Clinical trial NCT03426345: Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastroparesis
Diabetes Mellitus
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-02-08
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
timeFrame: Baseline (Day-14 to Day-1) to Week 12
measure: Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
timeFrame: Week 6 to Week 12
Secondary outcomes:
measure: Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
timeFrame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
measure: Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
timeFrame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
measure: Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
timeFrame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
measure: Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
timeFrame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
measure: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
timeFrame: Up to approximately 16 weeks
measure: Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
timeFrame: Up to 12 weeks
measure: Number of Participants With Clinically Meaningful Trends for Vital Signs
timeFrame: Up to 12 weeks
measure: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
timeFrame: Up to 12 weeks
measure: Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
timeFrame: Baseline (Day 1) up to 12 weeks
measure: Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
timeFrame: Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center, LLC
state: Alabama
city: Birmingham
country: United States
facility: Synexus Clinical Research US - Simon Williamson Clinic
state: Alabama
city: Foley
country: United States
facility: G & L Research, LLC
state: Alabama
city: Mobile
country: United States
facility: Alabama Medical Group, PC
state: Alabama
city: Tucson
country: United States
facility: Synexus Clinical Research US, Inc.
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Searcy
country: United States
facility: Unity Health - Searcy Medical Center
state: Arkansas
city: Chula Vista
country: United States
facility: GW Research Inc.
state: California
city: Encinitas
country: United States
facility: Diagnamics Inc.
state: California
city: Fresno
country: United States
facility: Fresno Clinical Research Center
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute, Inc.
state: California
city: Long Beach
country: United States
facility: Tibor Rubin VA Medical Center
state: California
city: Los Angeles
country: United States
facility: Angel City Research Inc.
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Palo Alto
country: United States
facility: Stanford Hospital, Digestive Health Clinic
state: California
city: Poway
country: United States
facility: TriWest Research Associates
state: California
city: San Diego
country: United States
facility: Optimal Research California
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Whittier
country: United States
facility: New Hope Research Development
state: California
city: Colorado Springs
country: United States
facility: Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
state: Colorado
city: Bridgeport
country: United States
facility: Gastroenterology Associates of Fairfield County, P.C.
state: Connecticut
city: Aventura
country: United States
facility: Visionary Investigators Network
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Cooper City
country: United States
facility: ALL Medical Research LLC
state: Florida
city: Hialeah
country: United States
facility: Palmetto Research, LLC
state: Florida
city: Homestead
country: United States
facility: Vida Clinical Trials
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research, Inc.
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Pinellas Park
country: United States
facility: Synexus
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida - Weston
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, LLC
state: Georgia
city: Buford
country: United States
facility: Gwinnett Research Institute, LLC
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta LLC
state: Georgia
city: Suwanee
country: United States
facility: Clinical Research Consultants of Atlanta
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center, PA
state: Idaho
city: Chicago
country: United States
facility: Synexus Clinical Research US, Inc.
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
city: Jeffersonville
country: United States
facility: American Research, LLC
state: Indiana
city: New Albany
country: United States
facility: Gastroenterology of Southern Indiana
state: Indiana
city: Pratt
country: United States
facility: Health Science Research Center
state: Kansas
city: Shawnee Mission
country: United States
facility: WestGlen Gastrointestinal Consultants
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic
state: Kansas
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: Wichita
country: United States
facility: Via Christi Clinic, PA
state: Kansas
city: Crestview Hills
country: United States
facility: Tri-State Gastroenterology
state: Kentucky
city: Bossier City
country: United States
facility: WK Physicians Network
state: Louisiana
city: Crowley
country: United States
facility: Avant Research Associates LLC
state: Louisiana
city: Lake Charles
country: United States
facility: Clinical Trials of SWLA, LLC
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: West Monroe
country: United States
facility: Clinical Trials of America, Inc.
state: Louisiana
city: Bowie
country: United States
facility: Trialspark - Sood
state: Maryland
city: Camp Springs
country: United States
facility: Capital Diabetes and Endocrine Associates
state: Maryland
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
state: Maryland
city: Glen Burnie
country: United States
facility: Woodholme Gastroenterology Associates, P.A.
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Rockville
country: United States
facility: Meridian Clinical Research, LLC
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies, PLLC.
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Flint
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: Synexus Clinical Research US, Inc
state: Missouri
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc
state: Nebraska
city: Elizabeth
country: United States
facility: USMA Clinical Research, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources, Inc.
state: New Mexico
city: Jamaica
country: United States
facility: Synexus Clinical Research US, Inc.
state: New York
city: Mineola
country: United States
facility: Winthrop-University Hospital
state: New York
city: Davidson
country: United States
facility: Carolina Digestive Health Associates, PA
state: North Carolina
city: Kinston
country: United States
facility: Kinston Medical Specialists, P.A.
state: North Carolina
city: Morehead City
country: United States
facility: Diabetes and Endocrinology Consultants, PC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Akron
country: United States
facility: Synexus Clinical Research US, Inc.
state: Ohio
city: Canton
country: United States
facility: Diabetes & Endocrinology Associates of Stark County, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Clinical Research US - Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Clinical Research US, Inc
state: Ohio
city: Cleveland
country: United States
facility: The MetroHealth System MHS
state: Ohio
city: Cleveland
country: United States
facility: Digestive Disease & Surgery Institute
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University, Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: CIC America Clinical Inquest Center Ltd.
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Oklahoma City
country: United States
facility: Centennial Health-Synexus
state: Oklahoma
city: Tulsa
country: United States
facility: Options Health Research, LLC
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Endocrinology Associates
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Clinical Research
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Warwick
country: United States
facility: Care Access Research
state: Rhode Island
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc.
state: South Carolina
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Chattanooga
country: United States
facility: Clinsearch
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Johnson City
country: United States
facility: East Tennessee Research Institute
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Carrollton
country: United States
facility: ClinRx Research, LLC
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Medical Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Inc., Research Center
state: Texas
city: Houston
country: United States
facility: Houston Endoscopy and Research Center, Inc.
state: Texas
city: Houston
country: United States
facility: Rodriguez Clinical Trials
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Synexus Clinical Research US, Inc.
state: Texas
city: San Antonio
country: United States
facility: Digestive & Liver Disease Center of San Antonio, PLLC
state: Texas
city: Sugar Land
country: United States
facility: Dwayne O. Williams MD
state: Texas
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Centre
state: Virginia
city: Richmond
country: United States
facility: VA Medical Center McGuire VAMC
state: Virginia
city: Tacoma
country: United States
facility: Washington Gastroenterology PLLC
state: Washington
city: C.a.b.a.
country: Argentina
facility: Maffei Centro Medico-Investigacion Clinica Aplicada
state: Buenos Aires Province
city: Caba
country: Argentina
facility: Hospital Sirio Libanes
state: Buenos Aires Province
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata SRL
state: Buenos Aires Province
city: Córdoba
country: Argentina
facility: Instituto Privado de Investigaciones Clínicas de Córdoba
state: Cordoba
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas de Rosario
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo - Infectious DiseasesClínica Mayo de Urgencias
state: Tucuman
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CIPREC
city: Corrientes
country: Argentina
facility: Centro Universitario de Investigacion en Farmacologia Clinic
