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

• ClinicalTrials.gov Identifier: NCT03426345
• Recruitment Status: Terminated
• First Posted: February 8, 2018
• Results First Posted: August 6, 2021
• Last Update Posted: August 6, 2021
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Gastroparesis; Diabetes Mellitus	Drug: Placebo; Drug: Relamorelin	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 311 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 16, 2018
• Actual Primary Completion Date: July 16, 2020
• Actual Study Completion Date: July 16, 2020

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Drug: Placebo; Placebo injected subcutaneously twice daily.
Experimental: Relamorelin 10 μg; Following a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.	Drug: Relamorelin; Relamorelin 10 μg injected twice daily for 12 weeks.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.
2. Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Week 6 to Week 12 ]
   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.

Secondary Outcome Measures :

1. Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12) ]
   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.
2. Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12) ]
   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.
3. Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12) ]
   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.
4. Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12) ]
   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).
5. Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Up to approximately 16 weeks ]
   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.
6. Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results [ Time Frame: Up to 12 weeks ]
   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.
7. Number of Participants With Clinically Meaningful Trends for Vital Signs [ Time Frame: Up to 12 weeks ]
   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.
8. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results [ Time Frame: Up to 12 weeks ]
   A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
9. Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) [ Time Frame: Baseline (Day 1) up to 12 weeks ]
10. Number of Participants With Anti-relamorelin Antibody Testing Results by Visit [ Time Frame: Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84) ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, Alabama

North Alabama Research Center, LLC

Athens, Alabama, United States, 35611

Synexus Clinical Research US - Simon Williamson Clinic

Birmingham, Alabama, United States, 35211

G & L Research, LLC

Foley, Alabama, United States, 36535

Alabama Medical Group, PC

Mobile, Alabama, United States, 36608

United States, Arizona

Synexus Clinical Research US, Inc.

Tucson, Arizona, United States, 85741

United States, Arkansas

Applied Research Center of Arkansas

Little Rock, Arkansas, United States, 72212

Unity Health - Searcy Medical Center

Searcy, Arkansas, United States, 72143

United States, California

GW Research Inc.

Chula Vista, California, United States, 91910

Diagnamics Inc.

Encinitas, California, United States, 92024

Fresno Clinical Research Center

Fresno, California, United States, 93720

Torrance Clinical Research Institute, Inc.

Lomita, California, United States, 90717

Tibor Rubin VA Medical Center

Long Beach, California, United States, 90822

Angel City Research Inc.

Los Angeles, California, United States, 90026

Facey Medical Foundation

Mission Hills, California, United States, 91345

United Medical Doctors

Murrieta, California, United States, 92563

Stanford Hospital, Digestive Health Clinic

Palo Alto, California, United States, 94304

TriWest Research Associates

Poway, California, United States, 92064

Optimal Research California

San Diego, California, United States, 92108

Syrentis Clinical Research

Santa Ana, California, United States, 92705

New Hope Research Development

Whittier, California, United States, 90603

United States, Colorado

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

Colorado Springs, Colorado, United States, 80909

United States, Connecticut

Gastroenterology Associates of Fairfield County, P.C.

Bridgeport, Connecticut, United States, 06824

United States, Florida

Visionary Investigators Network

Aventura, Florida, United States, 33180

Clinical Research of West Florida

Clearwater, Florida, United States, 33765

ALL Medical Research LLC

Cooper City, Florida, United States, 33024

Palmetto Research, LLC

Hialeah, Florida, United States, 33016

Vida Clinical Trials

Homestead, Florida, United States, 33030

Sanchez Clinical Research, Inc.

Miami, Florida, United States, 33157

Gastroenterology Group of Naples

Naples, Florida, United States, 34102

Synexus

Pinellas Park, Florida, United States, 33781

Cleveland Clinic Florida - Weston

Weston, Florida, United States, 33331

United States, Georgia

Atlanta Diabetes Associates

Atlanta, Georgia, United States, 30318

Emory University

Atlanta, Georgia, United States, 30322

River Birch Research Alliance, LLC

Blue Ridge, Georgia, United States, 30513

Gwinnett Research Institute, LLC

Buford, Georgia, United States, 30519

iResearch Atlanta LLC

Decatur, Georgia, United States, 30030

Clinical Research Consultants of Atlanta

Suwanee, Georgia, United States, 30024

United States, Idaho

Rocky Mountain Diabetes and Osteoporosis Center, PA

Idaho Falls, Idaho, United States, 83404-7596

United States, Illinois

Synexus Clinical Research US, Inc.

