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GastroparesisPhase 3NCT03285308

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

A Phase 3 study testing Relamorelin in people with Gastroparesis and Diabetes Mellitus, run by Allergan at 216 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastroparesis, Diabetes Mellitus
What is being tested?
Relamorelin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
336 participants
Where
216 sitesin 14 countries
Study dates
29 Sep 2017to 8 Jul 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

216 sites in 14 countries.

216 sites in 14 countries

United States113 sites

  • Synexus Clinical Research US, Inc.

    Anderson, South Carolina, 29621

  • Asheville Gastroenterology Associates

    Asheville, North Carolina, 28801

  • University of Colorado, Denver

    Aurora, Colorado, 80045

  • Avant Research Associates,LLC

    Austin, Texas, 78704

  • Delta Research Partners

    Bastrop, Louisiana, 71220

  • Dayton Gastroenterology,Inc.

    Beavercreek, Ohio, 45440

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35295

  • Garden State Endocrinology

    Brick, New Jersey, 08723

  • Synexus Clinical Research US, Inc.

    Bridgeton, New Jersey, 08302

  • Connecticut Clinical Research Foundation

    Bristol, Connecticut, 06010

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Summit Clinical Research, LLC

    Carnesville, Georgia, 30521

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7080

  • Carolinas Healthcare-Charlotte

    Charlotte, North Carolina, 28204

  • Innovative Research of West FL, Inc.

    Clearwater, Florida, 33756

  • West Central Gastroenterology

    Clearwater, Florida, 33756

  • Carolina Medical Research

    Clinton, South Carolina, 29325

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • Endocrinology Research Associates, Inc.

    Columbus, Ohio, 43201

  • Hometown Urgent Care and Research

    Columbus, Ohio, 43214

  • Carolina Digestive Health Associates

    Concord, North Carolina, 28025

  • MNGI Digestive Health

    Coon Rapids, Minnesota, 55446

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Aurora Care Clinic, LLC

    Costa Mesa, California, 92627

  • Citrus Valley Gastroenterology Clinic

    Covina, California, 91722

  • American Research Institute, Inc

    Cutler Bay, Florida, 33157

  • Top Medical Research

    Cutler Bay, Florida, 33189

  • Synexus Clinical Research US, Inc.

    Dallas, Texas, 75234

  • Vida Clinical Studies

    Dearborn, Michigan, 48124

  • Digestive Health Specialist of the South East

    Dothan, Alabama, 36305

  • AGA Clinical Research Associates LLC

    Egg Harbor, New Jersey, 08234

  • Denver Esophageal and Stomach Center

    Englewood, Colorado, 80110

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Synexus Clinical Research US, Inc.

    Evansville, Indiana, 47714

  • Verity Research Inc.

    Fairfax, Virginia, 22031

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304

  • Synexus Clinical Research US, Inc.

    Fountain Hills, Arizona, 85268

  • Premier Clinical Research d.b.a. STAT Research

    Franklin, Ohio, 45005

  • Frederick Gastroenterology Associates, PA an Elligo Health Research Site

    Frederick, Maryland, 21701

  • VVCRD Research

    Garden Grove, California, 92845

  • Long Island Gastrointestinal Research Group LLP

    Great Neck, New York, 11023

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410

  • Gastroenterology Associates, PA

    Greenville, South Carolina, 29615

  • Synexus Clinical Research

    Greer, South Carolina, 29650

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • National Clinical, LLC

    Hamtramck, Michigan, 48212

  • Synexus Clinical Research

    Henderson, Nevada, 89052

  • Cronola LLC

    Houma, Louisiana, 70360

  • Amir Ali Hassan, MD, PA

    Houston, Texas, 77089

  • Avant Research Associates

    Huntsville, Alabama, 35801

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • United Health Services Hospitals, Inc.

    Johnson City, New York, 13790

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of California San Diego

    La Jolla, California, 92037

  • Om Research LLC

    Lancaster, California, 93534

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89121

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Digestive Disease Specialists

    Las Vegas, Nevada, 89128

  • Palm Research Center

    Las Vegas, Nevada, 89135

  • Synexus Clinical Research US, Inc.

    Layton, Utah, 84041

  • Family Medical Associates, Research Department

    Levittown, Pennsylvania, 19056

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211

  • University of Louisville

    Louisville, Kentucky, 40202

  • Cfagi Llc

    Maitland, Florida, 32751

  • Central Arizona Medical Associates

    Mesa, Arizona, 85206

  • New Orleans Research Institute - Metropolitan Gastroenterology Associates

    Metairie, Louisiana, 70006

  • APF Research LLC

    Miami, Florida, 33134

  • AMPM Research Clinic

    Miami, Florida, 33169

  • Advanced Medical Research Institute

    Miami, Florida, 33174

  • Florida Research Center, Inc.

    Miami, Florida, 33174

  • Savin Medical Group LLC

    Miami Lakes, Florida, 33014

  • Montana Medical Research

    Missoula, Montana, 59808

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Synexus Clinical Research US, Inc.

    Murray, Utah, 84123

  • Quality Medical Research

    Nashville, Tennessee, 37211

  • Arkansas Gastorenterology

    North Little Rock, Arkansas, 72117

  • Henry Ford Health System

    Novi, Michigan, 48377

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453

  • Sensible Healthcare

    Ocoee, Florida, 34761

  • Advanced Research Institute, Inc.

    Ogden, Utah, 84405

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma, 73112

  • Memorial Clinical Research

    Oklahoma City, Oklahoma, 73120

  • Gulf Region Clinical Research Institute

    Pensacola, Florida, 32514

  • Phoenix Clinical LLC

    Phoenix, Arizona, 85014

  • Preferred Primary Care Physicians, Inc.

    Pittsburgh, Pennsylvania, 15236

  • Northwest Gastroenterology Clinic, LLC

    Portland, Oregon, 97210

  • Synexus Clinical Research US, Inc.

    Richfield, Minnesota, 55423

  • Infinite Clinical Trials

    Riverdale, Georgia, 30274

  • PMG Research Salisbury

    Salisbury, North Carolina, 28144

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Sagact Pllc

    San Antonio, Texas, 78229

  • Clinical Applications Laboratories, Inc.

    San Diego, California, 92103

  • Medical Associates Research Group, Inc

    San Diego, California, 92123

  • Synexus Clinical Research, US, Santa Rosa

    Santa Rosa, California, 95405

  • Montgomery Medical, Inc.

    Smithfield, Pennsylvania, 15478

  • University of South Florida

    Tampa, Florida, 33606

  • West Central Gastroenterology

    Tampa, Florida, 33626

  • CHEAR Center, LLC

    The Bronx, New York, 10455

  • Cotton-O'Neil Clinical Research Center - Digestive Health

    Topeka, Kansas, 66606

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85712

  • Upland Clinical Research

    Upland, California, 91786

  • Synexus Clinical Research US, Inc.

    Vista, California, 92083

  • Family Practice Center of Wadsworth, Inc.

    Wadsworth, Ohio, 44281

  • TrialSpark, Inc.

    Washington D.C., District of Columbia, 20017

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Boston VA Healthcare System

    West Roxbury, Massachusetts, 02132

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

  • Cardinal Internal Medicine

    Woodbridge, Virginia, 22192

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan, 49519

Other trials in United States

Ukraine26 sites

  • 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, 58001

  • Regional Public Organization Chernivtsi Regional Endocrinology Center

    Chernivtsi, 58022

  • State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine

    Dnipro, 49027

  • Ivano-Frankivsk National Medical University

    Ivano-Frankivsk, 76008

  • Ivano-Frankivsk Central City Clinical Hospital

    Ivano-Frankivsk, 76018

  • Municipal nonprofit entity of Kharkiv municipal council

    Kharkiv, 61037

  • L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine

    Kharkiv, 61039

  • Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"

    Kharkiv, 61070

  • Communal Institution Kherson City Clinical Hospital

    Kherson, 73000

  • Kyiv municipal clinical endocrinological center

    Kyiv, 01034

  • AS Medbud Clinic

    Kyiv, 03037

  • AS PVNZ

    Kyiv, 2002

  • Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv

    Kyiv, 2002

  • Kyiv Railway hospital on the railway transport #2 of the branch "health

    Kyiv, 3049

  • Medical Center Universal Clinic Oberig

    Kyiv, 3680

  • Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit

    Kyiv, 4050

  • Communal Institution "Odesa Regional Clinical Hospital", Out-patient department

    Odesa, Odesa Oblast, 65025

  • Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University

    Odesa, 65010

  • Poltava Regional Clinical Hospital

    Poltava, 36011

  • Ternopil University Hospital

    Ternopil, 46002

  • Limited Liability Company "Medical Center "Salutem"

