807

  • Privatklinik Wehrle-Diakonissen

    Salzburg, 5020

  • Ordination

    Sankt Stefan ob Stainz, Styria, 8511

  • Landeskrankenhaus Steyr

    Steyr, 4400

Other trials in Austria

Latvia4 sites

  • Polana-D

    Daugavpils, LV5401

  • Kraslava Hospital

    Krāslava, Kraslavas Nov., 5601

  • Pauls Stradins Clinical University Hospital, Endokrinologijas nodala

    Riga, 1002

  • Digestive Diseases Centre GASTRO

    Riga, 1006

Other trials in Latvia

Australia3 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Belgium3 sites

  • AZ Sint Lucas Brugge

    Bruges, West-Vlaanderen, 8310

  • Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,

    Edegem, Antwerp, 2650

  • UZ Brussel

    Jette, Brussels Capital, 1090

Other trials in Belgium

Malaysia3 sites

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah, 5460

  • Universiti Sains Malaysia

    Kubang Kerian, 16150

  • Hospital Taiping

    Taiping, 34000

Other trials in Malaysia

Singapore3 sites

  • National University Hospital

    Singapore, 119228

  • Singapore General Hospital

    Singapore, 169856

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

South Korea3 sites

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do, 561-712

  • Diabetes Center

    Seoul, Nowon-gu, 01757

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Thailand3 sites

  • Phramongkutklao Hospital

    Bangkok, 10400

  • Faculty of Medicine, Siriraj Hospital, Mahidol University

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

Other trials in Thailand

Bulgaria2 sites

  • MHAT Yuliya Vrevska Byala

    Byala, Ruse, 7100

  • UMHAT - Kaspela- EOOD

    Plovdiv, 4002

Other trials in Bulgaria

Denmark2 sites

  • Gentofte Hospital

    Hellerup, Copenhagen, 2900

  • Gastroenheden, Hvidovre hospital

    Hvidovre, Copenhagen, 2650

Other trials in Denmark

Israel2 sites

  • Bnai Zion Medical Center

    Haifa, 31048

  • Endocrinology & Diabetes Center

    Safed, 13100

Other trials in Israel

About this study

Official title: 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.

Being tested
Placebo, Relamorelin
Keywords
diabetic gastroparesis, vomiting
Medical subject headings
Gastroparesis, Diabetes Mellitus, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo injected twice daily

  • RelamorelinDrug

    Relamorelin 10 μg injected twice daily

Study groups in NCT03420781
Study groupRoleWhat they receive
Treatment Period: PlaceboPlacebo comparatorPlacebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.
Receives: Drug: Placebo
Treatment Period: Relamorelin 10 μgExperimentalRelamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.
Receives: Drug: Relamorelin
Randomized Withdrawal Period: Placebo then Relamorelin 10 μgExperimentalParticipants 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.
Receives: Drug: Placebo; Drug: Relamorelin
Randomized Withdrawal Period: Relamorelin 10 μg then Relamorelin 10 μgExperimentalParticipants 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.
Receives: Drug: Relamorelin
Randomized Withdrawal Period: Relamorelin 10 μg then PlaceboExperimentalParticipants 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.
Receives: Drug: Placebo; Drug: Relamorelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period

    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.

    Measured: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study

  2. Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period

    The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period.

    Measured: Week 6 to Week 12

Secondary outcomes (15)

  1. Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period

    A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 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.

    Measured: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)

  2. 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

    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.

    Measured: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)

  3. Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period

    A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 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.

    Measured: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)

  4. 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

    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.

    Measured: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)

  5. Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period

    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.

    Measured: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)

  6. Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period

    The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during the last 4 weeks of the 40-week Treatment Period.

    Measured: Week 37 to Week 40

  7. Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period

    The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. 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.

    Measured: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)

  8. Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period

    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.

    Measured: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)

  9. Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period

    The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. 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.

    Measured: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)

  10. Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.

    Measured: First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks)

  11. Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results

    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.

    Measured: Up to 46 weeks

  12. Number of Participants With Clinically Meaningful Trends for Vital Signs

    Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the results were clinically significant.

    Measured: Up to 46 weeks

  13. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results

    A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

    Measured: Up to 46 weeks

  14. Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)

    Measured: Up to 46 weeks

  15. Number of Participants With Anti-relamorelin Antibody Testing Results

    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.

    Measured: Up to 46 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2018
  2. Study start24 Jan 2018
  3. Primary completion30 Oct 2020
  4. Study completion30 Oct 2020

Why it stopped: The Relamorelin program is being terminated solely based on a business decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
467 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03420781
Sponsor's protocol ID
RLM-MD-03
Status last verified
Nov 2021
First submitted
24 Jan 2018
Last updated
22 Dec 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Relamorelin in people with Gastroparesis and Diabetes Mellitus, run by Allergan at 337 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 337 sites in United States, Ukraine, India, Mexico, Colombia and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03420781.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.

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