city: Córdoba
country: Argentina
facility: CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian
city: Sankt Stefan
country: Austria
facility: Ordination
state: Steiermark
city: Feldkirch
country: Austria
facility: VIVIT Institute, am LKH Feldkirch
state: Vorarlberg
city: Salzburg
country: Austria
facility: Privatklinik Wehrle-Diakonissen
city: Steyr
country: Austria
facility: Oö. Gesundheits- und Spitals-AG/LKH Steyr
city: Brugge
country: Belgium
facility: AZ Sint Lucas Brugge
state: Antwerpen
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
state: Antwerp
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
city: Fortaleza
country: Brazil
facility: Hospital Universitario Walter Cantidio
state: Ceara
city: Brasilia
country: Brazil
facility: Centro de Pesquisa Clinica do Brasil
state: Distrito Federal
city: Belem
country: Brazil
facility: Hospital Universitario Joao de Barros Barreto
state: Para
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Instituto Catarinense de Endocrinologia e Diabetes (ICED)
state: Santa Catarina
city: Campinas
country: Brazil
facility: Scentryphar Pesquisa Clinica Ltda
state: Sao Paulo
city: Campinas
country: Brazil
facility: Instituto de Pesquisa Clinica em Campinas
state: Sao Paulo
city: Santa Cecília
country: Brazil
facility: CPQuali Pesquisa Clinica Ltda
state: Sao Paulo
city: Fortaleza
country: Brazil
facility: Instituto de Estudos E Persquisas Clinicas do Ceará - IEP/CE - Oncology
city: SÃo Paulo
country: Brazil
facility: Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Diabetes Institute
state: Alberta
city: Vancouver
country: Canada
facility: Gordon and Leslie Diamond Health Care Centre
state: British Columbia
city: St. John's
country: Canada
facility: Eastern Health
state: Newfoundland and Labrador
city: Bridgewater
country: Canada
facility: South Shore Medical Arts
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie-Centre
state: Quebec
city: Montreal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal - CHUM
state: Quebec
city: Red Deer
country: Canada
facility: Central Alberta Research Centre
city: Medellin
country: Colombia
facility: Centro Cardiovascular Colombiano Clínica Santa María
state: Antioquia
city: Medellin
country: Colombia
facility: Rodrigo Botero S.A.S.
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro Cardiovascular y de Diabetes
state: Atlantico
city: Barranquilla
country: Colombia
facility: Fundacion Bios
state: Atlantico
city: Bogotá
country: Colombia
facility: Asociación Colombiana de Diabetes
state: Cundinamarca
city: Zipaquira
country: Colombia
facility: Healthy Medical Center
state: Cundinamarca
city: Bogota
country: Colombia
facility: Medplus Mp
state: Distrito Capital De Bogotá
city: Bogota
country: Colombia
facility: Endocare Ltda.
state: Distrito Capital De Bogotá
city: Pereira
country: Colombia
facility: Fundacion Centro de Investigaciones Clinicas CARDIOMET
state: Risaralda
city: Cali
country: Colombia
facility: IPS Centro Medico Julian Coronel S.A
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A.
state: Valle Del Cauca
city: Hvidovre
country: Denmark
facility: Gastroenheden, Hvidovre hospital
state: Copenhagen
city: Aalborg
country: Denmark
facility: Endocrinology, Aalborg University Hospital
city: Hellerup
country: Denmark
facility: Center for Clinical Metabolic Research
city: Karlsruhe
country: Germany
facility: Klinische Forschung Karlsruhe GmbH
state: Baden-SWÃƒÂ¼rttemberg
city: Böhlen
country: Germany
facility: Studienzentrum Schwittay
state: Saxony
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
state: Saxony
city: Giessen
country: Germany
facility: Clinical Research Unit
city: Hamburg
country: Germany
facility: Clinical Research Hamburg
city: Hamburg
country: Germany
facility: Israelitisches Krankenhaus
city: Hannover
country: Germany
facility: KRH Klinikum Siloah
city: Eger
country: Hungary
facility: Markhot Ferenc Oktatokorhaz es Rendelointezet
state: Heves
city: Hatvan
country: Hungary
facility: BKS Research Kft Synexus AS
state: Heves
city: Szolnok
country: Hungary
facility: Hetenyi Geza Hospital
state: Jász-Nagykun-Szolnok
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz
state: Zala
city: Budapest
country: Hungary
facility: Synexus Budapest DRS
city: Budapest
country: Hungary
facility: Strázsahegy Gyógyszertár Medicina
city: Debrecen
country: Hungary
facility: SYNEXUS Magyarorszag Kft Debrecen A.S.
city: Gyula
country: Hungary
facility: Synexus Magyarország kft. Gyula DRS
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
city: Zalaegerszeg
country: Hungary
facility: Synexus Magyarorszag Kft
city: Daugavpils
country: Latvia
facility: Polana-D
city: Kraslava
country: Latvia
facility: Kraslava Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
city: Riga
country: Latvia
facility: Digestive Diseases Centre GASTRO
city: Cuauhtemoc
country: Mexico
facility: Medical and Nutritional Trials
state: Cdmx
city: Mexico
country: Mexico
facility: Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology
state: Distrito Federal
city: Mexico
country: Mexico
facility: Centro de Atención e Investigación en Factores de Riesgo Car
state: Distrito Federal
city: Portales
country: Mexico
facility: Clinicos Asociados BOCM SC
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion Clinica Cardiometabolica de Occidente
state: Jalisco
city: Guadalajara
country: Mexico
facility: Consultorio Medico
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Clínica en Medicina S.C.
state: Jalisco
city: Mérida
country: Mexico
facility: Centro de Desarrollo Biomedico S.C.P.
state: Yucatan
city: Aguascalientes
country: Mexico
facility: Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
city: Aguascalientes
country: Mexico
facility: Hospital Cardiologica Aguascalientes
city: Durango
country: Mexico
facility: Dioderm Instituto de Investigacion
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon, S.C.
city: St-Petersburg
country: Russian Federation
facility: Saint-Petersburg City Pokrovskaya Hospital
state: Leningrad Region
city: Novosibirsk
country: Russian Federation
facility: Scientific Institute of Clinical and Experimental Lymphology
state: Novosibirsk Oblast
city: Saratov
country: Russian Federation
facility: GUZ Saratov City Clinical Hospital 9
state: Saratov Region
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko
state: Volga
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Moscow
country: Russian Federation
facility: FSBI National medical endocrinology research centre
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Clinical Institute named by MF Vladimirski
city: Rostov on Don
country: Russian Federation
facility: Rostov on Don
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint-Petersburg
country: Russian Federation
facility: North-Western State Medical University named after I. I. Mechnikov
city: Saratov
country: Russian Federation
facility: Saratov City Clinical Hospital 12
city: Bloemfontein
country: South Africa
facility: FARMOVS
state: Free State
city: Johannesburg
country: South Africa
facility: Wits Clinical Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Synexus Stanza Clinical Research Centre
state: Gauteng
city: Silverton
country: South Africa
facility: Watermeyer Clinical Research Site
state: Gauteng
city: Cape Town
country: South Africa
facility: Synexus Helderberg Clinical Research Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: TREAD Research
city: Manchester
country: United Kingdom
facility: MAC Clinical Research Manchester
state: Greater Manchester
city: Chorley
country: United Kingdom
facility: Synexus Lancashire Dedicated Research Centre
state: Lancashire
city: Oldham
country: United Kingdom
facility: Royal Oldham Hospital
state: Lancashire
city: Cannock
country: United Kingdom
facility: MAC Research, Exchange House
state: Staffordshire
city: Stoke on Trent
country: United Kingdom
facility: University Hospitals of North Midlands
state: Staffordshire
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton NHS Trust
state: West Midlands
city: Leeds
country: United Kingdom
facility: MAC Clinical Research, Monarch House
state: West Yorkshire
city: Barnsley
country: United Kingdom
facility: MAC Research
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research
city: Cardiff
country: United Kingdom
facility: Synexus Wales Clinical Research Centre
city: Chelmsford
country: United Kingdom
facility: Mid Essex Hospital Services NHS Trust Broomfield Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Liverpool
country: United Kingdom
facility: Synexus Merseyside Dedicated Research Centre
city: Liverpool
country: United Kingdom
facility: MAC Clinical Research
city: London
country: United Kingdom
facility: Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital
city: Manchester
country: United Kingdom
facility: MAC Clinical Research, GAC House
city: Manchester
country: United Kingdom
facility: Synexus Manchester Clinical Research Centre
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary: Clinical Research Facility
city: Nottingham
country: United Kingdom
facility: Biomedical Research Centre
city: Stockton-on-Tees
country: United Kingdom
facility: Synexus Hexham Dedicated Research Centre
city: Stockton-on-Tees
country: United Kingdom
facility: Synexus North Tees Clinical Research Centre
Study officials:
affiliation: Allergan
name: Wieslaw (Wes) Bochenek, MD, PhD
role: STUDY_DIRECTOR
References: