GastroparesisPhase 3NCT03786380
Diabetic Gastroparesis Study 05
A Phase 3 study testing Relamorelin 10 μg in people with Gastroparesis, run by Allergan at 486 sites in 30 countries.
Trial summary
This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Relamorelin 10 μg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 486 sitesin 30 countries
- Study dates
- 20 Dec 2018to 5 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
- Successful completion of either Study RLM-MD-03 or Study RLM-MD-04
- Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures
- Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator.
Who cannot join
- Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020
- Participant has an unresolved adverse event (AE) from a lead-in study, ie, 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
- Females who are pregnant, nursing, or planning a pregnancy during the study.
Trial locations and contacts
486 sites in 30 countries.
486 sites in 30 countries
United States189 sites
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87108
HCP Clinical Research LLC
Anaheim, California, 92801
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
Emory University
Atlanta, Georgia, 30322
University of Colorado, Denver
Aurora, Colorado, 80045
Avant Research Associates,LLC
Austin, Texas, 78704
Visionary Investigators Network
Aventura, Florida, 33180
Delta Research Partners
Bastrop, Louisiana, 71220
DiscoveResearch, Inc.
Beaumont, Texas, 77701
Dayton Gastroenterology,Inc.
Beavercreek, Ohio, 45440
University of Alabama at Birmingham
Birmingham, Alabama, 35295
River Birch Research Alliance, LLC
Blue Ridge, Georgia, 30513
Test Center 3
Brick, New Jersey, 08723
Gastroenterology Associates of Fairfield County, P.C.
Bridgeport, Connecticut, 06606
Connecticut Clinical Research Foundation
Bristol, Connecticut, 06010
Commonwealth Clinical Studies, PLLC.
Brockton, Massachusetts, 02302
Gwinnett Research Institute
Buford, Georgia, 30519
Hope Clinical Research
Canoga Park, California, 91303
Summit Clinical Research, LLC.
Carnesville, Georgia, 30521
Biocon Clinical Research, LLC
Caro, Michigan, 48723
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
Test Center 2
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
Gastro Florida
Clearwater, Florida, 33756-3839
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Clinical Research of West Florida
Clearwater, Florida, 33765
The MetroHealth System MHS
Cleveland, Ohio, 44109-1998
Digestive Disease & Surgery Institute
Cleveland, Ohio, 44195
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
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
PMG Research of Charlotte, LLC
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
Tri-State Gastroenterology
Crestview Hills, Kentucky, 41017
Avant Research Associates LLC
Crowley, Louisiana, 70526
Partners in Clinical Research, LLC
Cumberland, Rhode Island, 02864
American Research Institute, Inc
Cutler Bay, Florida, 33157
Top Medical Research
Cutler Bay, Florida, 33189
Carolina Digestive Health Associates, PA
Davidson, North Carolina, 28036
Clinical Inquest Center Ltd.
Dayton, Ohio, 45409
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
Texas Tech University Health Sciences, Center Division of Gastroenterology
El Paso, Texas, 79905
Diagnamics Inc.
Encinitas, California, 92024
Denver Esophageal and Stomach Center
Englewood, Colorado, 80110
North Shore University Health System
Evanston, Illinois, 60201
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
Valley View Wellness and Medical Center - VVCRD Clinical Research
Garden Grove, California, 92845
DHAT Research Institute
Garland, Texas, 75044
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
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, 70630
Baylor College of Medicine Medical Center
Houston, Texas, 77030
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
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Nature Coast Clinical Research
Inverness, Florida, 34452
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
University of Florida
Jacksonville, Florida, 32207
Queens Hospital Center
Jamaica, New York, 11432
American Research, LLC
Jeffersonville, Indiana, 47130
United Health Services Hospitals, Inc.
