A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

July 8, 2021 updated by: Allergan

A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
336

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Nepean Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • UMHAT - Kaspela- EOOD
      • Sofia, Bulgaria, 1303
        • Medical Center Asklepion - Humane Medicine Research EOOD
      • Sofia, Bulgaria, 1431
        • Alexandrovska University Hospital
    • Ruse
      • Byala, Ruse, Bulgaria, 7100
        • MHAT Yuliya Vrevska Byala
  • France
      • Nantes Cedex 1, France, 44093
        • CHU Nantes
      • Rouen Cedex, France, 76031
        • Hopital Charles Nicolle
  • India
      • Madurai, India, 625020
        • Arthur Asirvatham Hospital
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500072
        • Kumudini Devi Diabetes Research Center; Ramdevrao Hospital
      • Visakhapatnam, Andhra Pradesh, India, 530002
        • King George Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India, 380007
        • Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Victoria Hospital
      • Bangalore, Karnataka, India, 560092
        • Life Care Hospital & Research Centre
      • Bengaluru, Karnataka, India, 359-360
        • Diacon Hospital and research Center - Diabetology
      • Bengaluru, Karnataka, India, 560097
        • Rajalakshmi Hospital
      • Mangalore, Karnataka, India, 575003
        • Vinaya Hospital & research Centre
    • Maharashtra
      • Mumbai, Maharashtra, India, 400007
        • Bhatia Hospital
      • Pune, Maharashtra, India, 411001
        • B. J. Government Medical College and Sassoon General Hospitals
      • Pune, Maharashtra, India, 411011
        • Universal Hospital
      • Pune, Maharashtra, India, 411013
        • Noble Hospital Pvt. Ltd
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • S R Kalla (SRK) Memorial Gastro & General Hospital
      • Jaipur, Rajasthan, India, 302004
        • SMS Hospital
      • Jaipur, Rajasthan, India, 302006
        • Diabetic Thyroid and Endocrine Centre
      • Jaipur, Rajasthan, India, 302012
        • Marudhar Hospital
      • Jaipur, Rajasthan, India, 302017
        • Eternal Hospital - Diabetology
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600013
        • M.V. Hospital for Diabetes & Diabetes Research Centre
      • Coimbatore, Tamil Nadu, India, 641009
        • Kovai Diabetes Speciality Centre
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • M V Hospital & Research Centre
  • Israel
      • Beer Sheba, Israel, 85025
        • Soroka University Medical Center
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Holon, Israel, 58100
        • E. Wolfson Medical Center
      • Jerusalem, Israel, 9103102
        • Digestive Diseases Institute
      • Petach Tikva, Israel, 49100
        • Gastroenterology Institute
      • Safed, Israel, 13100
        • Endocrinology & Diabetes Center
      • Tel Aviv, Israel, 64239
        • Gastroenterology Institute
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
    • Jeollabuk-Do
      • Jeonju, Jeollabuk-Do, Korea, Republic of, 561-712
        • Chonbuk National University Hospital
    • Nowon-gu
      • Seoul, Nowon-gu, Korea, Republic of, 01757
        • Sanggye Paik Hospital, Inje University College of Medicine
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
      • Kubang Kerian, Malaysia, 16150
        • Universiti Sains Malaysia
      • Taiping, Malaysia, 34000
        • Hospital Taiping
    • Kedah
      • Alor Setar, Kedah, Malaysia, 5460
        • Hospital Sultanah Bahiyah
  • Philippines
      • Cebu City, Philippines, 6000
        • Perpetual Succor Hospital
      • IloIlo City, Philippines, 5000
        • West Visayas State University Medical Center
      • Quezon City, Philippines, 1100
        • St. Luke's Medical Center
    • Manila
      • Ermita, Manila, Philippines, 1000
        • Manila Doctors Hospital
    • Metro Manila
      • Pasay, Metro Manila, Philippines, 1300
        • San Juan De Dios Educational Foundation, Inc.
      • San Juan City, Metro Manila, Philippines, 1502
        • Cardinal Santos Medical Center
    • NCR
      • Makati City, NCR, Philippines, 1218
        • Ospital ng Makati
  • Poland
      • Bialystok, Poland, 15-798
        • NZOZ Vita Diabetica - Malgorzata Buraczyk
      • Chojnice, Poland, 89-600
        • Centrum Medyczne Lukamed
      • Czestochowa, Poland, 42-202
        • Synexus Polska sp.z.o.o oddzial Czestochowa
      • Kraków, Poland, 30-539
        • Specjalistyczny Gabinet Neurologiczny Marta Banach
      • Lodz, Poland, 90-127
        • Synexus Polska Sp. z o.o. Oddzial w Lodzi
      • Lublin, Poland, 20-090
        • Sanitas Centrum Medyczne
      • Warszawa, Poland
        • Synexus Polska Sp. z o.o. Oddzial w Warszawie
      • Wroclaw, Poland, 50-381
        • DRS Wroclaw
      • Wroclaw, Poland, 51-162
        • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
    • Gdansk
      • Pomorskie, Gdansk, Poland, 80-382
        • Synexus Polska Sp.z o.o.
    • Malopolska
      • Krakow, Malopolska, Poland, 31-530
        • CenterMed Krakow Ltd
    • Mazowian
      • Warsaw, Mazowian, Poland, 01-868
        • Centrum Medyczne Pratia S.A. Warsaw, Poland
    • Pomorskie
      • Sopot, Pomorskie, Poland, 81-756
        • Endoskopia Sp. z o.o.
    • Poznañ
      • Poznan, Poznañ, Poland, 60-702
        • Synexus Polska Sp. z o.o.Oddzial w Poznaniu
    • Warmia-Mazury
      • Olsztyn, Warmia-Mazury, Poland, 10-561
        • Wojewodzki Szpital Specjalistyczny w Olsztynie
  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital
      • Singapore, Singapore, 119228
        • National University Hospital
      • Singapore, Singapore, S169856
        • Singapore General Hospital
  • Spain
      • Madrid, Spain, 28850
        • Hospital Universitario Príncipe de Asturias
      • Salamanca, Spain, 37007
        • Hospital Universitario De Salamanca
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen del Rocio
  • Thailand
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
      • Bangkok, Thailand, 10700
        • Faculty of Medicine, Siriraj Hospital, Mahidol University
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
  • Ukraine
      • Chernivtsi, Ukraine, 58001
        • 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
      • Chernivtsi, Ukraine, 58022
        • Regional Public Organization Chernivtsi Regional Endocrinology Center
      • Dnipro, Ukraine, 49027
        • State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
      • Ivano-Frankivsk, Ukraine, 76008
        • Ivano-Frankivsk National Medical University
      • Ivano-Frankivsk, Ukraine, 76018
        • Ivano-Frankivsk Central City Clinical Hospital
      • Kharkiv, Ukraine, 61037
        • Municipal nonprofit entity of Kharkiv municipal council
      • Kharkiv, Ukraine, 61039
        • L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine
      • Kharkiv, Ukraine, 61070
        • Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"
      • Kherson, Ukraine, 73000
        • Communal Institution Kherson City Clinical Hospital
      • Kyiv, Ukraine, 01034
        • Kyiv municipal clinical endocrinological center
      • Kyiv, Ukraine, 03037
        • AS Medbud Clinic
      • Kyiv, Ukraine, 2002
        • AS PVNZ
      • Kyiv, Ukraine, 2002
        • Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv
      • Kyiv, Ukraine, 3049
        • Kyiv Railway hospital on the railway transport #2 of the branch "health
      • Kyiv, Ukraine, 3680
        • Medical Center Universal Clinic Oberig
      • Kyiv, Ukraine, 4050
        • Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit
      • Odesa, Ukraine, 65010
        • Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University
      • Poltava, Ukraine, 36011
        • Poltava Regional Clinical Hospital
      • Ternopil, Ukraine, 46002
        • Ternopil University Hospital
      • Vinnytsia, Ukraine, 21001
        • Private Small-Scale Enterprise Medical Centre Pulse
      • Vinnytsia, Ukraine, 21010
        • Vinnytsia Regional Clinical highly specialized Endocrinology Centre
      • Vinnytsia, Ukraine, 21029
        • Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia
      • Zaporizhzhia, Ukraine, 69035
        • 6th City Clinical Hospital, c. Zaporizhzhia
    • Odesa Region
      • Odesa, Odesa Region, Ukraine, 65025
        • Communal Institution "Odesa Regional Clinical Hospital", Out-patient department
    • Vinnyts'ka Oblast'
      • Vinnitsa, Vinnyts'ka Oblast', Ukraine, 21050
        • Limited Liability Company "Medical Center "Salutem"
    • Zaporizhzhia Region
      • Zaporizhzhia, Zaporizhzhia Region, Ukraine, 69600
        • Municipal Institution City Hospital No. 7
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35295
        • University of Alabama at Birmingham
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialist of the South East
      • Huntsville, Alabama, United States, 35801
        • Avant Research Associates
    • Arizona
      • Fountain Hills, Arizona, United States, 85268
        • Synexus Clinical Research US, Inc.
      • Mesa, Arizona, United States, 85206
        • Central Arizona Medical Associates
      • Phoenix, Arizona, United States, 85014
        • Phoenix Clinical LLC
      • Tucson, Arizona, United States, 85712
        • Del Sol Research Management, LLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners, Inc.
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Gastorenterology
    • California
      • Canoga Park, California, United States, 91303
        • HOPE Clinical Research
      • Corona, California, United States, 92879
        • Kindred Medical Institute for Clinical Trials, LLC
      • Costa Mesa, California, United States, 92627
        • Aurora Care Clinic, LLC
      • Covina, California, United States, 91722
        • Citrus Valley Gastroenterology Clinic
      • Garden Grove, California, United States, 92845
        • VVCRD Research
      • La Jolla, California, United States, 92037
        • University of California San Diego
      • Lancaster, California, United States, 93534
        • Om Research LLC
      • San Diego, California, United States, 92103
        • Clinical Applications Laboratories, Inc.
      • San Diego, California, United States, 92123
        • Medical Associates Research Group, Inc
      • Santa Rosa, California, United States, 95405
        • Synexus Clinical Research, US, Santa Rosa
      • Upland, California, United States, 91786
        • Upland Clinical Research
      • Vista, California, United States, 92083
        • Synexus Clinical Research US, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Denver
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
      • Englewood, Colorado, United States, 80110
        • Denver Esophageal and Stomach Center
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Connecticut Clinical Research Foundation
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 20017
        • TrialSpark, Inc.
    • Florida
      • Clearwater, Florida, United States, 33756
        • Innovative Research of West FL, Inc.
      • Clearwater, Florida, United States, 33756
        • West Central Gastroenterology
      • Cutler Bay, Florida, United States, 33157
        • American Research Institute, INC
      • Cutler Bay, Florida, United States, 33189
        • Top Medical Research
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Maitland, Florida, United States, 32751
        • Cfagi Llc
      • Miami, Florida, United States, 33134
        • APF Research LLC
      • Miami, Florida, United States, 33169
        • AMPM Research Clinic
      • Miami, Florida, United States, 33174
        • Advanced Medical Research Institute
      • Miami, Florida, United States, 33174
        • Florida Research Center, Inc.
      • Miami Lakes, Florida, United States, 33014
        • Savin Medical Group LLC
      • Ocoee, Florida, United States, 34761
        • Sensible Healthcare
      • Pensacola, Florida, United States, 32514
        • Gulf Region Clinical Research Institute
      • Tampa, Florida, United States, 33606
        • University of South Florida
      • Tampa, Florida, United States, 33626
        • West Central Gastroenterology
    • Georgia
      • Carnesville, Georgia, United States, 30521
        • Summit Clinical Research, LLC
      • Riverdale, Georgia, United States, 30274
        • Infinite Clinical Trials
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Southwest Gastroenterology
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
      • Evansville, Indiana, United States, 47714
        • Synexus Clinical Research US, Inc.
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health University Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center - Digestive Health
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • Delta Research Partners
      • Houma, Louisiana, United States, 70360
        • CroNola LLC
      • Metairie, Louisiana, United States, 70006
        • New Orleans Research Institute - Metropolitan Gastroenterology Associates
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland
      • Frederick, Maryland, United States, 21701
        • Frederick Gastroenterology Associates, PA an Elligo Health Research Site
    • Massachusetts
      • West Roxbury, Massachusetts, United States, 02132
        • Boston VA Healthcare System
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Vida Clinical Studies
      • Hamtramck, Michigan, United States, 48212
        • National Clinical, LLC
      • Novi, Michigan, United States, 48377
        • Henry Ford Health System
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55446
        • MNGI Digestive Health
      • Richfield, Minnesota, United States, 55423
        • Synexus Clinical Research US, Inc.