Chicago, Illinois, United States, 60602

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611

North Shore University Health System

Evanston, Illinois, United States, 60201

United States, Indiana

American Research, LLC

Jeffersonville, Indiana, United States, 47130

Gastroenterology of Southern Indiana

New Albany, Indiana, United States, 47150

United States, Kansas

Health Science Research Center

Pratt, Kansas, United States, 67124

WestGlen Gastrointestinal Consultants

Shawnee Mission, Kansas, United States, 67214

Kansas Medical Clinic

Topeka, Kansas, United States, 66606

Professional Research Network of Kansas, LLC

Wichita, Kansas, United States, 67205

Via Christi Clinic, PA

Wichita, Kansas, United States, 67208

United States, Kentucky

Tri-State Gastroenterology

Crestview Hills, Kentucky, United States, 41017

United States, Louisiana

WK Physicians Network

Bossier City, Louisiana, United States, 71111

Avant Research Associates LLC

Crowley, Louisiana, United States, 70526

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, United States, 70601

Tandem Clinical Research

Marrero, Louisiana, United States, 70072

Clinical Trials of America, Inc.

West Monroe, Louisiana, United States, 71291

United States, Maryland

Trialspark - Sood

Bowie, Maryland, United States, 20716

Capital Diabetes and Endocrine Associates

Camp Springs, Maryland, United States, 20746

Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

Chevy Chase, Maryland, United States, 20815

Woodholme Gastroenterology Associates, P.A.

Glen Burnie, Maryland, United States, 21061

Meritus Center for Clinical Research

Hagerstown, Maryland, United States, 21742

Meridian Clinical Research, LLC

Rockville, Maryland, United States, 20854

United States, Massachusetts

Commonwealth Clinical Studies, PLLC.

Brockton, Massachusetts, United States, 02302

United States, Michigan

Clinical Research Institute of Michigan

Chesterfield, Michigan, United States, 48047

Aa Mrc Llc

Flint, Michigan, United States, 48504

United States, Missouri

Washington University in St. Louis

Saint Louis, Missouri, United States, 63110

Synexus Clinical Research US, Inc

Saint Louis, Missouri, United States, 63141

United States, Nebraska

Heartland Clinical Research, Inc

Omaha, Nebraska, United States, 68134

United States, New Jersey

USMA Clinical Research, LLC

Elizabeth, New Jersey, United States, 07201

United States, New Mexico

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, United States, 87108

United States, New York

Synexus Clinical Research US, Inc.

Jamaica, New York, United States, 11432

Winthrop-University Hospital

Mineola, New York, United States, 11501

United States, North Carolina

Carolina Digestive Health Associates, PA

Davidson, North Carolina, United States, 28036

Kinston Medical Specialists, P.A.

Kinston, North Carolina, United States, 28501

Diabetes and Endocrinology Consultants, PC

Morehead City, North Carolina, United States, 28557

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States, 28401

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States, 27103

United States, Ohio

Synexus Clinical Research US, Inc.

Akron, Ohio, United States, 44311

Diabetes & Endocrinology Associates of Stark County, Inc.

Canton, Ohio, United States, 44718

Synexus Clinical Research US - Cincinnati

Cincinnati, Ohio, United States, 45236

Synexus Clinical Research US, Inc

Cincinnati, Ohio, United States, 45249

The MetroHealth System MHS

Cleveland, Ohio, United States, 44109-1998

Digestive Disease & Surgery Institute

Cleveland, Ohio, United States, 44195

The Ohio State University, Wexner Medical Center

Columbus, Ohio, United States, 43203

Aventiv Research, Inc.

Columbus, Ohio, United States, 43213

CIC America Clinical Inquest Center Ltd.

Dayton, Ohio, United States, 45409

Hometown Urgent Care and Research

Dayton, Ohio, United States, 45424

United States, Oklahoma

Centennial Health-Synexus

Oklahoma City, Oklahoma, United States, 73111

Options Health Research, LLC

Tulsa, Oklahoma, United States, 74104

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, United States, 15212

Guthrie Clinical Research

Sayre, Pennsylvania, United States, 18840

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, United States, 15478

Preferred Primary Care Physicians

Uniontown, Pennsylvania, United States, 15401

United States, Rhode Island

Care Access Research

Warwick, Rhode Island, United States, 02886

United States, South Carolina

Synexus Clinical Research US, Inc.

