A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

Diabetes Mellitus Clinical Trial

Official title:

A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03420781
• Other study ID #: RLM-MD-03
• Status: Terminated
• Phase: Phase 3
• Start date: January 24, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2021
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 467
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants are eligible to be included in the study only if all the following

criteria apply:

• Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
• Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
• In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02

Exclusion Criteria:

• Participants are excluded from the study if any of the following criteria apply:
• Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
• Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
• Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
• Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease

Related Conditions & MeSH terms

• Diabetes Mellitus
• Gastroparesis

Intervention

Drug:
• Placebo
Placebo injected twice daily
• Relamorelin
Relamorelin 10 µg injected twice daily

Locations

Country	Name	City	State
Argentina	Maffei Centro Medico-Investigacion Clinica Aplicada	C.a.b.a.	Buenos Aires Province
Argentina	Hospital Sirio Libanes	Caba	Buenos Aires Province
Argentina	CIPREC	Ciudad Autonoma de Buenos Aires
Argentina	Instituto Privado de Investigaciones Clínicas de Córdoba	Córdoba	Cordoba
Argentina	Centro Universitario de Investigacion en Farmacologia Clinic	Corrientes
Argentina	Centro de Investigaciones Medicas Mar del Plata	Mar del Plata	Buenos Aires Province
Argentina	Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli	Rosario	Santa Fe
Argentina	Instituto de Investigaciones Clinicas de Rosario	Rosario	Santa Fe
Argentina	Clinica Mayo de Urgencias Medicas Cruz Blanca SRL	San Miguel de Tucuman	Tucuman
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Austria	VIVIT Institute, am LKH Feldkirch	Feldkirch'	Vorarlberg
Austria	Privatklinik Wehrle-Diakonissen	Salzburg
Austria	Ordination	Sankt Stefan ob Stainz	Styria
Austria	Landeskrankenhaus Steyr	Steyr
Belgium	AZ Sint Lucas Brugge	Brugge	West-Vlaanderen
Belgium	Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,	Edegem	Antwerp
Belgium	UZ Brussel	Jette	Brussel
Brazil	Hospital Universitário João de Barros Barreto	Belém
Brazil	Centro de Pesquisa Clinica do Brasil	Brasilia	Distrito Federal
Brazil	Instituto de Pesquisa Clinica de Campinas	Campinas	Sao Paulo
Brazil	Scentryphar Pesquisa Clinica Ltda	Campinas	Sao Paulo
Brazil	Hospital Universitário Walter Cantídio	Fortaleza	Ceara
Brazil	Instituto de Estudos e Pesquisas Clinicas do Ceará IEP/CE - Oncology	Fortaleza	Ceará
Brazil	Instituto Catarinense de Endocrinologia e Diabetes (ICED)	Joinville	Santa Catarina
Brazil	Núcleo de Pesquisa Clínica do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	CPQuali Pesquisa Clinica Ltda	Santa Cecília	São Paulo
Brazil	IPEC-Instituto de Pesquisa Clinica	Sao Paulo
Bulgaria	MHAT Yuliya Vrevska Byala	Byala	Ruse
Bulgaria	UMHAT - Kaspela- EOOD	Plovdiv
Canada	South Shore Medical Arts	Bridgewater	Nova Scotia
Canada	University of Calgary	Calgary	Alberta
Canada	Alberta Diabetes Institute	Edmonton	Alberta
Canada	Recherche GCP Research	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Central Alberta Research Centre	Red Deer	Alberta
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Toronto Digestive Disease Associates	Vaughan	Ontario
Colombia	Centro Cardiovascular y de Diabetes	Barranquilla	Atlantico
Colombia	Fundacion BIOS	Barranquilla	Atlantico
Colombia	Medplus Medicina Prepagada	Bogota	Distrito Capital De Bogota
Colombia	Endocare Ltda.	Bogotá	Cundinamarca
Colombia	Centro Medico Imbanaco de Cali S.A.	Cali	Valle Del Cauca
Colombia	IPS Centro Medico Julian Coronel S.A	Cali	Valle Del Cauca
Colombia	Centro Cardiovascular Colombiano Clínica Santa María	Medellin	Antioquia
Colombia	Rodrigo Botero S.A.S.	Medellín	Antioquia
Colombia	Fundacion Centro de Investigaciones Clinicas CARDIOMET	Pereira	Risaralda
Colombia	Asociación Colombiana de Diabetes	Teusaquillo	Distrito Capital De Bogotá
Colombia	Healthy Medical Center	Zipaquirá	Cundinamarca
Denmark	Gentofte Hospital	Hellerup	Copenhagen
Denmark	Gastroenheden, Hvidovre hospital	Hvidovre	Copenhagen
Germany	Studienzentrum Schwittay	Böhlen	Saxony
Germany	Klinische Forschung Dresden GmbH	Dresden	Saxony
Germany	Clinical Research Hamburg	Hamburg
Germany	Israelitisches Krankenhaus	Hamburg
Germany	KRH Klinikum Siloah	Hannover
Germany	Klinische Forschung Karlsruhe GmbH	Karlsruhe	Baden-Wuertemberg
Hungary	Strázsahegy Gyógyszertár Medicina	Budapest
Hungary	Synexus Budapest DRS	Budapest
Hungary	Markhot Ferenc Oktatokorhaz es Rendelointezet	Eger	Heves
Hungary	First Department of Medicine, University of Szeged	Szeged	Csonfrád
Hungary	Hetenyi Geza Hospital	Tószeg	Jász-Nagykun-Szolnok
Hungary	Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Zala
India	Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre	Ahmedabad	Gujarat
India	Life Care Hospital & Research Centre	Bangalore	Karnataka
India	Victoria Hospital	Bangalore	Karnataka
India	Diacon Hospital and research Center - Diabetology	Bengaluru	Karnataka
India	Rajalakshmi Hospital	Bengaluru	Karnataka
India	Kovai Diabetes Speciality Centre	Coimbatore	Tamil Nadu
India	Kumudini Devi Diabetes Research Center; Ramdevrao Hospital	Hyderabad	Andhra Pradesh
India	Diabetic Thyroid and Endocrine Centre	Jaipur	Rajasthan
India	Eternal Hospital - Diabetology	Jaipur	Rajasthan
India	Marudhar Hospital	Jaipur	Rajasthan
India	S.R. Kalla (SRK) Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	SMS Hospital	Jaipur	Rajasthan
India	M. V Hospital & Research Centre	Lucknow	Uttar Prandesh
India	Arthur Asirvatham Hospital	Madurai	Tamil Nadu
India	Vinaya Hospital & Research Centre	Mangalore	Karnataka
India	Bhatia Hospital	Mumbai	Maharashtra
India	Sir Ganga Ram Hospital	New Delhi
India	B. J. Government Medical College and Sassoon General Hospitals	Pune	Maharashtra
India	Noble Hospital	Pune	Maharashtra
India	Universal Hospital	Pune	Maharashtra
India	King George Hospital	Visakhapatnam	Andhra Pradesh
Israel	Bnai Zion Medical Center	Haifa
Israel	Endocrinology & Diabetes Center	Safed
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeollabuk-Do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Diabetes Center	Seoul	Nowon-gu
Latvia	Polana-D	Daugavpils
Latvia	Kraslava Hospital	Kraslava	Kraslavas Nov.
Latvia	Digestive Diseases Centre GASTRO	Riga
Latvia	Pauls Stradins Clinical University Hospital, Endokrinologijas nodala	Riga
Malaysia	Hospital Sultanah Bahiyah	Alor Setar	Kedah
Malaysia	Universiti Sains Malaysia	Kubang Kerian
Malaysia	Hospital Taiping	Taiping
Mexico	Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV	Aguascalientes
Mexico	Hospital Cardiologica Aguascalientes	Aguascalientes
Mexico	Mentrials SA DE CV	Cuauhtemoc	Cdmx
Mexico	Centro de Investigación y Atención de Diabetes - Endocrinología y Nutrición	Durango	Guillermina
Mexico	Dioderm Instituto de Investigacion	Durango
Mexico	Consultorio Medico	Guadalajara	Jalisco
Mexico	Unidad de Investigacion Clinica Cardiometabolica de Occidente, S.C.	Guadalajara	Jalisco
Mexico	Unidad de Investigación Clínica en Medicina S.C.	Guadalajara	Jalisco
Mexico	Centro de Desarrollo Biomédico S.C.P	Mérida	Yucatán
Mexico	Centro de Atención e Investigación en Factores de Riesgo Car	Mexico	Mexico DF
Mexico	Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology	Mexico	Distrito Federal
Mexico	Clinicos Asociados BOCM SC	Mexico	Distrito Federal
Mexico	Sociedad de Metabolismo y Corazon, S.C.	Veracruz
Philippines	Perpetual Succor Hospital	Cebu City
Philippines	West Visayas State University Medical Center	IloIlo City	IloIlo
Philippines	Ospital ng Makati	Makati City	NCR
Philippines	Manila Doctors Hospital, Ermita	Manila	Metropolitan Manila
Philippines	San Juan De Dios Educational Foundation, Inc.	Pasay	Metropolitan Manila
Philippines	St. Luke's Medical Center	Quezon City	Metro Manila
Philippines	Cardinal Santos Medical Center	San Juan City	Metro Manila
Poland	NZOZ Vita Diabetica - Malgorzata Buraczyk	Bialystok	Podlaski
Poland	Centrum Medyczne Lukamed	Chojnice
Poland	Specjalistyczny Gabinet Neurologiczny Marta Banach	Krakow
Poland	Endoskopia Sp. Z O.O.	Sopot	Pomorskie
Poland	Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska	Wroclaw
Russian Federation	Kazan State Medical University	Kazan
Russian Federation	FSBI National medical endocrinology research centre	Moscow