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Synexus Clinical Research
      • Las Vegas, Nevada, United States, 89121
        • Clinical Research of South Nevada
      • Las Vegas, Nevada, United States, 89123
        • Advanced Biomedical Research of America
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research
      • Las Vegas, Nevada, United States, 89128
        • Digestive Disease Specialists
      • Las Vegas, Nevada, United States, 89135
        • Palm Research Center
    • New Jersey
      • Brick, New Jersey, United States, 08723
        • Garden State Endocrinology
      • Bridgeton, New Jersey, United States, 08302
        • Synexus Clinical Research US, Inc.
      • Egg Harbor Township, New Jersey, United States, 08234
        • Aga Clinical Research Associates LLC
    • New York
      • Bronx, New York, United States, 10455
        • CHEAR Center, LLC
      • Great Neck, New York, United States, 11023
        • Long Island Gastrointestinal Research Group LLP
      • Johnson City, New York, United States, 13790
        • United Health Services Hospitals, Inc.
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates
      • Chapel Hill, North Carolina, United States, 27599-7080
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Healthcare-Charlotte
      • Concord, North Carolina, United States, 28025
        • Carolina Digestive Health Associates
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates, LLC
      • Greensboro, North Carolina, United States, 27410
        • Triad Clinical Trials
      • Salisbury, North Carolina, United States, 28144
        • PMG Research Salisbury
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research
    • Ohio
      • Beavercreek, Ohio, United States, 45440
        • Dayton Gastroenterology,Inc.
      • Columbus, Ohio, United States, 43201
        • Endocrinology Research Associates, Inc.
      • Columbus, Ohio, United States, 43214
        • Hometown Urgent Care and Research
      • Franklin, Ohio, United States, 45005
        • Premier Clinical Research d.b.a. STAT Research
      • Wadsworth, Ohio, United States, 44281
        • Family Practice Center of Wadsworth, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Digestive Disease Specialists Inc
      • Oklahoma City, Oklahoma, United States, 73120
        • Memorial Clinical Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Gastroenterology Clinic, LLC
    • Pennsylvania
      • Levittown, Pennsylvania, United States, 19056
        • Family Medical Associates, Research Department
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians, Inc.
      • Smithfield, Pennsylvania, United States, 15478
        • Montgomery Medical, Inc.
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Synexus Clinical Research US, Inc.
      • Clinton, South Carolina, United States, 29325
        • Carolina Medical Research
      • Greenville, South Carolina, United States, 29615
        • Gastroenterology Associates, PA
      • Greer, South Carolina, United States, 29650
        • Synexus Clinical Research
    • Tennessee
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research
    • Texas
      • Austin, Texas, United States, 78704
        • Avant Research Associates,LLC
      • Dallas, Texas, United States, 75234
        • Synexus Clinical Research US, Inc.
      • Houston, Texas, United States, 77089
        • Amir Ali Hassan, MD, PA
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, United States, 78229
        • Sagact Pllc
    • Utah
      • Layton, Utah, United States, 84041
        • Synexus Clinical Research US, Inc.
      • Murray, Utah, United States, 84123
        • Synexus Clinical Research US, Inc.
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute, Inc.
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Verity Research Inc.
      • Woodbridge, Virginia, United States, 22192
        • Cardinal Internal Medicine
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
Drug: Placebo
Placebo injected subcutaneously twice daily.
Experimental: Relamorelin 10 μg
Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Drug: Relamorelin
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
Time Frame: Baseline (Day-14 to Day-1) to Week 12
Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the Run-in Period.
Baseline (Day-14 to Day-1) to Week 12
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Time Frame: Week 6 to Week 12
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.
Week 6 to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea.
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no abdominal pain to 10=the worst possible abdominal pain and was recorded in an e-diary.
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no bloating and 10=the worst possible bloating and was recorded in the e-diary.
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no feeling of fullness until finishing a meal (best) to 10=feeling full after only a few bites (worst).
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
Time Frame: Up to approximately 16 weeks
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Up to approximately 16 weeks
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Time Frame: Up to 12 weeks
Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Up to 12 weeks
Number of Participants With Clinically Meaningful Trends for Vital Signs
Time Frame: Up to 12 weeks
Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the results were clinically significant.
Up to 12 weeks
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Time Frame: Up to 12 weeks
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Up to 12 weeks
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Time Frame: Baseline (Day 1) up to 12 weeks
HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percentage of the absolute maximum that can be bound.
Baseline (Day 1) up to 12 weeks
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
Time Frame: Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)
A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.
Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Wieslaw (Wes) Bochenek, MD, PhD, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RLM-MD-01
  • 2017-002136-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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