Anderson, South Carolina, United States, 29621

Clinical Trials of South Carolina

Charleston, South Carolina, United States, 29406

United States, South Dakota

Health Concepts

Rapid City, South Dakota, United States, 57702

United States, Tennessee

Clinsearch

Chattanooga, Tennessee, United States, 37421

Gastro One

Germantown, Tennessee, United States, 38138

East Tennessee Research Institute

Johnson City, Tennessee, United States, 37604

United States, Texas

Texas Clinical Research Institute, LLC

Arlington, Texas, United States, 76012

ClinRx Research, LLC

Carrollton, Texas, United States, 75007

Baylor College of Medicine Medical Center

Houston, Texas, United States, 77030

Biopharma Informatic Inc., Research Center

Houston, Texas, United States, 77043

Houston Endoscopy and Research Center, Inc.

Houston, Texas, United States, 77079

Rodriguez Clinical Trials

Houston, Texas, United States, 77083

Sante Clinical Research

Kerrville, Texas, United States, 78028

Pinnacle Clinical Research

San Antonio, Texas, United States, 78215

Synexus Clinical Research US, Inc.

San Antonio, Texas, United States, 78229

Digestive & Liver Disease Center of San Antonio, PLLC

San Antonio, Texas, United States, 78233

Dwayne O. Williams MD

Sugar Land, Texas, United States, 77479

United States, Virginia

Blue Ridge Medical Research

Lynchburg, Virginia, United States, 24502

Manassas Clinical Research Centre

Manassas, Virginia, United States, 20110

VA Medical Center McGuire VAMC

Richmond, Virginia, United States, 23249

United States, Washington

Washington Gastroenterology PLLC

Tacoma, Washington, United States, 98405

Argentina

Maffei Centro Medico-Investigacion Clinica Aplicada

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

Hospital Sirio Libanes

Caba, Buenos Aires Province, Argentina, C1419AHN

Centro de Investigaciones Medicas Mar del Plata SRL

Mar del Plata, Buenos Aires Province, Argentina, B7600FYK

Instituto Privado de Investigaciones Clínicas de Córdoba

Córdoba, Cordoba, Argentina, X5000AAW

Instituto de Investigaciones Clinicas de Rosario

Rosario, Santa Fe, Argentina, 2000

Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli

Rosario, Santa Fe, Argentina, S200CFK

Clinica Mayo - Infectious DiseasesClínica Mayo de Urgencias

San Miguel de Tucuman, Tucuman, Argentina, 4000

CIPREC

Ciudad Autonoma de Buenos Aires, Argentina, 1119

Centro Universitario de Investigacion en Farmacologia Clinic

Corrientes, Argentina, W3410AVV

CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian

Córdoba, Argentina, X5000BNB

Austria

Ordination

Sankt Stefan, Steiermark, Austria, 8511

VIVIT Institute, am LKH Feldkirch

Feldkirch, Vorarlberg, Austria, 6807

Privatklinik Wehrle-Diakonissen

Salzburg, Austria, 5020

Oö. Gesundheits- und Spitals-AG/LKH Steyr

Steyr, Austria, 4400

Belgium

AZ Sint Lucas Brugge

Brugge, Antwerpen, Belgium, 2650

Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,

Edegem, Antwerp, Belgium, 2650

UZ Brussel

Jette, Brussel, Belgium, 1090

Brazil

Hospital Universitario Walter Cantidio

Fortaleza, Ceara, Brazil, 60430-372

Centro de Pesquisa Clinica do Brasil

Brasilia, Distrito Federal, Brazil, 71625175

Hospital Universitario Joao de Barros Barreto

Belem, Para, Brazil, 66073-000

Núcleo de Pesquisa Clínica do Rio Grande do Sul

Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001

Instituto Catarinense de Endocrinologia e Diabetes (ICED)

Joinville, Santa Catarina, Brazil, 89201-260

Scentryphar Pesquisa Clinica Ltda

Campinas, Sao Paulo, Brazil, 13020-431

Instituto de Pesquisa Clinica em Campinas

Campinas, Sao Paulo, Brazil, 13060-080

CPQuali Pesquisa Clinica Ltda

Santa Cecília, Sao Paulo, Brazil, 01228-000

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

Fortaleza, Brazil, 60160-230

Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda

SÃo Paulo, Brazil, 01223-001

Canada, Alberta

University of Calgary

Calgary, Alberta, Canada, T2N 2T9

Alberta Diabetes Institute

Edmonton, Alberta, Canada, T6G 2E1

Canada, British Columbia

Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, Canada, V5Z1M9

Canada, Newfoundland and Labrador

Eastern Health

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

Canada, Nova Scotia

South Shore Medical Arts

Bridgewater, Nova Scotia, Canada, B4V 2V6

Canada, Ontario

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 7W9

Sunnybrook Health Science Centre

Toronto, Ontario, Canada, M4N 3M5

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada, M5T 2S8

Toronto Liver Centre

Toronto, Ontario, Canada, M6H 3M1

Toronto Digestive Disease Associates

Vaughan, Ontario, Canada, L4L 4YZ

Canada, Quebec

CISSS de la Monteregie-Centre

Greenfield Park, Quebec, Canada, J4V 2H1

Recherche GCP Research

Montreal, Quebec, Canada, H1M 1B1

Centre Hospitalier de l'Universite de Montreal - CHUM

Montreal, Quebec, Canada, H2X 0A9

Canada

Central Alberta Research Centre

Red Deer, Canada, T4N 6V7

Colombia

Centro Cardiovascular Colombiano Clínica Santa María

Medellin, Antioquia, Colombia, 050034

Rodrigo Botero S.A.S.

Medellin, Antioquia, Colombia, 50030

Centro Cardiovascular y de Diabetes

Barranquilla, Atlantico, Colombia, 080020

Fundacion Bios

Barranquilla, Atlantico, Colombia, 080020

Asociación Colombiana de Diabetes

Bogotá, Cundinamarca, Colombia, 111311

Healthy Medical Center

Zipaquira, Cundinamarca, Colombia, 250252

Medplus Mp

Bogota, Distrito Capital De Bogotá, Colombia, 110221

Endocare Ltda.

Bogota, Distrito Capital De Bogotá, Colombia, 111111

Fundacion Centro de Investigaciones Clinicas CARDIOMET

Pereira, Risaralda, Colombia, 660002

IPS Centro Medico Julian Coronel S.A

Cali, Valle Del Cauca, Colombia, 760035

Centro Medico Imbanaco de Cali S.A.

Cali, Valle Del Cauca, Colombia, 760042

Denmark

Gastroenheden, Hvidovre hospital

Hvidovre, Copenhagen, Denmark, 2605

Endocrinology, Aalborg University Hospital

Aalborg, Denmark, DK-9000

Center for Clinical Metabolic Research

Hellerup, Denmark, 2900

Germany

Klinische Forschung Karlsruhe GmbH

Karlsruhe, Baden-SWürttemberg, Germany, 76199

Studienzentrum Schwittay

Böhlen, Saxony, Germany, 4564

Klinische Forschung Dresden GmbH

Dresden, Saxony, Germany, 1309

Clinical Research Unit

Giessen, Germany, 32392

Clinical Research Hamburg

Hamburg, Germany, 22143

Israelitisches Krankenhaus

Hamburg, Germany, 22297

KRH Klinikum Siloah

Hannover, Germany, 30459

Hungary

Markhot Ferenc Oktatokorhaz es Rendelointezet

Eger, Heves, Hungary, H-3300

BKS Research Kft Synexus AS

Hatvan, Heves, Hungary, 3000

Hetenyi Geza Hospital

Szolnok, Jász-Nagykun-Szolnok, Hungary, H-5004

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, Zala, Hungary, H-8900

Synexus Budapest DRS

Budapest, Hungary, 1036

Strázsahegy Gyógyszertár Medicina

Budapest, Hungary, H1171

SYNEXUS Magyarorszag Kft Debrecen A.S.

Debrecen, Hungary, 4025

Synexus Magyarország kft. Gyula DRS

Gyula, Hungary, 5700

Szegedi Tudomanyegyetem

Szeged, Hungary, H-6720

Synexus Magyarorszag Kft

Zalaegerszeg, Hungary, 8900

Latvia

Polana-D

Daugavpils, Latvia, 5401

Kraslava Hospital

Kraslava, Latvia, 5601

Pauls Stradins Clinical University Hospital, Endokrinologijas nodala

Riga, Latvia, 1002

Digestive Diseases Centre GASTRO

Riga, Latvia, 1006

Mexico

Medical and Nutritional Trials

Cuauhtemoc, Cdmx, Mexico, 06700

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

Mexico, Distrito Federal, Mexico, 11650

Centro de Atención e Investigación en Factores de Riesgo Car

Mexico, Distrito Federal, Mexico, 14000

Clinicos Asociados BOCM SC

Portales, Distrito Federal, Mexico, 03300

Unidad de Investigacion Clinica Cardiometabolica de Occidente

Guadalajara, Jalisco, Mexico, 44150

Consultorio Medico

Guadalajara, Jalisco, Mexico, C.P. 44210

Unidad de Investigación Clínica en Medicina S.C.

Guadalajara, Jalisco, Mexico, C.P. 44670

Centro de Desarrollo Biomedico S.C.P.

Mérida, Yucatan, Mexico, 97070

Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV

Aguascalientes, Mexico, 20230

Hospital Cardiologica Aguascalientes

Aguascalientes, Mexico, 20230

Dioderm Instituto de Investigacion

Durango, Mexico, 34060

Sociedad de Metabolismo y Corazon, S.C.

Veracruz, Mexico, C.P. 91900

Russian Federation

Saint-Petersburg City Pokrovskaya Hospital

St-Petersburg, Leningrad Region, Russian Federation, 199106

Scientific Institute of Clinical and Experimental Lymphology

Novosibirsk, Novosibirsk Oblast, Russian Federation, 630117

GUZ Saratov City Clinical Hospital 9

Saratov, Saratov Region, Russian Federation, 410030

Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko

Nizhny Novgorod, Volga, Russian Federation, 603126

Kazan State Medical University

Kazan, Russian Federation, 420012

FSBI National medical endocrinology research centre

Moscow, Russian Federation, 117036

Moscow Regional Research Clinical Institute named by MF Vladimirski

Moscow, Russian Federation, 129110

Rostov on Don

Rostov on Don, Russian Federation, 344019

Rostov State Medical University

Rostov-on-Don, Russian Federation, 344022

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

Saint-Petersburg, Russian Federation, 191015

Saratov City Clinical Hospital 12

Saratov, Russian Federation, 410039

South Africa

FARMOVS

Bloemfontein, Free State, South Africa, 9301

Wits Clinical Research

Johannesburg, Gauteng, South Africa, 2193

Synexus Stanza Clinical Research Centre

Pretoria, Gauteng, South Africa, 0122

Watermeyer Clinical Research Site

Silverton, Gauteng, South Africa, 184

Synexus Helderberg Clinical Research Centre

Cape Town, Western Cape, South Africa, 7130

TREAD Research

Cape Town, South Africa, 7500

United Kingdom

MAC Clinical Research Manchester

Manchester, Greater Manchester, United Kingdom, M13 9NQ

Synexus Lancashire Dedicated Research Centre

Chorley, Lancashire, United Kingdom, PR7 7NA

Royal Oldham Hospital

Oldham, Lancashire, United Kingdom, OL1 2JH

MAC Research, Exchange House

Cannock, Staffordshire, United Kingdom, WS11 0BH

University Hospitals of North Midlands

Stoke on Trent, Staffordshire, United Kingdom, ST6 8DG

Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, United Kingdom, WV10 0QP

MAC Clinical Research, Monarch House

Leeds, West Yorkshire, United Kingdom, LS10 1DU

MAC Research

Barnsley, United Kingdom, S75 3DL

MAC Clinical Research

Blackpool, United Kingdom, FY2 0JH

Synexus Wales Clinical Research Centre

Cardiff, United Kingdom, CF15 9SS

Mid Essex Hospital Services NHS Trust Broomfield Hospital

Chelmsford, United Kingdom, CM1 7ET

Western General Hospital

Edinburgh, United Kingdom, EH4 2XU

Synexus Merseyside Dedicated Research Centre

Liverpool, United Kingdom, L22 0LG

MAC Clinical Research

Liverpool, United Kingdom, L34 1BH

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

London, United Kingdom, E1 2AJ

MAC Clinical Research, GAC House

Manchester, United Kingdom, M13 9NQ

Synexus Manchester Clinical Research Centre

Manchester, United Kingdom, M15 6SX

Royal Victoria Infirmary: Clinical Research Facility

Newcastle upon Tyne, United Kingdom, NE7 7DN

Biomedical Research Centre

Nottingham, United Kingdom, NG7 2UH

Synexus Hexham Dedicated Research Centre

Stockton-on-Tees, United Kingdom, TS19 8PE

Synexus North Tees Clinical Research Centre

Stockton-on-Tees, United Kingdom, TS19 8PE

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Wieslaw (Wes) Bochenek, MD, PhD; Allergan

  Study Documents (Full-Text)

Documents provided by Allergan:

Study Protocol  [PDF] March 5, 2019

Statistical Analysis Plan  [PDF] November 17, 2020

More Information

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT03426345
• Other Study ID Numbers: RLM-MD-02; 2017-002177-20 ( EudraCT Number )
• First Posted: February 8, 2018
• Results First Posted: August 6, 2021
• Last Update Posted: August 6, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Gastroparesis; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations