Clinical trial NCT03285308: A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
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: 2017-09-18
Enrollment: 336
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: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialist of the South East
state: Alabama
city: Huntsville
country: United States
facility: Avant Research Associates
state: Alabama
city: Fountain Hills
country: United States
facility: Synexus Clinical Research US, Inc.
state: Arizona
city: Mesa
country: United States
facility: Central Arizona Medical Associates
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Clinical LLC
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Gastorenterology
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Costa Mesa
country: United States
facility: Aurora Care Clinic, LLC
state: California
city: Covina
country: United States
facility: Citrus Valley Gastroenterology Clinic
state: California
city: Garden Grove
country: United States
facility: VVCRD Research
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: San Diego
country: United States
facility: Clinical Applications Laboratories, Inc.
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc
state: California
city: Santa Rosa
country: United States
facility: Synexus Clinical Research, US, Santa Rosa
state: California
city: Upland
country: United States
facility: Upland Clinical Research
state: California
city: Vista
country: United States
facility: Synexus Clinical Research US, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Englewood
country: United States
facility: Denver Esophageal and Stomach Center
state: Colorado
city: Bristol
country: United States
facility: Connecticut Clinical Research Foundation
state: Connecticut
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Washington
country: United States
facility: TrialSpark, Inc.
state: District of Columbia
city: Clearwater
country: United States
facility: Innovative Research of West FL, Inc.
state: Florida
city: Clearwater
country: United States
facility: West Central Gastroenterology
state: Florida
city: Cutler Bay
country: United States
facility: American Research Institute, Inc
state: Florida
city: Cutler Bay
country: United States
facility: Top Medical Research
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Maitland
country: United States
facility: Cfagi Llc
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group LLC
state: Florida
city: Miami
country: United States
facility: APF Research LLC
state: Florida
city: Miami
country: United States
facility: AMPM Research Clinic
state: Florida
city: Miami
country: United States
facility: Advanced Medical Research Institute
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc.
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare
state: Florida
city: Pensacola
country: United States
facility: Gulf Region Clinical Research Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: West Central Gastroenterology
state: Florida
city: Carnesville
country: United States
facility: Summit Clinical Research, LLC
state: Georgia
city: Riverdale
country: United States
facility: Infinite Clinical Trials
state: Georgia
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Evansville
country: United States
facility: Synexus Clinical Research US, Inc.
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center - Digestive Health
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Bastrop
country: United States
facility: Delta Research Partners
state: Louisiana
city: Houma
country: United States
facility: Cronola LLC
state: Louisiana
city: Metairie
country: United States
facility: New Orleans Research Institute - Metropolitan Gastroenterology Associates
state: Louisiana
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Frederick
country: United States
facility: Frederick Gastroenterology Associates, PA an Elligo Health Research Site
state: Maryland
city: West Roxbury
country: United States
facility: Boston VA Healthcare System
state: Massachusetts
city: Dearborn
country: United States
facility: Vida Clinical Studies
state: Michigan
city: Hamtramck
country: United States
facility: National Clinical, LLC
state: Michigan
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan
state: Michigan
city: Coon Rapids
country: United States
facility: MNGI Digestive Health
state: Minnesota
city: Richfield
country: United States
facility: Synexus Clinical Research US, Inc.
state: Minnesota
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Henderson
country: United States
facility: Synexus Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Las Vegas
country: United States
facility: Digestive Disease Specialists
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Brick
country: United States
facility: Garden State Endocrinology
state: New Jersey
city: Bridgeton
country: United States
facility: Synexus Clinical Research US, Inc.
state: New Jersey
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates LLC
state: New Jersey
city: Bronx
country: United States
facility: CHEAR Center, LLC
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group LLP
state: New York
city: Johnson City
country: United States
facility: United Health Services Hospitals, Inc.
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Healthcare-Charlotte
state: North Carolina
city: Concord
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Greensboro
country: United States
facility: Triad Clinical Trials
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research Salisbury
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Beavercreek
country: United States
facility: Dayton Gastroenterology,Inc.
state: Ohio
city: Columbus
country: United States
facility: Endocrinology Research Associates, Inc.
state: Ohio
city: Columbus
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Franklin
country: United States
facility: Premier Clinical Research d.b.a. STAT Research
state: Ohio
city: Wadsworth
country: United States
facility: Family Practice Center of Wadsworth, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists Inc
state: Oklahoma
city: Oklahoma City
country: United States
facility: Memorial Clinical Research
state: Oklahoma
city: Portland
country: United States
facility: Northwest Gastroenterology Clinic, LLC
state: Oregon
city: Levittown
country: United States
facility: Family Medical Associates, Research Department
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: Smithfield
country: United States
facility: Montgomery Medical, Inc.
state: Pennsylvania
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc.
state: South Carolina
city: Clinton
country: United States
facility: Carolina Medical Research
state: South Carolina
city: Greenville
country: United States
facility: Gastroenterology Associates, PA
state: South Carolina
city: Greer
country: United States
facility: Synexus Clinical Research
state: South Carolina
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Austin
country: United States
facility: Avant Research Associates,LLC
state: Texas
city: Dallas
country: United States
facility: Synexus Clinical Research US, Inc.
state: Texas
city: Houston
country: United States
facility: Amir Ali Hassan, MD, PA
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Sagact Pllc
state: Texas
city: Layton
country: United States
facility: Synexus Clinical Research US, Inc.
state: Utah
city: Murray
country: United States
facility: Synexus Clinical Research US, Inc.
state: Utah
city: Ogden
country: United States
facility: Advanced Research Institute, Inc.
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Fairfax
country: United States
facility: Verity Research Inc.
state: Virginia
city: Woodbridge
country: United States
facility: Cardinal Internal Medicine
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Byala
country: Bulgaria
facility: MHAT Yuliya Vrevska Byala
state: Ruse
city: Plovdiv
country: Bulgaria
facility: UMHAT - Kaspela- EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Asklepion - Humane Medicine Research EOOD
city: Sofia
country: Bulgaria
facility: Alexandrovska University Hospital
city: Nantes Cedex 1
country: France
facility: CHU Nantes
city: Rouen Cedex
country: France
facility: Hopital Charles Nicolle
city: Hyderabad
country: India
facility: Kumudini Devi Diabetes Research Center; Ramdevrao Hospital
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology
state: Gujarat
city: Bangalore
country: India
facility: Victoria Hospital
state: Karnataka
city: Bangalore
country: India
facility: Life Care Hospital & Research Centre
state: Karnataka
city: Bengaluru
country: India
facility: Diacon Hospital and research Center - Diabetology
state: Karnataka
city: Bengaluru
country: India
facility: Rajalakshmi Hospital
state: Karnataka
city: Mangalore
country: India
facility: Vinaya Hospital & Research Centre
state: Karnataka
city: Mumbai
country: India
facility: Bhatia Hospital
state: Maharashtra
city: Pune
country: India
facility: B. J. Government Medical College and Sassoon General Hospitals
state: Maharashtra
city: Pune
country: India
facility: Universal Hospital
state: Maharashtra
city: Pune
country: India
facility: Noble Hospital Pvt. Ltd
state: Maharashtra
city: Jaipur
country: India
facility: S R Kalla (SRK) Memorial Gastro & General Hospital
state: Rajasthan
city: Jaipur
country: India
facility: SMS Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Diabetic Thyroid and Endocrine Centre
state: Rajasthan
city: Jaipur
country: India
facility: Marudhar Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Eternal Hospital - Diabetology
state: Rajasthan
city: Chennai
country: India
facility: M.V. Hospital for Diabetes & Diabetes Research Centre
state: Tamil Nadu
city: Coimbatore
country: India
facility: Kovai Diabetes Speciality Centre
state: Tamil Nadu
city: Lucknow
country: India
facility: M V Hospital & Research Centre
state: Uttar Pradesh
city: Madurai
country: India
facility: Arthur Asirvatham Hospital
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Beer Sheba
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Holon
country: Israel
facility: E. Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Digestive Diseases Institute
city: Petach Tikva
country: Israel
facility: Gastroenterology Institute
city: Safed
country: Israel
facility: Endocrinology & Diabetes Center
city: Tel Aviv
country: Israel
facility: Gastroenterology Institute
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-Do
city: Seoul
country: Korea, Republic of
facility: Sanggye Paik Hospital, Inje University College of Medicine
state: Nowon-gu
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
state: Kedah
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kubang Kerian
country: Malaysia
facility: Universiti Sains Malaysia
city: Taiping
country: Malaysia
facility: Hospital Taiping
city: Ermita
country: Philippines
facility: Manila Doctors Hospital
state: Manila
city: Pasay
country: Philippines
facility: San Juan De Dios Educational Foundation, Inc.