Johnson City, New York, 13760
University of Kansas Medical Center
Kansas City, Kansas, 66160
Vidant Multispeciality Clinic - Kinston
Kinston, North Carolina, 28501
University of California San Diego
La Jolla, California, 92037
Centex Studies, Inc. - Lake Charles- Clinical Trials of SWLA, LLC
Lake Charles, Louisiana, 70601
Florida Research Institute
Lakewood Rch, Florida, 34211
Om Research LLC
Lancaster, California, 93534
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, 89135
Family Medical Associates, Research Department
Levittown, Pennsylvania, 19056
Preferred Clinical Research Partners
Little Rock, Arkansas, 72205
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Torrance Clinical Research Institute, Inc.
Lomita, California, 90717
Tibor Rubin VA Medical Center
Long Beach, California, 90822
Angel City Research Inc.
Los Angeles, California, 90057
University of Louisville
Louisville, Kentucky, 40202
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
Cfagi Llc
Maitland, Florida, 32751
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
Panax Clinical Research
Miami Lakes, Florida, 33014
Savin Medical Group LLC
Miami Lakes, Florida, 33014
NYU Winthrop Hospital, Clinical Trials Center
Mineola, New York, 11501
Facey Medical Foundation
Mission Hills, California, 91345
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
Gastroenterology Group of Naples
Naples, Florida, 34102
Quality Medical Research
Nashville, Tennessee, 37211
Weill Cornell Medical College
New York, New York, 10065
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
Henry Ford Health System
Novi, Michigan, 48377
Southwest Gastroenterology
Oak Lawn, Illinois, 60453
Sensible Healthcare
Ocoee, Florida, 34761
Advanced Research Institute, Inc.
Ogden, Utah, 84405
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73112
Memorial Clinical Research
Oklahoma City, Oklahoma, 73120
Heartland Clinical Research, Inc
Omaha, Nebraska, 68134
Stanford Hospital
Palo Alto, California, 94304
Gulf Region Clinical Research Institute
Pensacola, Florida, 32514
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Phoenix Clinical LLC.
Phoenix, Arizona, 85014
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, 15212
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15236
TriWest Research Associates
Poway, California, 92064
Health Science Research Center
Pratt, Kansas, 67124
Health Concepts
Rapid City, South Dakota, 57702
VA Medical Center McGuire VAMC
Richmond, Virginia, 23249
Infinite Clinical Trials
Riverdale, Georgia, 30274
Test Center 4
Roanoke, Virginia, 24014
PMG Research Salisbury
Salisbury, North Carolina, 28144
Test Center
Salt Lake City, Utah, 84124
Digestive Center of South Texas
San Antonio, Texas, 78215
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
SAGACT PLLC., San Antonio Gastroenterology Associates, PA
San Antonio, Texas, 78229
Clinical Applications Laboratories, Inc.
San Diego, California, 92103
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
Montgomery Medical, Inc.
Smithfield, Pennsylvania, 15478
Coastal Research Associates, Inc.
South Weymouth, Massachusetts, 02190
Texas Digestive Disease Consultants
Southlake, Texas, 76092
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Washington University in St. Louis
St Louis, Missouri, 63110
Washington Gastroenterology PLLC
Tacoma, Washington, 98405
University of South Florida
Tampa, Florida, 33606
Gastro Florida
Tampa, Florida, 33626
Cotton-O'Neil Clinical Research Center - Digestive Health
Topeka, Kansas, 66606
Troy Gastroenterology, PC dba Center for Digestive Health
Troy, Michigan, 48098
Adobe Clinical Research LLC
Tucson, Arizona, 85712
Del Sol Research Management, LLC
Tucson, Arizona, 85712
Options Health Research, LLC
Tulsa, Oklahoma, 74104
Preferred Primary Care Physicians, Jacob Murphy
Uniontown, Pennsylvania, 15401
Upland Clinical Research
Upland, California, 91786
Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research
Wadsworth, Ohio, 44281
Integrated Clinical Trial Services Inc
West Des Moines, Iowa, 50265
Advanced Clinical Research
West Jordan, Utah, 84088
Clinical Trials of America, Inc.
West Monroe, Louisiana, 71291
Boston VA Healthcare System
West Roxbury, Massachusetts, 02130
Cleveland Clinic Florida - Weston
Weston, Florida, 33331
New Hope Research Development
Whittier, California, 90603
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67205-1138
Via Christi Clinic, PA
Wichita, Kansas, 67208
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Cardinal Internal Medicine
Woodbridge, Virginia, 22192
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, 49519
Ukraine33 sites
Municipal nonprofit entity "Chernigiv city hospital #2" of Chernigiv municipal council, therapeutic department
Chernihiv, 14034
Regional 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 diseases, c.C
Chernivtsi, 58001
Regional Public Organization Chernivtsi Regional Endocrinology Center
Chernivtsi, 58022
State Institution Ukrainian State Research Institute
Dnipro, Dnipropetrovsk Oblast, 49027
SU Clinic of medical academy of SI Dnepropetrovsk medical cacadamy of MoH of Ukraine
Dnipro, 49038
"Kryvyi Rih City Hospital #3" of Dnipropetrovsk Regional Council
Dnipropetrovsk Region, Dnipropetrovsk Oblast, 50002
Ivano-Frankivsk National Medical University
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008
Ivano-Frankivsk Central City Clinical Hospital
Ivano-Frankivsk, 76018
Municipal nonprofit entity "City clinical hospital #2 n.a. Prof.O.O.Shalimov" of Kharkiv municipal council, department of endocrinology
Kharkiv, 61037
"State Institution "National Institute of Therapy named after. L.T. Maloi NAMNU" / Government Institution "L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine", Department of the study of diseases of the digestive
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
Kyiv city clinical endocrinology center, department of general endocrine pathology and metabolism, c. Kyiv
Kyiv, Kyïv, 1034
Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv
Kyiv, 2002
Kyiv Railway Clinical Hospital #2 of Branch Healthcare Center of the PJSC Ukranian Railway, Endocrynology Department
Kyiv, 3049
Medical Center Universal Clinic OberigMedical Center Universal Clinic Oberig / Medical Center "Universal Clininc "Oberig" of LLC "Capital", Gastroenterological Center, c. Kyiv
Kyiv, 3680
Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit
Kyiv, 4050
Institute of Endocrinology and Metabolism im. V. P. Komisarenka NAMS Ukraine
Kyiv, 4114
Municipal Institution Lutsk City Clinical Hospital
Lutsk, Volyos'ka Oblast', 43024
City Hospital #1, department of endocrinology, c. Mykolayiv
Mykolaiv, 54003
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
Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital
Sumy, 40031
Ternopil University Hospital, Regional Center for Gastroenterology with Hepatology, Department of Gastroenterology
Ternopil, 46000
DRRI-Vinnytsia National Pirogov Memorial Medical University
Vinnytsia, Vinnytsia Oblast, 21029
Private Small-Scale Enterprise Medical Center Pulse
Vinnytsia, 21001
Medical Center of the Limited Liability Company "Health Clinic", Medical Clinical Research Center, Department of Gastroenterology, Hepatology and Endocrinology
Vinnytsia, 21009/21029
Vinnytsia Regional Clinical highly specialized Endocrinology Centre
Vinnytsia, 21010
Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", gastroenterological department, Vinnytsia National Pirogov Memorial Medical University, department of propedeutics of internal medicine, c. Vinnytsia
Vinnytsia, 21029
6th City Clinical Hospital, c. Zaporizhzhia
Zaporizhzhya, 69035
"Municipal Institution ""City Hospital #7"", polyclinic department, c. Zaporizhzhia"
Zaporizhzhya, 69600
Municipal Institution-Zaporizhzhia Regional Clinical Hospital
Zaporizhzhya, 69600
India30 sites
Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Res
Ahmedabad, Gujarat, 380007
Zydus Hospital
Ahmedabad, Gujarat, 380054
Lifecare Clinic and Research Centre - Internal Med/Diabetolo
Bangalore, Karnataka, 560092
M. S. Ramaiah medical College and Hospitals - Gastroenterolo
Bangalore, 560054
Diacon Hospital and research Center
Bengaluru, Karnataka, 359-360
Victoria Hospital Bangalore Medical College and Research Ins
Bengaluru, Karnataka, 560002
Rajalakshmi Hospital
Bengaluru, Karnataka, 560097
S.P.Medical College & Group of Hospitals Bikaner
Bikaner, Rajasthan, 334003
Madras Medical College & Rajiv Gandhi Govt. General Hospital
Chennai, Tamil Nadu, 600003
M.V. Hospital for Diabetes & Diabetes Research Centre
Chennai, Tamil Nadu, 600013
Kovai Diabetes Speciality Centre
Coimbatore, Tamil Nadu, 641009
Gleneagles Global Hospital
Hyderabad, 500004
Kumudini Devi Diabetes Research Center
Hyderabad, 500072
S.R. Kalla Memorial Gastro and General Hospital
Jaipur, Rajasthan, 302001
Sawai Man Singh Hospital
Jaipur, Rajasthan, 302004
Sir Ganga Ram Hospital (SGRH)
Jaipur, Rajasthan, 302006
Marudhar Hospital
Jaipur, Rajasthan, 302012
Eternal Hospital, Unit of Eternal Heart Care Centre and Research Institute Pvt. Ltd.
Jaipur, Rajasthan, 302017
IPGME&R and SSKM Hospital
Kolkata, West Bengal, 700020
M V Hospital & Research Centre
Lucknow, Uttar Pradesh, 226003
Arthur Asirvatham Hospital
Madurai, Tamil Nadu, 625020
Vinaya Hospital & Research Centre
Mangalore, Karnataka, 575003
Bhatia Hospital
Mumbai, 400007
Chopda Medicare & Research Centre Pvt.Ltd, Magnum Heart Institute
Nashik, Maharashtra, 422005
B. J. Government Medical College and Sassoon General Hospitals
Pune, Maharashtra, 411001
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, 411001
University Hospital
Pune, Maharashtra, 411011
Noble Hospital
Pune, Maharashtra, 411013
Surat Institute of Digestive Sciences Hospitals
Surat, Gujarat, 395002
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002
Mexico20 sites
Practice Dr Gerardo Gonzalez
Acapulco, 39350
Hospital Cardiológica Aguascalientes
Aguascalientes, 20230
Centro Especializado en Investigación Clínica S.C.
Boca del Rio, Veracruz, 94290
Instituto de Diabetes Obesidad y Nutrición SC
Cuautla, Morelos, 62746
Dioderm Instituto de Investigación
Durango, 34060
CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)
Durango, 34270
Unidad de Investigación Clínica Cardiometabolica de Occidente
Guadalajara, Jalisco, 44150
Consultorio Medico
Guadalajara, Jalisco, 44210
Unidad de Investigación clínica y atención Médica HEPA S.C.
Guadalajara, Jalisco, 44670
Investigación Médica Sonora, S.C.
Hermosillo, Sonora, 83280
Centro de Investigacion Morales Vargas - CIMOVA
León, Guanajuato, 37000
Centro de Desarrollo Biomédico
Mérida, Yucatán, 97070
Clinicos Asociados BOCM SC
Mexico City, Mexico City, 03300
Clinica OMEGA
Mexico City, Mexico City, 14000
Instituto Nacional de Ciencias Medicas y Nutricion
Mexico City, Mexico City, 14080
Medical and Nutritional Trials
México DF, Mexico City, 6700
Accelerium Clinical Research
Monterrey, Nuevo León, 64000
Centro Medico Christus Muguerza Sur
Monterrey, Nuevo León, 64700
Centro de Diabetes de Pachuca
Pachuca, Hidalgo, 42090
Sociedad de Metabolismo y Corazón, S.C.
Veracruz, 91900
United Kingdom18 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
Western General Hospital Edinburgh
Edinburgh, EH4 2XU
MAC Clinical Research, Monarch House
Leeds, LS10 1DU
MAC Clinical Research
Liverpool, L34 1BH
Wingate Institute
London, E1 2AJ
University College London Hospita
London, NW1 2BU
MAC Clinical Research Manchester
Manchester, M13 9NQ
University Hospital of South Manchester
Manchester, M23 9LT
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
Biomedical Research Centre
Nottingham, NG7 2UH
Royal Oldham Hospital
Oldham, Lancashire, OL1 2JH
MAC Clinical Research, GAC House
Stockton-on-Tees, TS17 6EW
University Hospitals of North Midlands
Stoke-on-Trent, Staffordshire, ST6 8DG
St George's Hospital
Tooting, SW17 0QT
Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
Poland16 sites
NZOZ Vita - Diabetica Malgorzata Buraczyk, Diabetes Clinic,
Bialystok, Bia|ystok, 15-879
Szpital Uniwestytetu Medycznego w Bialymstoku
Bialystok, 15-276
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, 85-065
Vitamed
Bydgoszcz, 85-079
Centrum Medyczne Lukamed
Chojnice, 89-600
Silmedic Sp z o o
Katowice, 40 282
Specjalistyczny Gabinet Neurologiczny Marta Banach
Krakow, 30-539
CenterMed Krakow Ltd
Krakow, 31-530
Centrum Medyczne Medyk
Lublin, 20-090
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10-561
Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer sp. Z o.o.
Pruszków, 05-800
Endoskopia SP. Z O.O.
Sopot, 81-756
Centrum Medyczne Pratia Warszawa
Warsaw, Warazawa, 01-868
Powiatowe Centrum Medyczne w Wołowie
Wołów, 56-100
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroclaw, 51-162
Zamość
Zamość, PL 22-400
Canada15 sites
South Shore Medical Arts
Bridgewater, Nova Scotia, B4V 2V6
University of Calgary
Calgary, Alberta, T2N 4Z6
Alberta Diabetes Institute
Edmonton, Alberta, T6G 2E1
Dr. Anil K. Gupta Medicine Professional Corporation
Etobicoke, Ontario, M9V4B4
CISSS de la Monteregie-Centre
Greenfield Park, Quebec, J4V 2H1
Recherche GCP Research
Montreal, Quebec, H1M 1B1
Centre Hospitalier de l'Universite de Montreal - CHUM
Montreal, Quebec, H2X 0A9
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9
Central Alberta Research Centre
Red Deer, T4N 6V7
Eastern Health
St. John's, Newfoundland and Labrador, NL A1B 3V6
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
Toronto Digestive Disease Associates
Vaughan, L4L 4YZ
Italy15 sites
Ospedale Cardinal Massaia
Asti, 14100
University of Bari
Bari, 70121
Azienda Ospedaliera Rilievo Nazionale Alta Specialita (ARNAS) Garibaldi
Catania, 95122
Universita Magna Graecia di Catanzaro
Catanzaro, 88100
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova, 16132
Universita degli Studi di Napoli Federico II
Naples, 80131
Azienda Opsedaliera di Padova
Padova, 35128
IRCCS S.Matteo Hospital Foundation, University of Pavia
Pavia, 27100
University of Pisa - Cisanello Hospital
Pisa, 56126
Policlinico Gemelli, Divisione di Endocrinologia e Malattie del Metabolismo
Rome, Rome Roma, 168
Gruppo Humanitas - Humanitas Research Hospital
Rozzano, 20089
Universita' Di Salerno- Aou Ruggi D'aragona
Salerno, 80100
IRCCS Policlinico San Donato
San Donato Milanese, Milan, 20097
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
Clinical Institute Beato Matteo
Vigevano, Pavia, 27029
Brazil14 sites
Hospital Universitário João de Barros Barreto - UFPA
Belém, Pará, 66073-000
Centro de Pesquisa Clinica do Brasil
Brasília, Federal District, 71625175
Scentryphar Pesquisa Clínica Ltda
Campinas, São Paulo, 1302-431
Instituto de Pesquisa Clínica em Campinas
Campinas, São Paulo, 13060904
Universidade de Sao Paulo (USP) - Hospital das Clinicas da F
Cerqueira Cesar - Sao Paulo, São Paulo, Cep 05403-000
Quanta Diagnóstico e Terapia
Curitiba, Paraná, 80030-110
Hospital Universitário Walter Cantídio
Fortaleza, Ceará, 60430-370
Instituto de Estudos e Pesquisas Clínicas do Ceará - IEP/CE - Oncology
Fortaleza, 60160-230
Instituto Catarinense de Endocrinologia e Diabetes (ICED)
Joinville, Santa Catarina, 89201-260
Hospital Sao Vicente de Paulo
Passo Fundo- RS, Rio Grande do Sul, 99010-080
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90430-001
Hospital São Lucas da PUC-RS
Porto Alegre, Rio Grande do Sul, 90610-000
IPEC-Instituto de Pesquisa Clinica
São Paulo, São Paulo, 01223-001
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, 01228-000
Germany12 sites
Diabetologische Schwerpunktpraxis
Bad Berleburg, North Rhine-Westphalia, 57319
Studienzentrum Schwittay
Böhlen, 4564
Klinische Forschung Dresden GmbH
Dresden, Saxony, 0 1309
Universitätsklinikum Giessen und Marburg GmbH
Giessen, 32392
Klinische Forschung Hamburg GmbH
Hamburg, 20253
Clinical Research Hamburg GmbH
Hamburg, 22143
Israelitisches Krankenhaus
Hamburg, 22297
Klinische Forschung Hannover-Mitte GmbH
Hanover, 30159
KRH Klinikum Siloah
Hanover, 30459
Klinische Forschung Karlsruhe GmbH
Karlsruhe, Baden-Wurttemberg, 76137
Klinische Forschung Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, 19055
Praxis Dr. Etzrodt-Walter und Kollegen
Ulm, Baden-Wurttemberg, 89073
Russia12 sites
Kazan State Medical University
Kazan', 420012
Saint-Petersburg City Pokrovskaya Hospital
Leningrad Region, 199106
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, 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
Millitary-medical Academy, department of hospital therapy
Saint Petersburg, Sankt-Peterburg, 191124
MUZ City Clinical Hospital 9
Saratov, 410030
Saratov City Clinical Hospital 12
Saratov, 410039
France10 sites
Hôpital Louis-Mourier
Colombes, 92700
Corbeil Essonnes
Corbeil-Essonnes, 91106
Service d'hépato-gastroentérologie - 7°D
Grenoble, 38043
Hospices Civils de Lyon - Hôpital Edouard Herrriot
Lyon, 69437
CHU Nantes
Nantes, 44093
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, Gironde, 33604
CHU de Poitiers
Poitiers, 86021
Hopital Charles Nicolle
Rouen, 76031
CHRU Nancy
Vandœuvre-lès-Nancy, 54500
Centre de Recherche Clinique
Vénissieux, 69200
South Africa9 sites
FARMOVS
Bloemfontein, Free State, 9301
Synexus Helderberg Clinical Research Centre
Cape Town, 7130
TREAD Research
Cape Town, 7500
Soweto CTC
Johannesburg, Gauteng, 1818
Wits Clinical Research
Johannesburg, Gauteng, 2193
Endocare Research
Paarl, Western Cape, 7646
Synexus Stanza Clincal Reaserch Centre
Pretoria, Gauteng, 122
Syenxus Watermeyer Dedicated Research
Val de Grace, 184
Moriana Clinical Research
Winnie Mandela, 9400
Austria8 sites
VIVIT Institute, am LKH Feldkirch
Feldkirch, Vorarlberg, 6800
Medizinische Universitaet Innsbruck
Innsbruck, Tyrol, A-6020
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Ordination
Saint Stefan, Styria, 8511
Privatklinik Wehrle-Diakonissen
Salzburg, 5026
Oö. Gesundheits- und Spitals-AG/LKH Steyr
Steyr, 4400
Krankenanstalt Rudolfstiftung Wien
Vienna, 1030
KH Hietzing
Vienna, 1130
Colombia8 sites
Centro Cardiovascular y de Diabetes
Barranquilla, Atlántico, 80020
Fundación BIOS
Barranquilla, Atlántico, 80020
Endocare Ltda.
Bogota, Cundinamarca, 111111
Medplus Medicina Prepagada
Bogotá, Distrito Capltal, 110221
Centro Medico Imbanaco de Cali S.A.
Cali, Distrito Capltal, 760042
IPS Centro Medico Julian Coronel S.A
Cali, Valle del Cauca Department, 760035
Rodrigo Botero S.A.S.
Medellín, Antioquia, 50030
Healthy Medical Center
Zipaquirá, Cundinamarca, 250252
Hungary7 sites
Semmelweis University
Budapest, H-1088
Stra¡zshegy Medicina
Budapest, H1171
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, Heves County, H-3300
Coromed SMO
Pécs, Pécs, 7623
First Department of Medicine, University of Szeged
Szeged, Szaged, 6720
Hetenyi Geza Hospital
Szolnok, H-5004
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, Zala County, H-8900
Israel7 sites
Soroka University Medical Center
Beersheba, 84101
Bnai Zion M.C.
Haifa, 31048
E. Wolfson Medical Center
Holon, 58100
Digestive Diseases Institute
Jerusalem, 9103102
Gastroenterology Institute
Petah Tikva, 49100
Endocrinology & Diabetes Center
Safed, 13100
Gastroenterology Institute
Tel Aviv, 64239
Philippines7 sites
Perpetual Succor Hospital
Cebu City, 6000
West Visayas State University Medical Center
Iloilo City, 5000
Ospital ng Makati
Makati City, 1218
Manila Doctors Hospital
Manila, 1000
San Juan De Dios Educational Foundation, Inc.
Pasay, 1300
St. Luke's Medical Center
Quezon City, 1100
Cardinal Santos Medical Center
San Juan City, 1502
Spain7 sites
Hospital Universitario 12 de Octubre
Madrid, 20041
Hospital Clinico Universitario San Carlos
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Principe de Asturias
Madrid, 28850
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Virgen del Rocío
Seville, 41009
Hospital Universitario Miguel Servet
Zaragoza, 50009
Argentina6 sites
Maffei Centro Medico-Investigacion Clinica Aplicada
C.a.b.a., Buenos Aires, C1425AGC
Hospital Sirio Libanes
CABA, Buenos Aires, C1419AHN
CIPREC
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1119
Centro Universitario de Investigacion en Farmacologia Clinic
Corrientes, W3402BKE
Instituto de Investigaciones Clínicas de Rosario
Rosario, Santa Fe Province, 2000
Instituto de hematología y medicina clínica "Dr. Rubén Dávoli"
Rosario, Santa Fe Province, S200CFK
Bulgaria6 sites
MHAT Yuliya Vrevska Byala
Byala, 1303
MHAT Dobrich AD
Dobrich, 9300
MHAT Dr. Tota Venkova AD
Gabrovo, 5300
UMHAT - Kaspela- EOOD
Plovdiv, 4002
Medical Center Asklepion - Humane Medicine Research EOOD
Sofia, 1303
Alexandrovska University Hospital
Sofia, 1431
Australia5 sites
Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated
Adelaide, South Australia, 5000
Nepean Hospital
Kingswood, New South Wales, 2747
The Alfred Hospital
Melbourne, Victoria, 3004
Royal Melbourne Hospital
Parkville, Victoria, 3050
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Belgium5 sites
AZ Sint Lucas Brugge
Bruges, Antwerpen, 2650
Hôpitaux Iris Sud - Joseph Bracops
Brussels, 1070
Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
Edegem, Antwerpen, 2650
UZ Brussel
Jette, 1090
CHC - Clinique Saint-Joseph
Liège, 4000
Denmark5 sites
Aalborg University Hospital
Aalborg, 9000
MEA KFA
Aarhus, Århus, 8000
Steno Diabetes Center Copenhagen
Hellerup, 2900
Nordsjaellands Hospital
Hilleroed, 3400
Gastroenheden, Hvidovre hospital
Hvidovre, Kobenhavn, 2605
Romania5 sites
Sana Medical Center
Bucharest, 11025
National Institute of Endocrinology
Bucharest, 11863
AMES Research Center SRL
Calarasi, 910103
ClinTrial Medical Center, Pulmonology Department
Dobrosloveni Resca, Olt County, 237143
Polisano-Clinic
Sibiu, 550253
Latvia4 sites
Polana-D
Daugavpils, 5401
Ogorelova Jelena GP
Krāslava, 5601
Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
Riga, 1002
Digestive Diseases Centre GASTRO
Riga, 1006
Malaysia4 sites
Hospital Sultanah Bahiyah
Alor Star, Kedah, 5460
University Malaya Medical Centre
Kuala Lumpur, 59100
Universiti Sains Malaysia
Kubang Kerian, 16150
Hospital Taiping
Taiping, 34000
Singapore3 sites
National University Hospital
Singapore, 119228
Singapore General Hospital
Singapore, 169856
Changi General Hospital
Singapore, 529889
South Korea3 sites
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712
Sanggye Paik Hospital, Inje University College of Medicine
Seoul, 1757
Asan Medical Center
Seoul, 5505
Thailand3 sites
Phramongkutklao Hospital
Bangkok, 10400
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
About this study
Official title: Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis
This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.
- Conditions
- Gastroparesis
- Being tested
- Relamorelin 10 μg
- Keywords
- Diabetic Gastroparesis
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relamorelin 10 μgDrug
Relamorelin 10 μg injected subcutaneously twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Relamorelin 10 μg | Experimental | Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months. Receives: Drug: Relamorelin 10 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
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: Up to approximately 22 months
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Measured: Baseline (Day 1) up to approximately 22 months
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 approximately 22 months
Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Measured: Up to approximately 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start20 Dec 2018
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Why it stopped: The Relamorelin program is being terminated solely based on a business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harvy Schneier, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786380
- Sponsor's protocol ID
- 3071-305-020
- Other IDs
- 2019-000406-30, 2019
- Status last verified
- Nov 2021
- First submitted
- 21 Dec 2018
- Last updated
- 15 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT03786380
- Acronym / sponsor ID
- 3071-305-020
- Conditions
- Gastroparesis
- Keywords
- Diabetic Gastroparesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Relamorelin program is being terminated solely based on a business decision.
- Enrolment
- 202 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Posted 15 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relamorelin 10 μg | Experimental | Drug: Relamorelin 10 μgRelamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Successful completion of either Study RLM-MD-03 or Study RLM-MD-04
- Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures
- Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator.
Key exclusion criteria (4 listed)
- Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020
- Participant has an unresolved adverse event (AE) from a lead-in study, ie, 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
- Females who are pregnant, nursing, or planning a pregnancy during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relamorelin 10 μgRelamorelin 10 μg injected subcutaneously twice daily. | Drug | Relamorelin 10 μg |
Primary outcome
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 22 months
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.
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Time frame: Baseline (Day 1) up to approximately 22 months
Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Number of Participants With Clinically Meaningful Trends for Vital Signs
Time frame: Up to approximately 22 months
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.
Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results
Time frame: Up to approximately 22 months
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harvy Schneier study director
Allergan
486 sites in 30 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Relamorelin 10 μg in people with Gastroparesis, run by Allergan at 486 sites in 30 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 3 inclusion and 4 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 15 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 486 sites in United States, Ukraine, India, Mexico, United Kingdom and 25 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. 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 15 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?
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to approximately 22 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2021.