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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03426345
Recruitment Status : Terminated (The Relamorelin program is being terminated solely based on a business decision)
First Posted : February 8, 2018
Results First Posted : August 6, 2021
Last Update Posted : August 6, 2021
Information provided by (Responsible Party):

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

Layout table for study information
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

Resource links provided by the National Library of Medicine

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.

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426345

Hide Hide 240 study locations
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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
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
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
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
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
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
AZ Sint Lucas Brugge
Brugge, Antwerpen, Belgium, 2650
Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
Edegem, Antwerp, Belgium, 2650
UZ Brussel
Jette, Brussel, Belgium, 1090
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
Central Alberta Research Centre
Red Deer, Canada, T4N 6V7
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
Gastroenheden, Hvidovre hospital
Hvidovre, Copenhagen, Denmark, 2605
Endocrinology, Aalborg University Hospital
Aalborg, Denmark, DK-9000
Center for Clinical Metabolic Research
Hellerup, Denmark, 2900
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
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
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
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
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
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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

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03426345    
Other Study ID Numbers: RLM-MD-02
2017-002177-20 ( EudraCT Number )
First Posted: February 8, 2018    Key Record Dates
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations