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AzTrials

GastroparesisPhase 3NCT03426345

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

A Phase 3 study testing Relamorelin in people with Gastroparesis and Diabetes Mellitus, run by Allergan at 240 sites in 15 countries.

Terminated

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

Official record
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Trial summary

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms. 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
311 participants
Where
240 sitesin 15 countries
Study dates
16 Feb 2018to 16 Jul 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

  • Diagnosis of Type 1 or Type 2 diabetes mellitus
  • Meet the per protocol criteria of diabetic gastroparesis
  • Compliance with diary
  • Compliance with the per protocol study treatment dosing instructions

Who cannot join

  • Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
  • Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1)
  • Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
  • History of gastrointestinal disorders that may be similar to gastroparesis
  • Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus

Trial locations and contacts

240 sites in 15 countries.

240 sites in 15 countries

United States114 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

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • North Alabama Research Center, LLC

    Athens, Alabama, 35611

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Emory University

    Atlanta, Georgia, 30322

  • Visionary Investigators Network

    Aventura, Florida, 33180

  • Synexus Clinical Research US - Simon Williamson Clinic

    Birmingham, Alabama, 35211

  • River Birch Research Alliance, LLC

    Blue Ridge, Georgia, 30513

  • WK Physicians Network

    Bossier City, Louisiana, 71111

  • Trialspark - Sood

    Bowie, Maryland, 20716

  • Gastroenterology Associates of Fairfield County, P.C.

    Bridgeport, Connecticut, 06824

  • Commonwealth Clinical Studies, PLLC.

    Brockton, Massachusetts, 02302

  • Gwinnett Research Institute, LLC

    Buford, Georgia, 30519

  • Capital Diabetes and Endocrine Associates

    Camp Springs, Maryland, 20746

  • Diabetes & Endocrinology Associates of Stark County, Inc.

    Canton, Ohio, 44718

  • ClinRx Research, LLC

    Carrollton, Texas, 75007

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Clinsearch

    Chattanooga, Tennessee, 37421

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan, 48047

  • Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Synexus Clinical Research US, Inc.

    Chicago, Illinois, 60602

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • GW Research Inc.

    Chula Vista, California, 91910

  • Synexus Clinical Research US - Cincinnati

    Cincinnati, Ohio, 45236

  • Synexus Clinical Research US, Inc

    Cincinnati, Ohio, 45249

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • The MetroHealth System MHS

    Cleveland, Ohio, 44109-1998

  • Digestive Disease & Surgery Institute

    Cleveland, Ohio, 44195

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

    Colorado Springs, Colorado, 80909

  • The Ohio State University, Wexner Medical Center

    Columbus, Ohio, 43203

  • Aventiv Research, Inc.

    Columbus, Ohio, 43213

  • ALL Medical Research LLC

    Cooper City, Florida, 33024

  • Tri-State Gastroenterology

    Crestview Hills, Kentucky, 41017

  • Avant Research Associates LLC

    Crowley, Louisiana, 70526

  • Carolina Digestive Health Associates, PA

    Davidson, North Carolina, 28036

  • CIC America Clinical Inquest Center Ltd.

    Dayton, Ohio, 45409

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45424

  • iResearch Atlanta LLC

    Decatur, Georgia, 30030

  • USMA Clinical Research, LLC

    Elizabeth, New Jersey, 07201

  • Diagnamics Inc.

    Encinitas, California, 92024

  • North Shore University Health System

    Evanston, Illinois, 60201

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • G & L Research, LLC

    Foley, Alabama, 36535

  • Fresno Clinical Research Center

    Fresno, California, 93720

  • Gastro One

    Germantown, Tennessee, 38138

  • Woodholme Gastroenterology Associates, P.A.

    Glen Burnie, Maryland, 21061

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

  • Palmetto Research, LLC

    Hialeah, Florida, 33016

  • Vida Clinical Trials

    Homestead, Florida, 33030

  • 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

  • Rocky Mountain Diabetes and Osteoporosis Center, PA

    Idaho Falls, Idaho, 83404-7596

  • Synexus Clinical Research US, Inc.

    Jamaica, New York, 11432

  • American Research, LLC

    Jeffersonville, Indiana, 47130

  • East Tennessee Research Institute

    Johnson City, Tennessee, 37604

  • Sante Clinical Research

    Kerrville, Texas, 78028

  • Kinston Medical Specialists, P.A.

    Kinston, North Carolina, 28501

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana, 70601

  • 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, 90026

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Manassas Clinical Research Centre

    Manassas, Virginia, 20110

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Sanchez Clinical Research, Inc.

    Miami, Florida, 33157

  • Winthrop-University Hospital

    Mineola, New York, 11501

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • Alabama Medical Group, PC

    Mobile, Alabama, 36608

  • Diabetes and Endocrinology Consultants, PC

    Morehead City, North Carolina, 28557

  • United Medical Doctors

    Murrieta, California, 92563

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Gastroenterology of Southern Indiana

    New Albany, Indiana, 47150

  • Centennial Health-Synexus

    Oklahoma City, Oklahoma, 73111

  • Heartland Clinical Research, Inc

    Omaha, Nebraska, 68134

  • Stanford Hospital, Digestive Health Clinic

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Synexus

    Pinellas Park, Florida, 33781

  • Allegheny Endocrinology Associates

    Pittsburgh, Pennsylvania, 15212

  • 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

  • Meridian Clinical Research, LLC

    Rockville, Maryland, 20854

  • Pinnacle Clinical Research

    San Antonio, Texas, 78215

  • Synexus Clinical Research US, Inc.

    San Antonio, Texas, 78229

  • Digestive & Liver Disease Center of San Antonio, PLLC

    San Antonio, Texas, 78233

  • Optimal Research California

    San Diego, California, 92108

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Guthrie Clinical Research

    Sayre, Pennsylvania, 18840

  • Unity Health - Searcy Medical Center

    Searcy, Arkansas, 72143

  • WestGlen Gastrointestinal Consultants

    Shawnee Mission, Kansas, 67214

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Synexus Clinical Research US, Inc

    St Louis, Missouri, 63141

  • Dwayne O. Williams MD

    Sugar Land, Texas, 77479

  • Clinical Research Consultants of Atlanta

    Suwanee, Georgia, 30024

  • Washington Gastroenterology PLLC

    Tacoma, Washington, 98405

  • Kansas Medical Clinic

    Topeka, Kansas, 66606

  • Synexus Clinical Research US, Inc.

    Tucson, Arizona, 85741

  • Options Health Research, LLC

    Tulsa, Oklahoma, 74104

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Care Access Research

    Warwick, Rhode Island, 02886

  • Clinical Trials of America, Inc.

    West Monroe, Louisiana, 71291

  • Cleveland Clinic Florida - Weston

    Weston, Florida, 33331

  • 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

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

United Kingdom21 sites

  • MAC Research

    Barnsley, S75 3DL

  • MAC Clinical Research

    Blackpool, FY2 0JH

  • MAC Research, Exchange House

    Cannock, Staffordshire, WS11 0BH

  • Synexus Wales Clinical Research Centre

    Cardiff, CF15 9SS

  • Mid Essex Hospital Services NHS Trust Broomfield Hospital

    Chelmsford, CM1 7ET

  • Synexus Lancashire Dedicated Research Centre

    Chorley, Lancashire, PR7 7NA

  • Western General Hospital

    Edinburgh, EH4 2XU

  • MAC Clinical Research, Monarch House

    Leeds, West Yorkshire, LS10 1DU

  • Synexus Merseyside Dedicated Research Centre

    Liverpool, L22 0LG

  • MAC Clinical Research

    Liverpool, L34 1BH

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

    London, E1 2AJ

  • MAC Clinical Research Manchester

    Manchester, Greater Manchester, M13 9NQ

  • MAC Clinical Research, GAC House

    Manchester, M13 9NQ

  • Synexus Manchester Clinical Research Centre

    Manchester, M15 6SX

  • Royal Victoria Infirmary: Clinical Research Facility

    Newcastle upon Tyne, NE7 7DN

  • Biomedical Research Centre

    Nottingham, NG7 2UH

  • Royal Oldham Hospital

    Oldham, Lancashire, OL1 2JH

  • Synexus Hexham Dedicated Research Centre

    Stockton-on-Tees, TS19 8PE

  • Synexus North Tees Clinical Research Centre

    Stockton-on-Tees, TS19 8PE

  • University Hospitals of North Midlands

    Stoke-on-Trent, Staffordshire, ST6 8DG

  • Royal Wolverhampton NHS Trust

    Wolverhampton, West Midlands, WV10 0QP

Other trials in United Kingdom

Canada14 sites

  • South Shore Medical Arts

    Bridgewater, Nova Scotia, B4V 2V6

  • University of Calgary

    Calgary, Alberta, T2N 2T9

  • Alberta Diabetes Institute

    Edmonton, Alberta, T6G 2E1

  • 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, 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

  • Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z1M9

  • Toronto Digestive Disease Associates

    Vaughan, Ontario, L4L 4YZ

Other trials in Canada

Mexico12 sites

  • Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV

    Aguascalientes, 20230

  • Hospital Cardiologica Aguascalientes

    Aguascalientes, 20230

  • Medical and Nutritional Trials

    Cuauhtémoc, Mexico City, 06700

  • Dioderm Instituto de Investigacion

    Durango, 34060

  • Unidad de Investigacion Clinica Cardiometabolica de Occidente

    Guadalajara, Jalisco, 44150

  • Consultorio Medico

    Guadalajara, Jalisco, C.P. 44210

  • Unidad de Investigación Clínica en Medicina S.C.

    Guadalajara, Jalisco, C.P. 44670

  • Centro de Desarrollo Biomedico S.C.P.

    Mérida, Yucatán, 97070

  • 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

  • Clinicos Asociados BOCM SC

    Portales, Mexico City, 03300

  • Sociedad de Metabolismo y Corazon, S.C.

    Veracruz, C.P. 91900

Other trials in Mexico

Colombia11 sites

  • Centro Cardiovascular y de Diabetes

    Barranquilla, Atlántico, 080020

  • Fundacion Bios

    Barranquilla, Atlántico, 080020

  • Medplus Mp

    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

  • Centro Cardiovascular Colombiano Clínica Santa María

    Medellín, Antioquia, 050034

  • Rodrigo Botero S.A.S.

    Medellín, Antioquia, 50030

  • Fundacion Centro de Investigaciones Clinicas CARDIOMET

    Pereira, Risaralda Department, 660002

  • Healthy Medical Center

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Russia11 sites

  • Kazan State Medical University

    Kazan', 420012

  • FSBI National medical endocrinology research centre

    Moscow, 117036

  • Moscow Regional Research Clinical Institute named by MF Vladimirski

    Moscow, 129110

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

    Nizhny Novgorod, Volga, 603126

  • Scientific Institute of Clinical and Experimental Lymphology

    Novosibirsk, Novosibirsk Oblast, 630117

  • Rostov on Don

    Rostov-on-Don, 344019

  • Rostov State Medical University

    Rostov-on-Don, 344022

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

    Saint Petersburg, 191015

  • GUZ Saratov City Clinical Hospital 9

    Saratov, Saratov Oblast, 410030

  • Saratov City Clinical Hospital 12

    Saratov, 410039

  • Saint-Petersburg City Pokrovskaya Hospital

    St-Petersburg, Leningradskaya Oblast', 199106

Other trials in Russia

Argentina10 sites

  • CIPREC

    Buenos Aires, 1119

  • Maffei Centro Medico-Investigacion Clinica Aplicada

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

  • Hospital Sirio Libanes

    CABA, Buenos Aires, C1419AHN

  • Instituto Privado de Investigaciones Clínicas de Córdoba

    Córdoba, Córdoba Province, X5000AAW

  • 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, 2000

  • Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli

    Rosario, Santa Fe Province, S200CFK

  • Clinica Mayo - Infectious DiseasesClínica Mayo de Urgencias

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Brazil10 sites

  • Hospital Universitario Joao de Barros Barreto

    Belém, Pará, 66073-000

  • Centro de Pesquisa Clinica do Brasil

    Brasília, Federal District, 71625175

  • Scentryphar Pesquisa Clinica Ltda

    Campinas, São Paulo, 13020-431

  • Instituto de Pesquisa Clinica em Campinas

    Campinas, São Paulo, 13060-080

  • Hospital Universitario Walter Cantidio

    Fortaleza, Ceará, 60430-372

  • Instituto de Estudos E Persquisas Clinicas do Ceará - 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

  • CPQuali Pesquisa Clinica Ltda

    Santa Cecília, São Paulo, 01228-000

  • Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda

    São Paulo, 01223-001

Other trials in Brazil

Hungary10 sites

  • Synexus Budapest DRS

    Budapest, 1036

  • Strázsahegy Gyógyszertár Medicina

    Budapest, H1171

  • SYNEXUS Magyarorszag Kft Debrecen A.S.

    Debrecen, 4025

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, Heves County, H-3300

  • Synexus Magyarország kft. Gyula DRS

    Gyula, 5700

  • BKS Research Kft Synexus AS

    Hatvan, Heves County, 3000

  • Szegedi Tudomanyegyetem

    Szeged, H-6720

  • Hetenyi Geza Hospital

    Szolnok, Jász-Nagykun-Szolnok, H-5004

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, Zala County, H-8900

  • Synexus Magyarorszag Kft

    Zalaegerszeg, 8900

Other trials in Hungary

Germany7 sites

  • Studienzentrum Schwittay

    Böhlen, Saxony, 4564

  • Klinische Forschung Dresden GmbH

    Dresden, Saxony, 1309

  • Clinical Research Unit

    Giessen, 32392

  • Clinical Research Hamburg

    Hamburg, 22143

  • Israelitisches Krankenhaus

    Hamburg, 22297

  • KRH Klinikum Siloah

    Hanover, 30459

  • Klinische Forschung Karlsruhe GmbH

    Karlsruhe, Baden-SWürttemberg, 76199

Other trials in Germany

South Africa6 sites

  • FARMOVS

    Bloemfontein, Free State, 9301

  • Synexus Helderberg Clinical Research Centre

    Cape Town, Western Cape, 7130

  • TREAD Research

    Cape Town, 7500

  • Wits Clinical Research

    Johannesburg, Gauteng, 2193

  • Synexus Stanza Clinical Research Centre

    Pretoria, Gauteng, 0122

  • Watermeyer Clinical Research Site

    Silverton, Gauteng, 184

Other trials in South Africa

Austria4 sites

  • VIVIT Institute, am LKH Feldkirch

    Feldkirch, Vorarlberg, 6807

  • Privatklinik Wehrle-Diakonissen

    Salzburg, 5020

  • Ordination

    Sankt Stefan, Styria, 8511

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

    Steyr, 4400

Other trials in Austria

Latvia4 sites

  • Polana-D

    Daugavpils, 5401

  • Kraslava Hospital

    Krāslava, 5601

  • Pauls Stradins Clinical University Hospital, Endokrinologijas nodala

    Riga, 1002

  • Digestive Diseases Centre GASTRO

    Riga, 1006

Other trials in Latvia

Belgium3 sites

  • AZ Sint Lucas Brugge

    Bruges, Antwerpen, 2650

  • Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,

    Edegem, Antwerp, 2650

  • UZ Brussel

    Jette, Brussels Capital, 1090

Other trials in Belgium

Denmark3 sites

  • Endocrinology, Aalborg University Hospital

    Aalborg, DK-9000

  • Center for Clinical Metabolic Research

    Hellerup, 2900

  • Gastroenheden, Hvidovre hospital

    Hvidovre, Copenhagen, 2605

Other trials in Denmark

About this study

Official title: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

Being tested
Placebo, Relamorelin
Medical subject headings
Gastroparesis, Diabetes Mellitus

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 twice daily for 12 weeks.

Study groups in NCT03426345
Study groupRoleWhat they receive
PlaceboPlacebo comparatorFollowing a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
Receives: Drug: Placebo
Relamorelin 10 μgExperimentalFollowing a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.
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.

    Measured: Baseline (Day-14 to Day-1) to Week 12

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

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

    Measured: Week 6 to Week 12

Secondary outcomes (10)

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

    A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0= no nausea to 10= worst possible nausea.

    Measured: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

  2. Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period

    An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0= no abdominal pain to 10= the worst possible abdominal pain and was recorded in an e-diary.

    Measured: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

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

    A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0= no bloating and 10= the worst possible bloating and was recorded in the e-diary.

    Measured: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

  4. Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period

    A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0= no feeling of fullness until finishing a meal (best) to 10= feeling full after only a few bites (worst).

    Measured: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

  5. 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: Up to approximately 16 weeks

  6. 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: Up to 12 weeks

  7. 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 12 weeks

  8. 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 12 weeks

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

    Measured: Baseline (Day 1) up to 12 weeks

  10. 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 14, Day 28, Day 84, and End of Treatment (Up to Day 84)

Timeline

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

  1. First posted8 Feb 2018
  2. Study start16 Feb 2018
  3. Primary completion16 Jul 2020
  4. Study completion16 Jul 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
Double blind
Who is masked
Participant, Investigator
Enrolment
311 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03426345
Sponsor's protocol ID
RLM-MD-02
Other IDs
2017-002177-20, 2017
Status last verified
Jul 2021
First submitted
2 Feb 2018
Last updated
6 Aug 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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 240 sites in 15 countries.

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

Who may be eligible to take part?

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

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 240 sites in United States, United Kingdom, Canada, Mexico, Colombia and 10 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 6 Aug 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 (Day-14 to Day-1) to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03426345.

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 6 Aug 2021.

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