Russian Federation	Moscow Regional Research Clinical Institute named by MF Vladimirski	Moscow
Russian Federation	Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko	Nizhny Novgorod	Volga
Russian Federation	Scientific Institute of Clinical and Experimental Lymphology	Novosibirsk	Novosibirskaya Oblast
Russian Federation	Rostov on Don	Rostov on Don
Russian Federation	Rostov State Medical University	Rostov-on-Don
Russian Federation	North-Western State Medical University named after I. I. Mechnikov	Saint-Petersburg	Sankt-Peterburg
Russian Federation	GUZ Saratov City Clinical Hospital 9	Saratov
Russian Federation	Saratov City Clinical Hospital 12	Saratov
Russian Federation	Saint-Petersburg City Pokrovskaya Hospital	St-Petersburg	Leningrad Region
Singapore	Changi General Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
South Africa	FARMOVS	Bloemfontein	Free State
South Africa	Synexus Helderberg Clinical Research Centre	Cape Town	Western Cape
South Africa	Wits Clinical Research	Johannesburg	Gauteng
South Africa	Synexus Stanza Clincal Reaserch Centre	Pretoria	Gauteng
South Africa	Watermeyer Clinical Research Site	Pretoria	Gauteng
Thailand	Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai
Ukraine	Regional muniRegional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious	Chernivtsi
Ukraine	Regional Public Organization "Chernivtsi Regional Endocrinology Center"	Chernivtsi
Ukraine	State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine	Dnipro
Ukraine	Ivano-Frankivsk Central City Clinical Hospital	Ivano-Frankivsk	Ivano-Frankivsk Oblast
Ukraine	Ivano-Frankivsk National Medical University	Ivano-Frankivsk	Ivano-Frankivsk Oblast
Ukraine	Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"	Kharkiv
Ukraine	L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine	Kharkiv
Ukraine	Municipal nonprofit entity of Kharkiv municipal council	Kharkiv
Ukraine	Communal Institution Kherson City Clinical Hospital	Kherson
Ukraine	Kyiv clinical hospital on railway transport #2 of the "Healthcare Centre" branch of JSC "Ukrainian Railway"	Kyiv
Ukraine	Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv	Kyiv
Ukraine	Medical Center Universal Clinic Oberig	Kyiv
Ukraine	Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit	Kyiv
Ukraine	Communal Institution "Odesa Regional Clinical Hospital", Out-patient department	Odesa
Ukraine	Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University	Odesa
Ukraine	Poltava Regional Clinical Hospital	Poltava
Ukraine	Ternopil University Hospital	Ternopil
Ukraine	Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia	Vinnytsia
Ukraine	Private Small-Scale Enterprise Medical Centre Pulse	Vinnytsia
Ukraine	Vinnytsia Regional Clinical highly specialized Endocrinology Centre	Vinnytsia
Ukraine	6th City Clinical Hospital, c. Zaporizhzhia	Zaporizhzhia
Ukraine	Municipal Institution, City Hospital #7	Zaporizhzhia
United Kingdom	MAC Research	Barnsley
United Kingdom	MAC Clinical Research, Kaman Court	Blackpool
United Kingdom	MAC Research, Exchange House	Cannock	Staffordshire
United Kingdom	Mid Essex Hospital Services NHS Trust Broomfield Hospital	Chelmsford
United Kingdom	MAC Clinical Research, Monarch House	Leeds	West Yorkshire
United Kingdom	MAC Clinical Research	Liverpool
United Kingdom	MAC Clinical Research Manchester	Manchester	Greater Manchester
United Kingdom	Biomedical Research Centre	Nottingham	East Midland
United Kingdom	Royal Oldham Hospital	Oldham	Lancashire
United Kingdom	MAC Clinical Research, GAC House	Stockton-on-Tees
United States	Lovelace Scientific Resources, Inc.	Albuquerque	New Mexico
United States	Synexus Clinical Research US, Inc	Anderson	South Carolina
United States	Synexus Clinical Research US, Inc.	Anderson	South Carolina
United States	Texas Clinical Research Institute, LLC	Arlington	Texas
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	North Alabama Research Center, LLC	Athens	Alabama
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	Avant Research Associates,LLC	Austin	Texas
United States	Delta Research Partners	Bastrop	Louisiana
United States	Dayton Gastroenterology, Inc.	Beavercreek	Ohio
United States	River Birch Research Alliance, LLC	Blue Ridge	Georgia
United States	WK Physicians Network	Bossier City	Louisiana