state: Metro Manila
city: San Juan City
country: Philippines
facility: Cardinal Santos Medical Center
state: Metro Manila
city: Makati City
country: Philippines
facility: Ospital ng Makati
state: NCR
city: Cebu City
country: Philippines
facility: Perpetual Succor Hospital
city: IloIlo City
country: Philippines
facility: West Visayas State University Medical Center
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: Pomorskie
country: Poland
facility: Synexus Polska Sp.z o.o.
state: Gdansk
city: Krakow
country: Poland
facility: CenterMed Krakow Ltd
state: Malopolska
city: Warsaw
country: Poland
facility: Centrum Medyczne Pratia S.A. Warsaw, Poland
state: Mazowian
city: Sopot
country: Poland
facility: Endoskopia Sp. Z O.O.
state: Pomorskie
city: Poznan
country: Poland
facility: Synexus Polska Sp. z o.o.Oddzial w Poznaniu
state: Poznañ
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Olsztynie
state: Warmia-Mazury
city: Bialystok
country: Poland
facility: NZOZ Vita Diabetica - Malgorzata Buraczyk
city: Chojnice
country: Poland
facility: Centrum Medyczne Lukamed
city: Czestochowa
country: Poland
facility: Synexus Polska sp.z.o.o oddzial Czestochowa
city: Kraków
country: Poland
facility: Specjalistyczny Gabinet Neurologiczny Marta Banach
city: Lodz
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Lodzi
city: Lublin
country: Poland
facility: Sanitas Centrum Medyczne
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Wroclaw
country: Poland
facility: DRS Wroclaw
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Madrid
country: Spain
facility: Hospital Universitario Principe de Asturias
city: Salamanca
country: Spain
facility: Hospital Universitario De Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital, Mahidol University
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Odesa
country: Ukraine
facility: Communal Institution "Odesa Regional Clinical Hospital", Out-patient department
state: Odesa Region
city: Vinnitsa
country: Ukraine
facility: Limited Liability Company "Medical Center "Salutem"
state: Vinnyts'ka Oblast'
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution City Hospital No. 7
state: Zaporizhzhia Region
city: Chernivtsi
country: Ukraine
facility: Regional 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 diseases, c.C
city: Chernivtsi
country: Ukraine
facility: Regional Public Organization Chernivtsi Regional Endocrinology Center
city: Dnipro
country: Ukraine
facility: State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk National Medical University
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Central City Clinical Hospital
city: Kharkiv
country: Ukraine
facility: Municipal nonprofit entity of Kharkiv municipal council
city: Kharkiv
country: Ukraine
facility: L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine
city: Kharkiv
country: Ukraine
facility: Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"
city: Kherson
country: Ukraine
facility: Communal Institution Kherson City Clinical Hospital
city: Kyiv
country: Ukraine
facility: Kyiv municipal clinical endocrinological center
city: Kyiv
country: Ukraine
facility: AS Medbud Clinic
city: Kyiv
country: Ukraine
facility: AS PVNZ
city: Kyiv
country: Ukraine
facility: Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv
city: Kyiv
country: Ukraine
facility: Kyiv Railway hospital on the railway transport #2 of the branch "health
city: Kyiv
country: Ukraine
facility: Medical Center Universal Clinic Oberig
city: Kyiv
country: Ukraine
facility: Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit
city: Odesa
country: Ukraine
facility: Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Hospital
city: Ternopil
country: Ukraine
facility: Ternopil University Hospital
city: Vinnytsia
country: Ukraine
facility: Private Small-Scale Enterprise Medical Centre Pulse
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical highly specialized Endocrinology Centre
city: Vinnytsia
country: Ukraine
facility: Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia
city: Zaporizhzhia
country: Ukraine
facility: 6th City Clinical Hospital, c. Zaporizhzhia
Study officials:
affiliation: Allergan
name: Wieslaw (Wes) Bochenek, MD, PhD
role: STUDY_DIRECTOR
References: