Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02

PHASE3TerminatedINTERVENTIONAL
Enrollment

311

Participants

Timeline

Start Date

February 16, 2018

Primary Completion Date

July 16, 2020

Study Completion Date

July 16, 2020

Conditions
GastroparesisDiabetes Mellitus
Interventions
DRUG

Placebo

Placebo injected subcutaneously twice daily.

DRUG

Relamorelin

Relamorelin 10 μg injected twice daily for 12 weeks.

Trial Locations (240)

184

Watermeyer Clinical Research Site, Silverton

1002

Pauls Stradins Clinical University Hospital, Endokrinologijas nodala, Riga

1006

Digestive Diseases Centre GASTRO, Riga

1036

Synexus Budapest DRS, Budapest

1090

UZ Brussel, Jette

1119

CIPREC, Buenos Aires

1309

Klinische Forschung Dresden GmbH, Dresden

2000

Instituto de Investigaciones Clinicas de Rosario, Rosario

2193

Wits Clinical Research, Johannesburg

2605

Gastroenheden, Hvidovre hospital, Hvidovre

2650

AZ Sint Lucas Brugge, Bruges

Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,, Edegem

2900

Center for Clinical Metabolic Research, Hellerup

3000

BKS Research Kft Synexus AS, Hatvan

4000

Clinica Mayo - Infectious DiseasesClínica Mayo de Urgencias, San Miguel de Tucumán

4025

SYNEXUS Magyarorszag Kft Debrecen A.S., Debrecen

4400

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

4564

Studienzentrum Schwittay, Böhlen

5020

Privatklinik Wehrle-Diakonissen, Salzburg

5401

Polana-D, Daugavpils

5601

Kraslava Hospital, Krāslava

5700

Synexus Magyarország kft. Gyula DRS, Gyula

6807

VIVIT Institute, am LKH Feldkirch, Feldkirch

7130

Synexus Helderberg Clinical Research Centre, Cape Town

7500

TREAD Research, Cape Town

8511

Ordination, Sankt Stefan

8900

Synexus Magyarorszag Kft, Zalaegerszeg

9301

FARMOVS, Bloemfontein

11432

Synexus Clinical Research US, Inc., Jamaica

11501

Winthrop-University Hospital, Mineola

11650

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

14000

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

15212

Allegheny Endocrinology Associates, Pittsburgh

15401

Preferred Primary Care Physicians, Uniontown

15478

Frontier Clinical Research, LLC, Smithfield

18840

Guthrie Clinical Research, Sayre

19104

University of Pennsylvania, Philadelphia

20110

Manassas Clinical Research Centre, Manassas

20230

Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV, Aguascalientes

Hospital Cardiologica Aguascalientes, Aguascalientes

20716

Trialspark - Sood, Bowie

20746

Capital Diabetes and Endocrine Associates, Camp Springs

20815

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

20854

Meridian Clinical Research, LLC, Rockville

21061

Woodholme Gastroenterology Associates, P.A., Glen Burnie

21742

Meritus Center for Clinical Research, Hagerstown

22143

Clinical Research Hamburg, Hamburg

22297

Israelitisches Krankenhaus, Hamburg

23249

VA Medical Center McGuire VAMC, Richmond

24502

Blue Ridge Medical Research, Lynchburg

27103

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

28036

Carolina Digestive Health Associates, PA, Davidson

28401

PMG Research of Wilmington, LLC, Wilmington

28501

Kinston Medical Specialists, P.A., Kinston

28557

Diabetes and Endocrinology Consultants, PC, Morehead City

29406

Clinical Trials of South Carolina, Charleston

29621

Synexus Clinical Research US, Inc., Anderson

30024

Clinical Research Consultants of Atlanta, Suwanee

30030

iResearch Atlanta LLC, Decatur

30318

Atlanta Diabetes Associates, Atlanta

30322

Emory University, Atlanta

30459

KRH Klinikum Siloah, Hanover

30513

River Birch Research Alliance, LLC, Blue Ridge

30519

Gwinnett Research Institute, LLC, Buford

32392

Clinical Research Unit, Giessen

33016

Palmetto Research, LLC, Hialeah

33024

ALL Medical Research LLC, Cooper City

33030

Vida Clinical Trials, Homestead

33157

Sanchez Clinical Research, Inc., Miami

33180

Visionary Investigators Network, Aventura

33331

Cleveland Clinic Florida - Weston, Weston

33765

Clinical Research of West Florida, Clearwater

33781

Synexus, Pinellas Park

34060

Dioderm Instituto de Investigacion, Durango

34102

Gastroenterology Group of Naples, Naples

35211

Synexus Clinical Research US - Simon Williamson Clinic, Birmingham

35611

North Alabama Research Center, LLC, Athens

36535

G & L Research, LLC, Foley

36608

Alabama Medical Group, PC, Mobile

37421

Clinsearch, Chattanooga

37604

East Tennessee Research Institute, Johnson City

38138

Gastro One, Germantown

41017

Tri-State Gastroenterology, Crestview Hills

43203

The Ohio State University, Wexner Medical Center, Columbus

43213

Aventiv Research, Inc., Columbus

44150

Unidad de Investigacion Clinica Cardiometabolica de Occidente, Guadalajara

44195

Digestive Disease & Surgery Institute, Cleveland

44311

Synexus Clinical Research US, Inc., Akron

44718

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

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

47130

American Research, LLC, Jeffersonville

47150

Gastroenterology of Southern Indiana, New Albany

48047

Clinical Research Institute of Michigan, Chesterfield

48504

Aa Mrc Llc, Flint

50030

Rodrigo Botero S.A.S., Medellín

57702

Health Concepts, Rapid City

60201

North Shore University Health System, Evanston

60602

Synexus Clinical Research US, Inc., Chicago

60611

Northwestern University Feinberg School of Medicine, Chicago

63110

Washington University in St. Louis, St Louis

63141

Synexus Clinical Research US, Inc, St Louis

66606

Kansas Medical Clinic, Topeka

67124

Health Science Research Center, Pratt

67205

Professional Research Network of Kansas, LLC, Wichita

67208

Via Christi Clinic, PA, Wichita

67214

WestGlen Gastrointestinal Consultants, Shawnee Mission

68134

Heartland Clinical Research, Inc, Omaha

70072

Tandem Clinical Research, Marrero

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

72143

Unity Health - Searcy Medical Center, Searcy

72212

Applied Research Center of Arkansas, Little Rock

73111

Centennial Health-Synexus, Oklahoma City

74104

Options Health Research, LLC, Tulsa

75007

ClinRx Research, LLC, Carrollton

76012

Texas Clinical Research Institute, LLC, Arlington

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

77479

Dwayne O. Williams MD, Sugar Land

78028

Sante Clinical Research, Kerrville

78215

Pinnacle Clinical Research, San Antonio

78229

Synexus Clinical Research US, Inc., San Antonio

78233

Digestive & Liver Disease Center of San Antonio, PLLC, San Antonio

80909

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

85741

Synexus Clinical Research US, Inc., Tucson

87108

Lovelace Scientific Resources, Inc., Albuquerque

90026

Angel City Research Inc., Los Angeles

90603

New Hope Research Development, Whittier

90717

Torrance Clinical Research Institute, Inc., Lomita

90822

Tibor Rubin VA Medical Center, Long Beach

91345

Facey Medical Foundation, Mission Hills

91910

GW Research Inc., Chula Vista

92024

Diagnamics Inc., Encinitas

92064

TriWest Research Associates, Poway

92108

Optimal Research California, San Diego

92563

United Medical Doctors, Murrieta

92705

Syrentis Clinical Research, Santa Ana

93720

Fresno Clinical Research Center, Fresno

94304

Stanford Hospital, Digestive Health Clinic, Palo Alto

97070

Centro de Desarrollo Biomedico S.C.P., Mérida

98405

Washington Gastroenterology PLLC, Tacoma

110221

Medplus Mp, Bogotá

111111

Endocare Ltda., Bogotá

111311

Asociación Colombiana de Diabetes, Bogotá

117036

FSBI National medical endocrinology research centre, Moscow

129110

Moscow Regional Research Clinical Institute named by MF Vladimirski, Moscow

191015

North-Western State Medical University named after I. I. Mechnikov, Saint Petersburg

199106

Saint-Petersburg City Pokrovskaya Hospital, St-Petersburg

250252

Healthy Medical Center, Zipaquirá

344019

Rostov on Don, Rostov-on-Don

344022

Rostov State Medical University, Rostov-on-Don

410030

GUZ Saratov City Clinical Hospital 9, Saratov

410039

Saratov City Clinical Hospital 12, Saratov

420012

Kazan State Medical University, Kazan'

603126

Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko, Nizhny Novgorod

630117

Scientific Institute of Clinical and Experimental Lymphology, Novosibirsk

660002

Fundacion Centro de Investigaciones Clinicas CARDIOMET, 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

06824

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

83404-7596

Rocky Mountain Diabetes and Osteoporosis Center, PA, Idaho Falls

02302

Commonwealth Clinical Studies, PLLC., Brockton

07201

USMA Clinical Research, LLC, Elizabeth

44109-1998

The MetroHealth System MHS, Cleveland

02886

Care Access Research, Warwick

C1425AGC

Maffei Centro Medico-Investigacion Clinica Aplicada, C.a.b.a.

C1419AHN

Hospital Sirio Libanes, CABA

B7600FYK

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

X5000AAW

Instituto Privado de Investigaciones Clínicas de Córdoba, Córdoba

S200CFK

Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli, Rosario

W3410AVV

Centro Universitario de Investigacion en Farmacologia Clinic, Corrientes

X5000BNB

CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian, Córdoba

60430-372

Hospital Universitario Walter Cantidio, Fortaleza

66073-000

Hospital Universitario Joao de Barros Barreto, 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 Clinica Ltda, Campinas

13060-080

Instituto de Pesquisa Clinica em Campinas, Campinas

01228-000

CPQuali Pesquisa Clinica Ltda, Santa Cecília

60160-230

Instituto de Estudos E Persquisas Clinicas do Ceará - IEP/CE - Oncology, Fortaleza

01223-001

Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda, São Paulo

T2N 2T9

University of Calgary, Calgary

T6G 2E1

Alberta Diabetes Institute, Edmonton

V5Z1M9

Gordon and Leslie Diamond Health Care Centre, Vancouver

A1B 3V6

Eastern Health, St. John's

B4V 2V6

South Shore Medical Arts, Bridgewater

K1H 7W9

The Ottawa Hospital, Ottawa

M4N 3M5

Sunnybrook Health Science Centre, Toronto

M5T 2S8

Toronto Western Hospital, University Health Network, Toronto

M6H 3M1

Toronto Liver Centre, Toronto

L4L 4YZ

Toronto Digestive Disease Associates, Vaughan

J4V 2H1

CISSS de la Monteregie-Centre, Greenfield Park

H1M 1B1

Recherche GCP Research, Montreal

H2X 0A9

Centre Hospitalier de l'Universite de Montreal - CHUM, Montreal

T4N 6V7

Central Alberta Research Centre, Red Deer

050034

Centro Cardiovascular Colombiano Clínica Santa María, Medellín

080020

Centro Cardiovascular y de Diabetes, Barranquilla

Fundacion Bios, Barranquilla

DK-9000

Endocrinology, Aalborg University Hospital, Aalborg

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 Tudomanyegyetem, Szeged

C.P. 44210

Consultorio Medico, Guadalajara

C.P. 44670

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

06700

Medical and Nutritional Trials, Cuauhtémoc

03300

Clinicos Asociados BOCM SC, Portales

C.P. 91900

Sociedad de Metabolismo y Corazon, S.C., Veracruz

0122

Synexus Stanza Clinical Research Centre, Pretoria

M13 9NQ

MAC Clinical Research Manchester, Manchester

MAC Clinical Research, GAC House, Manchester

PR7 7NA

Synexus Lancashire Dedicated Research Centre, Chorley

OL1 2JH

Royal Oldham Hospital, Oldham

WS11 0BH

MAC Research, Exchange House, Cannock

ST6 8DG

University Hospitals of North Midlands, Stoke-on-Trent

WV10 0QP

Royal Wolverhampton NHS Trust, Wolverhampton

LS10 1DU

MAC Clinical Research, Monarch House, Leeds

S75 3DL

MAC Research, Barnsley

FY2 0JH

MAC Clinical Research, Blackpool

CF15 9SS

Synexus Wales Clinical Research Centre, Cardiff

CM1 7ET

Mid Essex Hospital Services NHS Trust Broomfield Hospital, Chelmsford

EH4 2XU

Western General Hospital, Edinburgh

L22 0LG

Synexus Merseyside Dedicated Research Centre, Liverpool

L34 1BH

MAC Clinical Research, Liverpool

E1 2AJ

Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital, London

M15 6SX

Synexus Manchester Clinical Research Centre, Manchester

NE7 7DN

Royal Victoria Infirmary: Clinical Research Facility, Newcastle upon Tyne

NG7 2UH

Biomedical Research Centre, Nottingham

TS19 8PE

Synexus Hexham Dedicated Research Centre, Stockton-on-Tees

Synexus North Tees Clinical Research Centre, Stockton-on-Tees

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Allergan

INDUSTRY

NCT03426345 - Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02 | Biotech Hunter | Biotech Hunter