A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
Gastroparesis, Diabetes Mellitus
About this trial
This is an interventional treatment trial for Gastroparesis focused on measuring diabetic gastroparesis, vomiting
Eligibility Criteria
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
Sites / Locations
- North Alabama Research Center, LLC
- Digestive Health Specialist of the South East
- G & L Research, LLC
- Alabama Medical Group, PC
- Del Sol Research Management, LLC
- Phoenix Clinical LLC.
- Del Sol Research Management, LLC
- Preferred Research Partners, Inc.
- Applied Research Center of Arkansas
- Arkansas Gastroenterology
- Unity Health - Searcy Medical Center
- Hope Clinical Research
- GW Research Inc
- Kindred Medical Institute for Clinical Trials, LLC
- Aurora Care Clinic, LLC
- Diagnamics Inc.
- VVCRD Research
- University of California San Diego
- Om Research LLC
- Torrance Clinical Research Institute, Inc.
- Angel City Research Inc.
- TriWest Research Associates
- Medical Associates Research Group, Inc
- Syrentis Clinical Research
- Upland Clinical Research
- Peak Gastroenterology Associates
- Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
- Gastroenterology Associates of Fairfield County, P.C.
- TrialSpark, Inc.
- Innovative Research of West FL, Inc.
- West Central Gastroenterology
- Clinical Research of West Florida
- ALL Medical Research LLC
- Top Medical Research
- Palmetto Research, LLC
- Vida Clinical Trials
- Nature Coast Clinical Research
- Panax Clinical Research, LLC.
- Savin Medical Group LLC
- APF Research LLC
- AMPM Research Clinic
- Advanced Medical Research Institute
- Florida Research Center, Inc.
- American Research Institute, Inc
- Synexus
- Atlanta Diabetes Associates
- Emory University
- River Birch Research Alliance, LLC
- Gwinnett Research Institute, LLC
- Summit Clinical Research, LLC.
- iResearch Atlanta LLC
- Infinite Clinical Trials
- Clinical Research Consultants of Atlanta
- Rocky Mountain Diabetes and Osteoporosis Center, PA
- Southwest Gastroenterology
- MediSphere Medical Research Center, LLC
- American Research, LLC
- University of Iowa Hospitals and Clinics
- University of Kansas Medical Center
- Health Science Research Center
- WestGlen Gastrointestinal Consultants
- Cotton-O'Neil Clinical Research Center - Digestive Health
- Kansas Medical Clinic
- Professional Research Network of Kansas, LLC
- Via Christi Clinic, PA
- Tri-State Gastroenterology
- University of Louisville
- Delta Research Partners
- WK Physicians Network
- Avant Research Associates LLC
- Cronola LLC
- Clinical Trials of SWLA, LLC
- Tandem Clinical Research
- New Orleans Research Institute - Metropolitan Gastroenterology Associates
- Clinical Trials of America, Inc.
- Trialspark - Silverman
- Gastro Center of Maryland
- Frederick Gastroenterology Associates, PA an Elligo Health Research Site
- Woodholme Gastroenterology Associates, P.A.
- Meridian Clinical Research, LLC
- Commonwealth Clinical Studies, PLLC.
- Clinical Research Institute of Michigan
- Vida Clinical Studies
- Aa Mrc Llc
- National Clinical, LLC
- Gastroenterology Associates of Western Michigan
- Minnesota Gastroenterology, P.A.
- Montana Medical Research
- Methodist Physicians Clinic Diabetes and Endocrine Specialists
- Heartland Clinical Research, Inc
- Excel Clinical Research
- Clinical Research of South Nevada
- Advanced Biomedical Research of America
- Digestive Disease Specialists
- Palm Research Center
- Garden State Endocrinology
- AGA Clinical Research Associates LLC
- Lovelace Scientific Resources, Inc.
- Long Island Gastrointestinal Research Group LLP
- Synexus Clinical Research US, Inc.
- United Health Services Hospitals, Inc.
- Asheville Gastroenterology Associates
- University of North Carolina at Chapel Hill
- Carolina Digestive Health Associates, PA
- Cumberland Research Associates, LLC
- Triad Clinical Trials
- Vidant Multispeciality Clinic - Kinston
- Diabetes and Endocrinology Consultants, PC
- PMG Research Salisbury
- PMG Research of Wilmington, LLC
- Trial Management Associates, LLC
- PMG Research of Winston-Salem, LLC
- The Center for Clinical Research
- Dayton Gastroenterology, Inc.
- Diabetes & Endocrinology Associates of Stark County, Inc.
- Synexus Clinical Research US - Cincinnati
- Endocrinology Research Associates, Inc.
- The Ohio State University, Wexner Medical Center
- Aventiv Research, Inc.
- Hometown Urgent Care and Research
- CIC America Clinical Inquest Center Ltd.
- Hometown Urgent Care and Research
- Premier Clinical Research d.b.a. STAT Research
- Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research
- Digestive Disease Specialists Inc
- Memorial Clinical Research
- Options Health Research, LLC
- Northwest Gastroenterology Clinic, LLC
- Family Medical Associates, Research Department
- Allegheny Endocrinology Associates
- Preferred Primary Care Physicians, Inc.
- Frontier Clinical Research, LLC
- Montgomery Medical, Inc.
- Preferred Primary Care Physicians
- Synexus Clinical Research US, Inc.
- Synexus Clinical Research US, Inc
- Clinical Trials of South Carolina
- Gastroenterology Associates, PA
- Health Concepts
- Clinsearch
- Gastro One
- Quality Medical Research
- Texas Clinical Research Institute, LLC
- Avant Research Associates,LLC
- ClinRx Research, LLC
- Synexus Clinical Research US, Inc.
- Biopharma Informatic Inc., Research Center
- Rodriguez Clinical Trials
- Amir Ali Hassan, MD, PA
- Sante Clinical Research
- Pinnacle Clinical Research
- Clinical Trials of Texas, Inc.
- Southern Star Research Institute, LLC
- Synexus Clinical Research US, Inc.
- Advanced Research Institute, Inc.
- Advanced Clinical Research
- Verity Research Inc.
- Manassas Clinical Research Centre
- Cardinal Internal Medicine Associates, PC
- Washington Gastroenterology PLLC
- West Virginia University
- Maffei Centro Medico-Investigacion Clinica Aplicada
- Hospital Sirio Libanes
- Centro de Investigaciones Medicas Mar del Plata
- Instituto Privado de Investigaciones Clínicas de Córdoba
- Instituto de Investigaciones Clinicas de Rosario
- Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli
- Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
- CIPREC
- Centro Universitario de Investigacion en Farmacologia Clinic
- Nepean Hospital
- Royal Adelaide Hospital
- Royal Melbourne Hospital
- Ordination
- VIVIT Institute, am LKH Feldkirch
- Privatklinik Wehrle-Diakonissen
- Landeskrankenhaus Steyr
- Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
- UZ Brussel
- AZ Sint Lucas Brugge
- Hospital Universitário Walter Cantídio
- Instituto de Estudos e Pesquisas Clinicas do Ceará IEP/CE - Oncology
- Centro de Pesquisa Clinica do Brasil
- Núcleo de Pesquisa Clínica do Rio Grande do Sul
- Instituto Catarinense de Endocrinologia e Diabetes (ICED)
- Scentryphar Pesquisa Clinica Ltda
- Instituto de Pesquisa Clinica de Campinas
- CPQuali Pesquisa Clinica Ltda
- Hospital Universitário João de Barros Barreto
- IPEC-Instituto de Pesquisa Clinica
- MHAT Yuliya Vrevska Byala
- UMHAT - Kaspela- EOOD
- University of Calgary
- Alberta Diabetes Institute
- Central Alberta Research Centre
- Vancouver General Hospital
- South Shore Medical Arts
- The Ottawa Hospital
- Toronto Digestive Disease Associates
- Recherche GCP Research
- Centro Cardiovascular Colombiano Clínica Santa María
- Rodrigo Botero S.A.S.
- Centro Cardiovascular y de Diabetes
- Fundacion BIOS
- Endocare Ltda.
- Healthy Medical Center
- Medplus Medicina Prepagada
- Asociación Colombiana de Diabetes
- Fundacion Centro de Investigaciones Clinicas CARDIOMET
- Centro Medico Imbanaco de Cali S.A.
- IPS Centro Medico Julian Coronel S.A
- Gentofte Hospital
- Gastroenheden, Hvidovre hospital
- Klinische Forschung Karlsruhe GmbH
- Studienzentrum Schwittay
- Klinische Forschung Dresden GmbH
- Clinical Research Hamburg
- Israelitisches Krankenhaus
- KRH Klinikum Siloah
- First Department of Medicine, University of Szeged
- Markhot Ferenc Oktatokorhaz es Rendelointezet
- Hetenyi Geza Hospital
- Zala Megyei Szent Rafael Korhaz
- Synexus Budapest DRS
- Strázsahegy Gyógyszertár Medicina
- Kumudini Devi Diabetes Research Center; Ramdevrao Hospital
- King George Hospital
- Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre
- Victoria Hospital
- Life Care Hospital & Research Centre
- Diacon Hospital and research Center - Diabetology
- Rajalakshmi Hospital
- Vinaya Hospital & Research Centre
- Bhatia Hospital
- B. J. Government Medical College and Sassoon General Hospitals
- Universal Hospital
- Noble Hospital
- S.R. Kalla (SRK) Memorial Gastro & General Hospital
- Diabetic Thyroid and Endocrine Centre
- Marudhar Hospital
- Eternal Hospital - Diabetology
- SMS Hospital
- Kovai Diabetes Speciality Centre
- Arthur Asirvatham Hospital
- M. V Hospital & Research Centre
- Sir Ganga Ram Hospital
- Bnai Zion Medical Center
- Endocrinology & Diabetes Center
- Chonbuk National University Hospital
- Diabetes Center
- Asan Medical Center
- Kraslava Hospital
- Polana-D
- Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
- Digestive Diseases Centre GASTRO
- Hospital Sultanah Bahiyah
- Universiti Sains Malaysia
- Hospital Taiping
- Mentrials SA DE CV
- Clinicos Asociados BOCM SC
- Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology
- Centro de Investigación y Atención de Diabetes - Endocrinología y Nutrición
- Unidad de Investigacion Clinica Cardiometabolica de Occidente, S.C.
- Consultorio Medico
- Unidad de Investigación Clínica en Medicina S.C.
- Centro de Atención e Investigación en Factores de Riesgo Car
- Centro de Desarrollo Biomédico S.C.P
- Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
- Hospital Cardiologica Aguascalientes
- Dioderm Instituto de Investigacion
- Sociedad de Metabolismo y Corazon, S.C.
- West Visayas State University Medical Center
- St. Luke's Medical Center
- Cardinal Santos Medical Center
- Manila Doctors Hospital, Ermita
- San Juan De Dios Educational Foundation, Inc.
- Ospital ng Makati
- Perpetual Succor Hospital
- NZOZ Vita Diabetica - Malgorzata Buraczyk
- Endoskopia Sp. Z O.O.
- Centrum Medyczne Lukamed
- Specjalistyczny Gabinet Neurologiczny Marta Banach
- Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
- Saint-Petersburg City Pokrovskaya Hospital
- Scientific Institute of Clinical and Experimental Lymphology
- North-Western State Medical University named after I. I. Mechnikov
- Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko
- Kazan State Medical University
- FSBI National medical endocrinology research centre
- Moscow Regional Research Clinical Institute named by MF Vladimirski
- Rostov on Don
- Rostov State Medical University
- GUZ Saratov City Clinical Hospital 9
- Saratov City Clinical Hospital 12
- National University Hospital
- Singapore General Hospital
- Changi General Hospital
- FARMOVS
- Wits Clinical Research
- Synexus Stanza Clincal Reaserch Centre
- Watermeyer Clinical Research Site
- Synexus Helderberg Clinical Research Centre
- Phramongkutklao Hospital
- Faculty of Medicine, Siriraj Hospital, Mahidol University
- Maharaj Nakorn Chiang Mai Hospital
- Ivano-Frankivsk National Medical University
- Ivano-Frankivsk Central City Clinical Hospital
- 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
- Regional Public Organization "Chernivtsi Regional Endocrinology Center"
- State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
- Municipal nonprofit entity of Kharkiv municipal council
- L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine
- Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"
- Communal Institution Kherson City Clinical Hospital
- Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv
- Kyiv clinical hospital on railway transport #2 of the "Healthcare Centre" branch of JSC "Ukrainian Railway"
- Medical Center Universal Clinic Oberig
- Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit
- Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University
- Communal Institution "Odesa Regional Clinical Hospital", Out-patient department
- Poltava Regional Clinical Hospital
- Ternopil University Hospital
- Private Small-Scale Enterprise Medical Centre Pulse
- Vinnytsia Regional Clinical highly specialized Endocrinology Centre
- Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia
- 6th City Clinical Hospital, c. Zaporizhzhia
- Municipal Institution, City Hospital #7
- Biomedical Research Centre
- MAC Clinical Research Manchester
- Royal Oldham Hospital
- MAC Research, Exchange House
- MAC Clinical Research, Monarch House
- MAC Research
- MAC Clinical Research, Kaman Court
- Mid Essex Hospital Services NHS Trust Broomfield Hospital
- MAC Clinical Research
- MAC Clinical Research, GAC House
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Treatment Period: Placebo
Treatment Period: Relamorelin 10 μg
Randomized Withdrawal Period: Placebo then Relamorelin 10 μg
Randomized Withdrawal Period: Relamorelin 10 μg then Relamorelin 10 μg
Randomized Withdrawal Period: Relamorelin 10 μg then Placebo
Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.
Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.
Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.
Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.