AzTrials
AzTrials

GastroparesisPhase 3NCT03383146

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

A Phase 3 study testing Relamorelin in people with Gastroparesis and Diabetes Mellitus, run by Allergan at 349 sites in 27 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 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis. 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
450 participants
Where
349 sitesin 27 countries
Study dates
1 Feb 2018to 5 Nov 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

  • Two different groups of participants may enter into the study:
  • Rollover Participants
  • Participants who were not randomization-eligible at the end of the Run-in Period of lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be randomized in the study if all of the following criteria apply:
  • •In the lead-in studies, participants must have met all screening visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary (DGSSD)) except that:
  • They had zero vomiting episodes and an average daily Diabetic Gastroparesis Symptom Severity Score (DGSSS) of ≥12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device; OR
  • They had vomiting episodes and an average daily DGSSS of ≥12 but <16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device
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  • De Novo Participants
  • Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) of at least 5 years' duration, with controlled and stable blood glucose levels and hemoglobin A1c (HBA1c) ≤11%
  • DG defined as at least a 3-month history prior to Screening of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of gastroparesis (GP) (e.g., nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety)
  • Compliance with the entry of data into the hand-held electronic device during the Run-in Period
  • Compliance with administration of subcutaneous (SC) twice daily injections during the Run-in Period
  • The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12

Who cannot join

  • Both Rollover and De Novo Participants
  • •Participants with a known allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)
  • Rollover Participants
  • •Participants will be excluded from this study if any of the lead-in study exclusion criteria apply at the Screening Visit and at the end of the Run-in Period for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria
  • De Novo Participants
  • History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of the Screening Visit
Show all 18Show fewer
  • History of intestinal malabsorption or pancreatic exocrine insufficiency
  • History of belching disorders, other nausea and vomiting disorders
  • Gastric or duodenal ulcer within 3 months of Screening
  • History of malignancy in the 3 years prior to Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression
  • Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (e.g., erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI promotility agents for at least 10 days prior to the start of the Run-in Period
  • Currently taking opiates, or expecting to use opiates during the course of the clinical study
  • Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period
  • History of pyloric injection of botulinum toxin within 6 months of screening
  • History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)
  • Randomization in any previous study in which relamorelin was a treatment
  • Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the gastric emptying breath test (GEBT) study meal

Trial locations and contacts

349 sites in 27 countries.

349 sites in 27 countries

United States183 sites

  • Synexus Clinical Research US, Inc.

    Akron, Ohio, 44311

  • 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

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • 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

  • DiscoveResearch, Inc.

    Beaumont, Texas, 77701

  • Dayton Gastroenterology,Inc.

    Beavercreek, Ohio, 45440

  • Simon Williamson Clinic

    Birmingham, Alabama, 35211

  • River Birch Research Alliance, LLC

    Blue Ridge, Georgia, 30513

  • WK Physicians Network

    Bossier City, Louisiana, 71111

  • Garden State Endocrinology LLC

    Brick, New Jersey, 08723

  • Gastroenterology Associates of Fairfield County, P.C.

    Bridgeport, Connecticut, 06606

  • Synexus Clinical Research US, Inc.

    Bridgeton, New Jersey, 08302

  • 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

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7080

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Carolinas Healthcare-Charlotte

    Charlotte, North Carolina, 28204

  • Clinsearch

    Chattanooga, Tennessee, 37421

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan, 48047

  • Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • GW Research Inc

    Chula Vista, California, 91910

  • Synexus Clinical Research US - Cincinnati

    Cincinnati, Ohio, 45236

  • Synexus Clinical Research US, Inc

    Cincinnati, Ohio, 45249

  • Innovative Research of West FL, Inc.

    Clearwater, Florida, 33756

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • Carolina Medical Research

    Clinton, South Carolina, 29325

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Synexus

    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

  • MNGI Digestive Health

    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

  • Avant Research Associates LLC

    Crowley, Louisiana, 70526

  • Top Medical Research

    Cutler Bay, Florida, 33189

  • 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

  • TriWest Research Associates

    El Cajon, California, 92020

  • Diagnamics Inc.

    Encinitas, California, 92024

  • St. Elizabeth Healthcare â€" Clinical Research Institute

    Erlanger, Kentucky, 41018

  • North Shore University Health System

    Evanston, Illinois, 60201

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Synexus Clinical Research US, Inc.