United States	Trialspark - Silverman	Bowie	Maryland
United States	Garden State Endocrinology	Brick	New Jersey
United States	Gastroenterology Associates of Fairfield County, P.C.	Bridgeport	Connecticut
United States	Commonwealth Clinical Studies, PLLC.	Brockton	Massachusetts
United States	Gwinnett Research Institute, LLC	Buford	Georgia
United States	Hope Clinical Research	Canoga Park	California
United States	Diabetes & Endocrinology Associates of Stark County, Inc.	Canton	Ohio
United States	Summit Clinical Research, LLC.	Carnesville	Georgia
United States	ClinRx Research, LLC	Carrollton	Texas
United States	Del Sol Research Management, LLC	Chandler	Arizona
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Clinsearch	Chattanooga	Tennessee
United States	Clinical Research Institute of Michigan	Chesterfield	Michigan
United States	GW Research Inc	Chula Vista	California
United States	Synexus Clinical Research US - Cincinnati	Cincinnati	Ohio
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Innovative Research of West FL, Inc.	Clearwater	Florida
United States	West Central Gastroenterology	Clearwater	Florida
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Synexus Clinical Research US, Inc. - Colorado Springs Family Practice	Colorado Springs	Colorado
United States	Gastro Center of Maryland	Columbia	Maryland
United States	Aventiv Research, Inc.	Columbus	Ohio
United States	Endocrinology Research Associates, Inc.	Columbus	Ohio
United States	Hometown Urgent Care and Research	Columbus	Ohio
United States	The Ohio State University, Wexner Medical Center	Columbus	Ohio
United States	Carolina Digestive Health Associates, PA	Concord	North Carolina
United States	Minnesota Gastroenterology, P.A.	Coon Rapids	Minnesota
United States	ALL Medical Research LLC	Cooper City	Florida
United States	Kindred Medical Institute for Clinical Trials, LLC	Corona	California
United States	Aurora Care Clinic, LLC	Costa Mesa	California
United States	Tri-State Gastroenterology	Crestview Hills	Kentucky
United States	Avant Research Associates LLC	Crowley	Louisiana
United States	Top Medical Research	Cutler Bay	Florida
United States	Synexus Clinical Research US, Inc.	Dallas	Texas
United States	CIC America Clinical Inquest Center Ltd.	Dayton	Ohio
United States	Hometown Urgent Care and Research	Dayton	Ohio
United States	Vida Clinical Studies	Dearborn	Michigan
United States	iResearch Atlanta LLC	Decatur	Georgia
United States	Digestive Health Specialist of the South East	Dothan	Alabama
United States	AGA Clinical Research Associates LLC	Egg Harbor Township	New Jersey
United States	Diagnamics Inc.	Encinitas	California
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Verity Research Inc.	Fairfax	Virginia
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Aa Mrc Llc	Flint	Michigan
United States	G & L Research, LLC	Foley	Alabama
United States	Premier Clinical Research d.b.a. STAT Research	Franklin	Ohio
United States	Frederick Gastroenterology Associates, PA an Elligo Health Research Site	Frederick	Maryland
United States	VVCRD Research	Garden Grove	California
United States	Gastro One	Germantown	Tennessee
United States	Woodholme Gastroenterology Associates, P.A.	Glen Burnie	Maryland
United States	Long Island Gastrointestinal Research Group LLP	Great Neck	New York
United States	Triad Clinical Trials	Greensboro	North Carolina
United States	Gastroenterology Associates, PA	Greenville	South Carolina
United States	National Clinical, LLC	Hamtramck	Michigan
United States	Palmetto Research, LLC	Hialeah	Florida
United States	Vida Clinical Trials	Homestead	Florida
United States	Cronola LLC	Houma	Louisiana
United States	Amir Ali Hassan, MD, PA	Houston	Texas
United States	Biopharma Informatic Inc., Research Center	Houston	Texas
United States	Rodriguez Clinical Trials	Houston	Texas
United States	Rocky Mountain Diabetes and Osteoporosis Center, PA	Idaho Falls	Idaho
United States	Nature Coast Clinical Research	Inverness	Florida
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Synexus Clinical Research US, Inc.	Jamaica	New York
United States	American Research, LLC	Jeffersonville	Indiana
United States	United Health Services Hospitals, Inc.	Johnson City	New York
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Sante Clinical Research	Kerrville	Texas
United States	Vidant Multispeciality Clinic - Kinston	Kinston	North Carolina
United States	University of California San Diego	La Jolla	California
United States	Clinical Trials of SWLA, LLC	Lake Charles	Louisiana
United States	Om Research LLC	Lancaster	California
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Clinical Research of South Nevada	Las Vegas	Nevada
United States	Digestive Disease Specialists	Las Vegas	Nevada
United States	Excel Clinical Research	Las Vegas	Nevada
United States	Palm Research Center	Las Vegas	Nevada
United States	Family Medical Associates, Research Department	Levittown	Pennsylvania
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Preferred Research Partners, Inc.	Little Rock	Arkansas
United States	Torrance Clinical Research Institute, Inc.	Lomita	California
United States	Angel City Research Inc.	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Manassas Clinical Research Centre	Manassas	Virginia
United States	Tandem Clinical Research	Marrero	Louisiana
United States	New Orleans Research Institute - Metropolitan Gastroenterology Associates	Metairie	Louisiana
United States	Advanced Medical Research Institute	Miami	Florida
United States	American Research Institute, Inc	Miami	Florida
United States	AMPM Research Clinic	Miami	Florida
United States	APF Research LLC	Miami	Florida
United States	Florida Research Center, Inc.	Miami	Florida
United States	Panax Clinical Research, LLC.	Miami Lakes	Florida
United States	Savin Medical Group LLC	Miami Lakes	Florida
United States	Montana Medical Research	Missoula	Montana
United States	Alabama Medical Group, PC	Mobile	Alabama
United States	Diabetes and Endocrinology Consultants, PC	Morehead City	North Carolina
United States	West Virginia University	Morgantown	West Virginia
United States	Quality Medical Research	Nashville	Tennessee
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	Southwest Gastroenterology	Oak Lawn	Illinois
United States	Advanced Research Institute, Inc.	Ogden	Utah
United States	Digestive Disease Specialists Inc	Oklahoma City	Oklahoma
United States	Memorial Clinical Research	Oklahoma City	Oklahoma
United States	Heartland Clinical Research, Inc	Omaha	Nebraska
United States	Methodist Physicians Clinic Diabetes and Endocrine Specialists	Omaha	Nebraska
United States	Phoenix Clinical LLC.	Phoenix	Arizona
United States	Synexus	Pinellas Park	Florida
United States	Allegheny Endocrinology Associates	Pittsburgh	Pennsylvania
United States	Preferred Primary Care Physicians, Inc.	Pittsburgh	Pennsylvania
United States	Northwest Gastroenterology Clinic, LLC	Portland	Oregon
United States	TriWest Research Associates	Poway	California
United States	Health Science Research Center	Pratt	Kansas
United States	Health Concepts	Rapid City	South Dakota
United States	Infinite Clinical Trials	Riverdale	Georgia
United States	Meridian Clinical Research, LLC	Rockville	Maryland
United States	PMG Research Salisbury	Salisbury	North Carolina
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Pinnacle Clinical Research	San Antonio	Texas
United States	Southern Star Research Institute, LLC	San Antonio	Texas
United States	Synexus Clinical Research US, Inc.	San Antonio	Texas
United States	Medical Associates Research Group, Inc	San Diego	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	Unity Health - Searcy Medical Center	Searcy	Arkansas
United States	WestGlen Gastrointestinal Consultants	Shawnee Mission	Kansas
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	Montgomery Medical, Inc.	Smithfield	Pennsylvania
United States	Clinical Research Consultants of Atlanta	Suwanee	Georgia
United States	Washington Gastroenterology PLLC	Tacoma	Washington
United States	Cotton-O'Neil Clinical Research Center - Digestive Health	Topeka	Kansas
United States	Kansas Medical Clinic	Topeka	Kansas
United States	Del Sol Research Management, LLC	Tucson	Arizona
United States	Options Health Research, LLC	Tulsa	Oklahoma
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Upland Clinical Research	Upland	California
United States	Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research	Wadsworth	Ohio
United States	TrialSpark, Inc.	Washington	District of Columbia
United States	Advanced Clinical Research	West Jordan	Utah
United States	Clinical Trials of America, Inc.	West Monroe	Louisiana
United States	Professional Research Network of Kansas, LLC	Wichita	Kansas
United States	Via Christi Clinic, PA	Wichita	Kansas
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	Trial Management Associates, LLC	Wilmington	North Carolina
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	Cardinal Internal Medicine Associates, PC	Woodbridge	Virginia
United States	Gastroenterology Associates of Western Michigan	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Colombia,  Denmark,  Germany,  Hungary,  India,  Israel,  Korea, Republic of,  Latvia,  Malaysia,  Mexico,  Philippines,  Poland,  Russian Federation,  Singapore,  South Africa,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period	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 in the previous studies.	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study
Primary	Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the 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 first 12-weeks of the 40-week Treatment Period.	Week 6 to Week 12
Secondary	Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the 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 first 12-weeks of the 40-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. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Secondary	Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the 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 first 12-weeks of the 40-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. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Secondary	Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the 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 first 12-weeks of the 40-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. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Secondary	Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the 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 first 12-weeks of the 40-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). Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Secondary	Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period	Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages (Week 37 to Week 40) 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 of the previous studies.	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
Secondary	Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the 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 the last 4 weeks of the 40-week Treatment Period.	Week 37 to Week 40
Secondary	Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the 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. The average weekly number of vomiting episodes were derived as the average of the weekly number of vomiting episodes in the last 4 weeks of the 40-week Treatment Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
Secondary	Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period	Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an 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). Average weekly scores are derived as the average of the weekly scores from the 6 weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
Secondary	Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal 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. Average weekly number of vomiting episodes are derived as the average of the weekly number of vomiting episodes from the six weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.	Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
Secondary	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.	First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks)
Secondary	Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results	Clinical Laboratory values 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.	Up to 46 weeks
Secondary	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 results were clinically significant.	Up to 46 weeks
Secondary	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.	Up to 46 weeks
Secondary	Number of Participants With a =1% Increase in Glycosylated Hemoglobin A1c (HBA1c)		Up to 46 weeks
Secondary	Number of Participants With Anti-relamorelin Antibody Testing Results	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.	Up to 46 weeks