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

PHASE3TerminatedINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

February 1, 2018

Primary Completion Date

November 5, 2020

Study Completion Date

November 5, 2020

Conditions
GastroparesisDiabetes Mellitus
Interventions
DRUG

Placebo

Placebo injected subcutaneously twice daily.

DRUG

Relamorelin

Relamorelin 10 μg injected subcutaneously twice daily.

Trial Locations (349)

1000

Manila Doctors Hospital, Ermita, Manila

1002

Pauls Stradins Clinical University Hospital, Endokrinologijas nodala, Riga

1006

Digestive Diseases Centre GASTRO, Riga

1090

UZ Brussel, Jette

1100

St. Luke's Medical Center, Quezon City

1119

CIPREC, Buenos Aires

1218

Ospital ng Makati, Makati City

1300

San Juan De Dios Educational Foundation, Inc., Pasay

1303

Medical Center Asklepion - Humane Medicine Research EOOD, Sofia

1309

Klinische Forschung Dresden GmbH, Dresden

1431

Alexandrovska University Hospital, Sofia

1502

Cardinal Santos Medical Center, San Juan City

1757

Sanggye Paik Hospital, Inje University College of Medicine, Seoul

2193

Wits Clinical Research, Johannesburg

2605

Gastroenheden, Hvidovre hospital, Hvidovre

2650

Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,, Edegem

2747

Nepean Hospital, Kingswood

2900

Steno Diabetes Center Copenhagen, Hellerup

3049

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

3050

Royal Melbourne Hospital, Parkville

4000

Clinica Mayo de Urgencias Medicas Cruz Blanca SRL, San Miguel de Tucumán

4002

UMHAT - Kaspela- EOOD, Plovdiv

4050

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

4400

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

4564

Studienzentrum Schwittay, Böhlen

5000

Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated, Adelaide

West Visayas State University Medical Center, Iloilo City

5020

Privatklinik wehlre-Diakonissen, Salzburg

5460

Hospital Sultanah Bahiyah, Alor Star

5601

Kraslava Hospital, Krāslava

6000

Perpetual Succor Hospital, Cebu City

6807

VIVIT Institute, am LKH Feldkirch, Feldkirch

7100

MHAT Yuliya Vrevska Byala, Byala

7130

Synexus Helderberg Clinical Research Centre, Somerset West

8310

AZ Sint Lucas Brugge, Bruges

8511

Ordination, Osterreicher

9301

FARMOVS, Bloemfontein

10400

Phramongkutklao Hospital, Bangkok

10455

CHEAR Center LLC, The Bronx

10700

Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok

11023

Long Island Gastrointestinal Research Group LLP, Great Neck

11650

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

13790

United Health Services Hospitals, Inc., Johnson City

14000

Centro de Atención e Investigación en Factores de Riesgo Car, Mexico City

15212

Allegheny Endocrinology Associates, Pittsburgh

15236

Preferred Primary Care Physicians, Inc., Pittsburgh

15401

Preferred Primary Care Physicians, Uniontown

15478

Frontier Clinical Research, LLC, Smithfield

15683

Frontier Clinical Research, LLC, Scottdale

16150

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

18840

Guthrie Clinical Research, Sayre

19056

Family Medical Associates, Research Department, Levittown

20110

Manassas Clinical Research Centre, Manassas

20230

Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV, Aguascalientes

Hospital Cardiologica Aguascalientes, Aguascalientes

20815

Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research, Chevy Chase

20854

Meridian Clinical Research, LLC, Rockville

21001

Private Small-Scale Enterprise Medical Centre Pulse, Vinnytsia

21010

Vinnytsia Regional Clinical highly specialized Endocrinology Centre, Vinnytsia

21045

Gastro Center of Maryland, Columbia

21061

Woodholme Gastroenterology Associates, P.A., Glen Burnie

21701

Frederick Gastroenterology Associates, PA an Elligo Health Research Site, Frederick

21742

Meritus Center for Clinical Research, Hagerstown

22031

Verity Research Inc., Fairfax

22143

Clinical Research Hamburg, Hamburg

22297

Israelitisches Krankenhaus, Hamburg

23249

VA Medical Center McGuire VAMC, Richmond

24502

Blue Ridge Medical Research, Lynchburg

26506

West Virginia University, Morgantown

27103

PMG Research of Winston-Salem, LLC, Winston-Salem

The Center for Clinical Research, Winston-Salem

27410

Triad Clinical Trials, Greensboro

28025

Carolina Digestive Health Associates, PA, Concord

28144

PMG Research Salisbury, Salisbury

28204

Carolinas Healthcare-Charlotte, Charlotte

28304

Cumberland Research Associates, LLC, Fayetteville

28401

PMG Research of Wilmington, LLC, Wilmington

28403

Trial Management Associates, LLC, Wilmington

28501

Vidant Multispeciality Clinic - Kinston, Kinston

28557

Diabetes and Endocrinology Consultants, PC, Morehead City

28801

Asheville Gastroenterology Associates, Asheville

28850

Hospital Universitario Principe de Asturias, Madrid

29325

Carolina Medical Research, Clinton

29406

Clinical Trials of South Carolina, Charleston

29615

Gastroenterology Associates, PA, Greenville

29621

Synexus Clinical Research US, Inc., Anderson

Synexus Clinical Research US, Inc, Anderson

29650

Synexus Clinical Research, Greer

30024

Clinical Research Consultants of Atlanta, Suwanee

30030

iResearch Atlanta LLC, Decatur

30274

Infinite Clinical Trials, Riverdale

30318

Atlanta Diabetes Associates, Atlanta

30459

KRH Klinikum Siloah, Hanover

30513

River Birch Research Alliance, LLC, Blue Ridge

30519

Gwinnett Research Institute, LLC, Buford

30521

Summit Clinical Research, LLC., Carnesville

31948

Bnei-Zion MC, Haifa

33014

Savin Medical Group LLC, Miami Lakes

33016

Palmetto Research, LLC, Hialeah

33024

ALL Medical Research, LLC, Cooper City

33030

Vida Clinical Trials, Homestead

33134

APF Research LLC, Miami

33169

AMPM Research Clinic, Miami

33174

Advanced Medical Research Institute, Miami

Florida Research Center, Inc., Miami

33175

American Research Institute, Inc, Miami

33189

Top Medical Research, Cutler Bay

33756

Innovative Research of West FL, Inc., Clearwater

33765

Clinical Research of West Florida, Clearwater

33781

Synexus, Pinellas Park

34000

Hospital Taiping, Taiping

34060

Dioderm Instituto de Investigacion, Durango

34102

Gastroenterology Group of Naples, Naples

34270

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

34452

Nature Coast Clinical Research, Inverness

34761

Sensible Healthcare, Ocoee

35211

Simon Williamson Clinic, Birmingham

35611

North Alabama Research Center, LLC, Athens

35801

Avant Research Associates, Huntsville

36011

Poltava Regional Clinical Hospital, Poltava

36207

Pinnacle Research Group, Anniston

36305

Digestive Health Specialist of the South East, Dothan

36535

G & L Research, LLC, Foley

36608

Alabama Medical Group, PC, Mobile

37211

Quality Medical Research, Nashville

37421

Clinsearch, Chattanooga

37604

East Tennessee Research Institute, Johnson City

38138

Gastroenterology Centers of the Midsouth, Germantown

40202

University of Louisville, Louisville

41018

"St. Elizabeth Healthcare †Clinical Research Institute", Erlanger

43201

Endocrinology Research Associates, Inc., Columbus

43203

The Ohio State University, Wexner Medical Center, Columbus

43213

Aventiv Research, Inc., Columbus

43214

Hometown Urgent Care and Research, Columbus

44150

Unidad de Investigacion Clinica Cardiometabolica de Occidente, Guadalajara

44210

Consultorio particular, Guadalajara

44281

Family Practice Center of Wadsworth, Inc., Wadsworth

44311

Synexus Clinical Research US, Inc., Akron

44670

Unidad de Investigación Clínica en Medicina S.C/, Guadalajara

44718

Diabetes & Endocrinology Associates of Stark County, Inc., Canton

45005

Premier Clinical Research d.b.a. STAT Research, Franklin

45236

Synexus Clinical Research US - Cincinnati, Cincinnati

45249

Synexus Clinical Research US, Inc, Cincinnati

45409

CIC America Clinical Inquest Center Ltd., Dayton

45424

Hometown Urgent Care and Research, Dayton

45440

Dayton Gastroenterology,Inc., Beavercreek

47130

American Research, LLC, Jeffersonville

47714

MediSphere Medical Research Center, LLC, Evansville

Synexus Clinical Research US, Inc., Evansville

48047

Clinical Research Institute of Michigan, Chesterfield

48124

Vida Clinical Studies, Dearborn

48212

National Clinical, LLC, Hamtramck

48504

Aa Mrc, Llc, Flint

49027

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

49519

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

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

52242

University of Iowa Hospitals and Clinics, Iowa City

55423

Synexus Clinical Research US, Inc., Richfield

55446

MNGI Digestive Health, Coon Rapids

57702

Health Concepts, Rapid City

58001

Chernivtsi Regional Clinical Hospital, Chernivtsi

58022

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

59100

Clinical Investigation Centre, Kuala Lumpur

59808

Montana Medical Research, Missoula

60201

North Shore University Health System, Evanston

60453

Southwest Gastroenterology, Oak Lawn

61037

Municipal nonprofit entity of Kharkiv municipal council, Kharkiv

61070

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

63141

Synexus Clinical Research US, Inc, St Louis

65010

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

66160

University of Kansas Medical Center, Kansas City

66217

WestGlen Gastrointestinal Consultants, Shawnee Mission

66606

Cotton-O'Neil Clinical Research Center - Digestive Health, Topeka

Kansas Medical Clinic, Topeka

67124

Health Science Research Center, Pratt

67205

Professional Research Network of Kansas, LLC, Wichita

67208

Via Christi Clinic, PA, Wichita

68114

Diabetes and Endocrine Associates, P.C., Omaha

68134

Heartland Clinical Research, Inc, Omaha

69035

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

69600

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

70072

Tandem Clinical Research, Marrero

70360

Cronola LLC, Houma

70526

Avant Research Associates LLC, Crowley

70601

Clinical Trials of SWLA, LLC, Lake Charles

71111

WK Physicians Network, Bossier City

71291

Clinical Trials of America, Inc., West Monroe

72117

Arkansas Gastroenterology, North Little Rock

72143

Unity Health - Searcy Medical Center, Searcy

72211

Preferred Research Partners, Inc., Little Rock

72212

Applied Research Center of Arkansas, Little Rock

73000

Communal Institution Kherson City Clinical Hospital, Kherson

73111

Centennial Health-Synexus, Oklahoma City

73112

Digestive Disease Specialists Inc, Oklahoma City

73120

Memorial Clinical Research, Oklahoma City

74104

Options Health Research, LLC, Tulsa

75007

ClinRx Research, LLC, Carrollton

76008

Ivano-Frankivsk National Medical University, Ivano-Frankivsk

76012

Texas Clinical Research Institute, LLC, Arlington

76018

Ivano-Frankivsk Central City Clinical Hospital, Ivano-Frankivsk

76199

Klinische Forschung Karlsruhe GmbH, Karlsruhe

77030

Baylor College of Medicine Medical Center, Houston

77043

Biopharma Informatic Inc., Research Center, Houston

77079

Houston Endoscopy and Research Center, Inc., Houston

77083

Rodriguez Clinical Trials, Houston

77089

Amir Hassan, MD, PA, Houston

77701

DiscoveResearch, Inc., Beaumont

78028

Sante Clinical Research, Kerrville

78215

Pinnacle Clinical Research, San Antonio

78229

Clinical Trials of Texas, Inc., San Antonio

Sagact Pllc., San Antonio

Synexus Clinical Research US, Inc., San Antonio

80907

Peak Gastroenterology Associates, Colorado Springs

80909

Synexus, Colorado Springs

84041

Synexus Clinical Research US, Inc., Layton

84088

Advanced Clinical Research, West Jordan

84123

Synexus Clinical Research US, Inc., Murray

84405

Advanced Research Institute, Inc., Ogden

85014

Phoenix Clinical LLC., Phoenix

85710

Del Sol Research Management, LLC, Tucson

85712

Del Sol Research Management, LLC, Tucson

85741

Synexus Clinical Research US, Inc., Tucson

87108

Lovelace Scientific Resources, Inc., Albuquerque

89109

Excel Clinical Research, Las Vegas

89121

Clinical Research of South Nevada - CROSN, Las Vegas

89123

Advanced Biomedical Research of America, Las Vegas

89128

Digestive Disease Specialists, Las Vegas

89135

Palm Research Center, Las Vegas

90057

Angel City Research Inc., Los Angeles

90603

New Hope Research Development, Whittier

90717

Torrance Clinical Research Institute, Inc., Lomita

91303

Hope Clinical Research, Canoga Park

91786

Upland Clinical Research, Upland

91900

Sociedad de Metabolismo y Corazon S.C., Veracruz

91910

GW Research Inc, Chula Vista

92020

TriWest Research Associates, El Cajon

92024

Diagnamics Inc., Encinitas

92037

University of California San Diego, La Jolla

92083

Synexus Clinical Research US, Inc., Vista

92108

Optimal Research California, San Diego

92123

Medical Associates Research Group, Inc, San Diego

92627

Aurora Care Clinic, LLC, Costa Mesa

92705

Syrentis Clinical Research, Santa Ana

92845

VVCRD Research, Garden Grove

92879

Kindred Medical Institute for Clinical Trials, LLC, Corona

93534

Om Research LLC, Lancaster

94304

Stanford Hospital, Palo Alto

97070

Centro de Desarrollo Biomédico S.C.P, Mérida

97210

Northwest Gastroenterology Clinic, LLC, Portland

98405

Washington Gastroenterology PLLC, Tacoma

110060

Sir Ganga Ram Hospital (SGRH), Delhi

110221

Medplus Centro de Recuperacion Integral S.A.S., Bogotá

111111

Endocare Ltda., Bogotá

111311

Asociación Colombiana de Diabetes, Bogotá

119228

National University Hospital, Singapore

199106

Saint-Petersburg City Pokrovskaya Hospital, St-Petersburg

226003

M V Hospital & Research Centre, Lucknow

250252

Healthy Medical Center, Zipaquirá

302001

S R Kalla (SRK) Memorial Gastro & General Hospital, Jaipur

302012

Marudhar Hospital, Jaipur

302017

Eternal Hospital - Diabetology, Jaipur

SMS Hospital, Jaipur

344019

Rostov on Don, Rostov-on-Don

380007

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

380054

Zydus Hospital, Ahmedabad

400007

Bhatia Hospital, Mumbai

410030

GUZ Saratov City Clinical Hospital 9, Saratov

411001

B. J. Government Medical College and Sassoon General Hospitals, Pune

411011

Universal Hospital, Pune

411013

Noble Hospital, Pune

500072

Kumudini Devi Diabetes Research Center; Ramdevrao Hospital, Hyderabad

529889

Changi General Hospital, Singapore

530002

King George Hospital, Visakhapatnam

560002

Victoria Hospital Bangalore Medical College and Research Institute, Bengaluru

560092

Lifecare Clinic and Research Centre - Internal Med/Diabetology, Bangalore

560097

Rajalakshmi Hospital, Bengaluru

575003

Vinaya Hospital & Research Centre, Mangalore

600013

M.V. Hospital for Diabetes & Diabetes Research Centre, Chennai

625020

Arthur Asirvatham Hospital, Madurai

630117

Scientific Institute of Clinical and Experimental Lymphology, Novosibirsk

641009

Kovai Diabetes Speciality Centre, Coimbatore

660003

Centro de Investigaciones Clínicas IPS CARDIOMET Pereira, Pereira

760035

IPS Centro Medico Julian Coronel S.A, Santiago de Cali

760042

Centro Medico Imbanaco de Cali S.A., Santiago de Cali

71625175

Centro de Pesquisa Clinica do Brasil, Brasília

06606

Gastroenterology Associates of Fairfield County, P.C., Bridgeport

06518

Medical Research Center of Connecticut, LLC, Hamden

83404-7596

Rocky Mountain Diabetes and Osteoporosis Center, PA, Idaho Falls

08723

Garden State Endocrinology LLC, Brick

08302

Synexus Clinical Research US, Inc., Bridgeton

08234

AGA Clinical Research Associates, LLC, Egg Harbor

27599-7080

University of North Carolina at Chapel Hill, Chapel Hill

C1425AGC

Consultorios Asociados de Endocrinologia e Investigación Cl, Buenos Aires

C1419AHN

Hospital Sirio Libanes, CABA

B7600FYK

Centro de Investigaciones Medicas Mar del Plata SRL, Mar del Plata

S2000BIE

Instituto de Investigaciones Clinicas de Rosario, Rosario

S200CFK

Instituto Medico Catamarca-I.ME.C, Rosario

W3410AVV

Centro Universitario de Investigacion en Farmacologia Clinic, Corrientes

X5000AAW

Instituto Privado de Investigaciones Clinicas de Cordoba, Córdoba

X5000BNB

CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian, Córdoba

60430-270

Hospital Universitário Walter Cantídio, Fortaleza

66073-005

Hospital Universitário João de Barros Barreto - UFPA, Belém

90430-001

Núcleo de Pesquisa Clínica do Rio Grande do Sul, Porto Alegre

89201-260

Instituto Catarinense de Endocrinologia e Diabetes (ICED), Joinville

13020-431

Scentryphar Pesquisa Clínica Ltda, Campinas

13060-080

Instituto de Pesquisa Clinica em Campinas, Campinas

60160-230

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

01223-001

IPEC-Instituto de Pesquisa Clinica, São Paulo

01228-000

CPQuali Pesquisa Clinica Ltda, São Paulo

T2N 2T9

University of Calgary, Calgary

T4N 6V7

Central Alberta Research Centre, Red Deer

V5Z 1M9

Vancouver General Hospital, Vancouver

A1B 3V6

Patient research centre, St. John's

B4V 3N2

South Shore Medical Arts, Bridgewater

K1H 7W9

The Ottawa Hospital, Ottawa

L4L 4Y7

Toronto Digestive Disease Associates, Inc., Vaughan

H1M 1B1

Recherche GCP Research, Montreal

050030

Rodrigo Botero S.A.S., Medellín

050034

Centro Cardiovascular Colombiano Clínica Santa María, Medellín

080020

Centro Cardiovascular y de Diabetes, Barranquilla

Fundación del Caribe para la InvestigacionBiomédica-Fundación BIOS, Barranquilla

H-3300

Markhot Ferenc Oktatokorhaz es Rendelointezet, Eger

H-5004

Hetenyi Geza Hospital, Szolnok

H-8900

Zala Megyei Szent Rafael Korhaz, Zalaegerszeg

H1171

Strázsahegy Gyógyszertár Medicina, Budapest

H-6720

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

359-360

Diacon Hospital and research Center - Diabetology, Bengaluru

LV5401

Polana-D, Daugavpils

03300

Clinicos Asociados BOCM SC, Mexico City

06700

Mentrials Sa de Cv, Mexico City

30-539

Specjalistyczny Gabinet Neurologiczny Marta Banach, Krakow

31-530

CenterMed Krakow Ltd, Krakow

89-600

Centrum Medyczne Lukamed, Chojnice

S169856

Singapore General Hospital, Singapore

0122

Synexus Stanza Clinical Research Centre, Pretoria

0184

Watermeyer Clinical Research Site, Pretoria

561-712

Chonbuk National University Hospital, Jeonju

05505

Asan Medical Center, Seoul

NG7 2UH

Biomedical Research Centre, Nottingham

M13 9NQ

MAC Clinical Research Manchester, Manchester

MAC Clinical Research, GAC House, Manchester

OL1 2JH

Royal Oldham Hospital, Oldham

L34 1BH

MAC Clinical Research, Liverpool

WS11 0BH

MAC Research, Exchange House, Cannock

ST6 8DG

University Hospitals of North Midlands, Stoke-on-Trent

LS10 1DU

MAC Clinical Research, Monarch House, Leeds

S75 3DL

MAC Research, Barnsley

FY2 0JH

MAC Clinical Research, Kaman Court, Blackpool

CM1 7ET

Mid Essex Hospital Services NHS Trust Broomfield Hospital, Chelmsford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Allergan

INDUSTRY

NCT03383146 - A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04 | Biotech Hunter | Biotech Hunter