    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

  • Gastroenterology Centers of the Midsouth

    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

  • Synexus Clinical Research

    Greer, South Carolina, 29650

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • National Clinical, LLC

    Hamtramck, Michigan, 48212

  • Palmetto Research, LLC

    Hialeah, Florida, 33016

  • Vida Clinical Trials

    Homestead, Florida, 33030

  • Cronola LLC

    Houma, Louisiana, 70360

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030

  • Biopharma Informatic Inc., Research Center

    Houston, Texas, 77043

  • Houston Endoscopy and Research Center, Inc.

    Houston, Texas, 77079

  • Rodriguez Clinical Trials

    Houston, Texas, 77083

  • Amir Hassan, MD, PA

    Houston, Texas, 77089

  • Avant Research Associates

    Huntsville, Alabama, 35801

  • 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

  • American Research, LLC

    Jeffersonville, Indiana, 47130

  • United Health Services Hospitals, Inc.

    Johnson City, New York, 13790

  • East Tennessee Research Institute

    Johnson City, Tennessee, 37604

  • 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 - CROSN

    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, 89135

  • Synexus Clinical Research US, Inc.

    Layton, Utah, 84041

  • 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, 90057

  • University of Louisville

    Louisville, Kentucky, 40202

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Manassas Clinical Research Centre

    Manassas, Virginia, 20110

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • 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

  • 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

  • Synexus Clinical Research US, Inc.

    Murray, Utah, 84123

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Quality Medical Research

    Nashville, Tennessee, 37211

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453

  • Sensible Healthcare

    Ocoee, Florida, 34761

  • Advanced Research Institute, Inc.

    Ogden, Utah, 84405

  • Centennial Health-Synexus

    Oklahoma City, Oklahoma, 73111

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma, 73112

  • Memorial Clinical Research

    Oklahoma City, Oklahoma, 73120

  • Diabetes and Endocrine Associates, P.C.

    Omaha, Nebraska, 68114

  • Heartland Clinical Research, Inc

    Omaha, Nebraska, 68134

  • Stanford Hospital

    Palo Alto, California, 94304

  • 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

  • Health Science Research Center

    Pratt, Kansas, 67124

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Synexus Clinical Research US, Inc.

    Richfield, Minnesota, 55423

  • VA Medical Center McGuire VAMC

    Richmond, Virginia, 23249

  • 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

  • Sagact Pllc.

    San Antonio, Texas, 78229

  • Synexus Clinical Research US, Inc.

    San Antonio, Texas, 78229

  • Optimal Research California

    San Diego, California, 92108

  • Medical Associates Research Group, Inc

    San Diego, California, 92123

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Guthrie Clinical Research

    Sayre, Pennsylvania, 18840

  • Frontier Clinical Research, LLC

    Scottdale, Pennsylvania, 15683

  • Unity Health - Searcy Medical Center

    Searcy, Arkansas, 72143

  • WestGlen Gastrointestinal Consultants

    Shawnee Mission, Kansas, 66217

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478

  • Synexus Clinical Research US, Inc

    St Louis, Missouri, 63141

  • Clinical Research Consultants of Atlanta

    Suwanee, Georgia, 30024

  • Washington Gastroenterology PLLC

    Tacoma, Washington, 98405

  • CHEAR Center LLC

    The Bronx, New York, 10455

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

    Topeka, Kansas, 66606

  • Kansas Medical Clinic

    Topeka, Kansas, 66606

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85710

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85712

  • Synexus Clinical Research US, Inc.

    Tucson, Arizona, 85741

  • Options Health Research, LLC

    Tulsa, Oklahoma, 74104

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Upland Clinical Research

    Upland, California, 91786

  • Synexus Clinical Research US, Inc.

    Vista, California, 92083

  • Family Practice Center of Wadsworth, Inc.

    Wadsworth, Ohio, 44281

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Clinical Trials of America, Inc.

    West Monroe, Louisiana, 71291

  • New Hope Research Development

    Whittier, California, 90603

  • 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

  • Gastroenterology Associates of Western Michigan, West Michigan Clinical Research Center

    Wyoming, Michigan, 49519

Other trials in United States

India22 sites

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

    Ahmedabad, Gujarat, 380007

  • Zydus Hospital

    Ahmedabad, Gujarat, 380054

  • Lifecare Clinic and Research Centre - Internal Med/Diabetology

    Bangalore, Karnataka, 560092

  • Diacon Hospital and research Center - Diabetology

    Bengaluru, Karnataka, 359-360

  • Victoria Hospital Bangalore Medical College and Research Institute

    Bengaluru, Karnataka, 560002

  • Rajalakshmi Hospital

    Bengaluru, Karnataka, 560097

  • M.V. Hospital for Diabetes & Diabetes Research Centre

    Chennai, Tamil Nadu, 600013

  • Kovai Diabetes Speciality Centre

    Coimbatore, Tamil Nadu, 641009

  • Sir Ganga Ram Hospital (SGRH)

    Delhi, 110060

  • Kumudini Devi Diabetes Research Center; Ramdevrao Hospital

    Hyderabad, Andhra Pradesh, 500072

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

    Jaipur, Rajasthan, 302001

  • Marudhar Hospital

    Jaipur, Rajasthan, 302012

  • Eternal Hospital - Diabetology

    Jaipur, Rajasthan, 302017

  • SMS Hospital

    Jaipur, Rajasthan, 302017

  • M V Hospital & Research Centre

    Lucknow, Uttar Pradesh, 226003

  • Arthur Asirvatham Hospital

    Madurai, Tamil Nadu, 625020

  • Vinaya Hospital & Research Centre

    Mangalore, 575003

  • Bhatia Hospital

    Mumbai, Maharashtra, 400007

  • 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

Ukraine16 sites

  • Chernivtsi Regional Clinical Hospital

    Chernivtsi, 58001

  • Regional Municipal noncommercial Enterprise "Chernivtsi Regional Endocrinology Center", Polyclinic department, Higher State Educational Establishment of Ukraine "Bukovinian State Medical University", Department of Clinical Immunology, Allergology and Endo

    Chernivtsi, 58022

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

    Dnipro, Dnipropetrovsk Oblast, 49027

  • Ivano-Frankivsk National Medical University

    Ivano-Frankivsk, 76008

  • Ivano-Frankivsk Central City Clinical Hospital

    Ivano-Frankivsk, 76018

  • Municipal nonprofit entity of Kharkiv municipal council

    Kharkiv, 61037

  • 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

  • Kyiv Railway Clinical Hospital No-2 of Branch of Healthcare Center of the PJSC Ukrainian Railway , Endocrynology Department

    Kyiv, 3049

  • 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

  • Poltava Regional Clinical Hospital

    Poltava, 36011

  • Private Small-Scale Enterprise Medical Centre Pulse

    Vinnytsia, 21001

  • Vinnytsia Regional Clinical highly specialized Endocrinology Centre

    Vinnytsia, 21010

  • Municipal Institution, City Hospital #7, polyclinic department, c. Zaporizhzhia

    Zaporizhzhya, Zaporizhzhia Oblast, 69600

  • Municipal Institution 6th City Clinical Hospital, Dept of Gastroenterology

    Zaporizhzhya, 69035

Other trials in Ukraine

Mexico13 sites

  • Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV

    Aguascalientes, 20230

  • Hospital Cardiologica Aguascalientes

    Aguascalientes, 20230

  • Dioderm Instituto de Investigacion

    Durango, 34060

  • CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)

    Durango, 34270

  • Unidad de Investigacion Clinica Cardiometabolica de Occidente

    Guadalajara, Jalisco, 44150

  • Consultorio particular

    Guadalajara, Jalisco, 44210

  • Unidad de Investigación Clínica en Medicina S.C/

    Guadalajara, Jalisco, 44670

  • Centro de Desarrollo Biomédico S.C.P

    Mérida, Yucatán, 97070

  • Clinicos Asociados BOCM SC

    Mexico City, Mexico City, 03300

  • Mentrials Sa de Cv

    Mexico City, Mexico City, 06700

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

    Mexico City, Mexico City, 11650

  • Centro de Atención e Investigación en Factores de Riesgo Car

    Mexico City, Mexico City, 14000

  • Sociedad de Metabolismo y Corazon S.C.

    Veracruz, 91900

Other trials in Mexico

Colombia11 sites

  • Centro Cardiovascular y de Diabetes

    Barranquilla, Atlántico, 080020

  • Fundación del Caribe para la InvestigacionBiomédica-Fundación BIOS

    Barranquilla, Atlántico, 080020

  • Medplus Centro de Recuperacion Integral S.A.S.

    Bogotá, Bogota D.C., 110221

  • Endocare Ltda.

    Bogotá, Bogota D.C., 111111

  • Asociación Colombiana de Diabetes

    Bogotá, Cundinamarca, 111311

  • IPS Centro Medico Julian Coronel S.A

    Cali, Valle del Cauca Department, 760035

  • Centro Medico Imbanaco de Cali S.A.

    Cali, Valle del Cauca Department, 760042

  • Rodrigo Botero S.A.S.

    Medellín, Antioquia, 050030

  • Centro Cardiovascular Colombiano Clínica Santa María

    Medellín, Antioquia, 050034

  • Centro de Investigaciones Clínicas IPS CARDIOMET Pereira

    Pereira, Risaralda Department, 660003

  • Healthy Medical Center

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

United Kingdom11 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, Merseyside, L34 1BH

  • MAC Clinical Research Manchester

    Manchester, Greater Manchester, M13 9NQ

  • MAC Clinical Research, GAC House

    Manchester, M13 9NQ

  • Biomedical Research Centre

    Nottingham, East Midland, NG7 2UH

  • Royal Oldham Hospital

    Oldham, Lancashire, OL1 2JH

  • University Hospitals of North Midlands

    Stoke-on-Trent, Staffordshire, ST6 8DG

Other trials in United Kingdom

Argentina10 sites

  • Consultorios Asociados de Endocrinologia e Investigación Cl

    Buenos Aires, Buenos Aires, C1425AGC

  • CIPREC

    Buenos Aires, Ciudad Autonoma deBuenos Aires, 1119

  • Hospital Sirio Libanes

    CABA, Buenos Aires, C1419AHN

  • Instituto Privado de Investigaciones Clinicas de Cordoba

    Córdoba, X5000AAW

  • CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian

    Córdoba, X5000BNB

  • Centro Universitario de Investigacion en Farmacologia Clinic

    Corrientes, W3410AVV

  • Centro de Investigaciones Medicas Mar del Plata SRL

    Mar del Plata, Buenos Aires, B7600FYK

  • Instituto de Investigaciones Clinicas de Rosario

    Rosario, Santa Fe Province, S2000BIE

  • Instituto Medico Catamarca-I.ME.C

    Rosario, Santa Fe Province, S200CFK

  • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Brazil10 sites

  • Hospital Universitário João de Barros Barreto - UFPA

    Belém, Pará, 66073-005

  • Centro de Pesquisa Clinica do Brasil

    Brasília, Federal District, 71625175

  • Scentryphar Pesquisa Clínica Ltda

    Campinas, São Paulo, 13020-431

  • Instituto de Pesquisa Clinica em Campinas

    Campinas, São Paulo, 13060-080

  • Hospital Universitário Walter Cantídio

    Fortaleza, Ceará, 60430-270

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

    Fortaleza, 60160-230

  • 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

  • IPEC-Instituto de Pesquisa Clinica

    São Paulo, 01223-001

  • CPQuali Pesquisa Clinica Ltda

    São Paulo, 01228-000

Other trials in Brazil

Canada8 sites

  • South Shore Medical Arts

    Bridgewater, Nova Scotia, B4V 3N2

  • University of Calgary

    Calgary, Alberta, T2N 2T9

  • Recherche GCP Research

    Montreal, Quebec, H1M 1B1

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 7W9

  • Central Alberta Research Centre

    Red Deer, Alberta, T4N 6V7

  • Patient research centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Toronto Digestive Disease Associates, Inc.

    Vaughan, Ontario, L4L 4Y7

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, 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, 76199

Other trials in Germany

Hungary5 sites

  • Strázsahegy Gyógyszertár Medicina

    Budapest, H1171

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, Heves County, H-3300

  • Szegedi TudomanyegyetemSzent-Gyorgyi Albert Klinikai Kozpont és Altalanos Orvostudomanyi Kar Belgyogyaszati Klinika

    Szeged, H-6720

  • Hetenyi Geza Hospital

    Szolnok, Jász-Nagykun-Szolnok, H-5004

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, Zala County, H-8900

Other trials in Hungary

South Africa5 sites

  • FARMOVS

    Bloemfontein, Free State, 9301

  • Wits Clinical Research

    Johannesburg, Gauteng, 2193

  • Synexus Stanza Clinical Research Centre

    Pretoria, Gauteng, 0122

  • Watermeyer Clinical Research Site

    Pretoria, Val de Grace, 0184

  • Synexus Helderberg Clinical Research Centre

    Somerset West, 7130

Other trials in South Africa

Austria4 sites

  • VIVIT Institute, am LKH Feldkirch

    Feldkirch, Vorarlberg, 6807

  • Ordination

    Osterreicher, Styria, 8511

  • Privatklinik wehlre-Diakonissen

    Salzburg, 5020

  • Oö. Gesundheits- und Spitals-AG/LKH Steyr

    Steyr, 4400

Other trials in Austria

Bulgaria4 sites

  • MHAT Yuliya Vrevska Byala

    Byala, Ruse, 7100

  • UMHAT - Kaspela- EOOD

    Plovdiv, 4002

  • Medical Center Asklepion - Humane Medicine Research EOOD

    Sofia, 1303

  • Alexandrovska University Hospital

    Sofia, 1431

Other trials in Bulgaria

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

Malaysia4 sites

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah, 5460

  • Clinical Investigation Centre

    Kuala Lumpur, 59100

  • Clinical Trial Unit, School of Medical Sciences, Health Campus, Hospital Universiti Sains Malaysia

    Kubang Kerian, 16150

  • Hospital Taiping

    Taiping, 34000

Other trials in Malaysia

Russia4 sites

  • Scientific Institute of Clinical and Experimental Lymphology

    Novosibirsk, 630117

  • Rostov on Don

    Rostov-on-Don, 344019

  • GUZ Saratov City Clinical Hospital 9

    Saratov, Saratov Oblast, 410030

  • Saint-Petersburg City Pokrovskaya Hospital

    St-Petersburg, Leningradskaya Oblast', 199106

Other trials in Russia

Australia3 sites

  • Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated

    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

Poland3 sites

  • Centrum Medyczne Lukamed

    Chojnice, 89-600

  • Specjalistyczny Gabinet Neurologiczny Marta Banach

    Krakow, Lesser Poland Voivodeship, 30-539

  • CenterMed Krakow Ltd

    Krakow, Malopolska, 31-530

Other trials in Poland

Singapore3 sites

  • National University Hospital

    Singapore, 119228

  • Changi General Hospital

    Singapore, 529889

  • Singapore General Hospital

    Singapore, S169856

Other trials in Singapore

South Korea3 sites

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do, 561-712

  • Sanggye Paik Hospital, Inje University College of Medicine

    Seoul, Nowon-gu, 1757

  • 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

Denmark2 sites

  • Steno Diabetes Center Copenhagen

    Hellerup, Copenhagen, 2900

  • Gastroenheden, Hvidovre hospital

    Hvidovre, København, 2605

Other trials in Denmark

Israel1 site

  • Bnei-Zion MC

    Haifa, 31948

Other trials in Israel

Spain1 site

  • Hospital Universitario Principe de Asturias

    Madrid, 28850

Other trials in Spain

About this study

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

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

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 subcutaneously twice daily.

  • RelamorelinDrug

    Relamorelin 10 μg injected subcutaneously twice daily.

Study groups in NCT03383146
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Receives: Drug: Placebo
Relamorelin 10 μgExperimentalRelamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Receives: 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)

    Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.

    Measured: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study

  2. Change From Baseline to Week 52 in the Weekly Average DGSSS

    Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.

    Measured: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study

  3. 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 56 weeks)

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

    Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 participant had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

    Measured: Up to 52 weeks

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

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

    Measured: Up to 52 weeks

  6. 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 52 weeks

  7. Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c)

    Measured: Up to 52 weeks

  8. Number of Participants With Anti-relamorelin Antibody Testing Results by Visit

    A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.

    Measured: Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364)

Timeline

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

  1. First posted26 Dec 2017
  2. Study start1 Feb 2018
  3. Primary completion5 Nov 2020
  4. Study completion5 Nov 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
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03383146
Sponsor's protocol ID
RLM-MD-04
Other IDs
2017-002144-33, 2017
Status last verified
Nov 2021
First submitted
19 Dec 2017
Last updated
23 Nov 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 349 sites in 27 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 12 inclusion and 18 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 349 sites in United States, India, Ukraine, Mexico, Colombia and 22 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 23 Nov 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) (time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study). The study lists 8 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 NCT03383146.

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 23 Nov 2021.

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