    Vinnitsa, Vinnytsia Oblast, 21050

  • Private Small-Scale Enterprise Medical Centre Pulse

    Vinnytsia, 21001

  • Vinnytsia Regional Clinical highly specialized Endocrinology Centre

    Vinnytsia, 21010

  • Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia

    Vinnytsia, 21029

  • Municipal Institution City Hospital No. 7

    Zaporizhzhya, Zaporizhzhia Oblast, 69600

  • 6th City Clinical Hospital, c. Zaporizhzhia

    Zaporizhzhya, 69035

Other trials in Ukraine

India22 sites

  • Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology

    Ahmedabad, Gujarat, 380007

  • Victoria Hospital

    Bangalore, Karnataka, 560002

  • Life Care Hospital & Research Centre

    Bangalore, Karnataka, 560092

  • Diacon Hospital and research Center - Diabetology

    Bengaluru, Karnataka, 359-360

  • Rajalakshmi Hospital

    Bengaluru, Karnataka, 560097

  • M.V. Hospital for Diabetes & Diabetes Research Centre

    Chennai, Tamil Nadu, 600013

  • Kovai Diabetes Speciality Centre

    Coimbatore, Tamil Nadu, 641009

  • Kumudini Devi Diabetes Research Center; Ramdevrao Hospital

    Hyderabad, Andhra Pradesh, 500072

  • S R Kalla (SRK) Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302001

  • SMS Hospital

    Jaipur, Rajasthan, 302004

  • Diabetic Thyroid and Endocrine Centre

    Jaipur, Rajasthan, 302006

  • Marudhar Hospital

    Jaipur, Rajasthan, 302012

  • Eternal Hospital - Diabetology

    Jaipur, Rajasthan, 302017

  • M V Hospital & Research Centre

    Lucknow, Uttar Pradesh, 226003

  • Arthur Asirvatham Hospital

    Madurai, 625020

  • Vinaya Hospital & Research Centre

    Mangalore, Karnataka, 575003

  • Bhatia Hospital

    Mumbai, Maharashtra, 400007

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • B. J. Government Medical College and Sassoon General Hospitals

    Pune, Maharashtra, 411001

  • Universal Hospital

    Pune, Maharashtra, 411011

  • Noble Hospital Pvt. Ltd

    Pune, Maharashtra, 411013

  • King George Hospital

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Poland15 sites

  • NZOZ Vita Diabetica - Malgorzata Buraczyk

    Bialystok, 15-798

  • Centrum Medyczne Lukamed

    Chojnice, 89-600

  • Synexus Polska sp.z.o.o oddzial Czestochowa

    Częstochowa, 42-202

  • CenterMed Krakow Ltd

    Krakow, Malopolska, 31-530

  • Specjalistyczny Gabinet Neurologiczny Marta Banach

    Krakow, 30-539

  • Synexus Polska Sp. z o.o. Oddzial w Lodzi

    Lodz, 90-127

  • Sanitas Centrum Medyczne

    Lublin, 20-090

  • Wojewodzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, Warmian-Masurian Voivodeship, 10-561

  • Synexus Polska Sp.z o.o.

    Pomorskie, Gdansk, 80-382

  • Synexus Polska Sp. z o.o.Oddzial w Poznaniu

    Poznan, Poznañ, 60-702

  • Endoskopia Sp. Z O.O.

    Sopot, Pomeranian Voivodeship, 81-756

  • Centrum Medyczne Pratia S.A. Warsaw, Poland

    Warsaw, Mazowian, 01-868

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw

  • DRS Wroclaw

    Wroclaw, 50-381

  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

    Wroclaw, 51-162

Other trials in Poland

Israel7 sites

  • Soroka University Medical Center

    Beersheba, 85025

  • Bnai Zion Medical Center

    Haifa, 31048

  • E. Wolfson Medical Center

    Holon, 58100

  • Digestive Diseases Institute

    Jerusalem, 9103102

  • Gastroenterology Institute

    Petah Tikva, 49100

  • Endocrinology & Diabetes Center

    Safed, 13100

  • Gastroenterology Institute

    Tel Aviv, 64239

Other trials in Israel

Philippines7 sites

  • Perpetual Succor Hospital

    Cebu City, 6000

  • Manila Doctors Hospital

    Ermita, Manila, 1000

  • West Visayas State University Medical Center

    Iloilo City, 5000

  • Ospital ng Makati

    Makati City, NCR, 1218

  • San Juan De Dios Educational Foundation, Inc.

    Pasay, National Capital Region, 1300

  • St. Luke's Medical Center

    Quezon City, 1100

  • Cardinal Santos Medical Center

    San Juan City, National Capital Region, 1502

Other trials in Philippines

Australia4 sites

  • Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated

    Adelaide, South Australia, 5000

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Bulgaria4 sites

  • MHAT Yuliya Vrevska Byala

    Byala, Ruse, 7100

  • UMHAT - Kaspela- EOOD

    Plovdiv, 4001

  • Medical Center Asklepion - Humane Medicine Research EOOD

    Sofia, 1303

  • Alexandrovska University Hospital

    Sofia, 1431

Other trials in Bulgaria

Malaysia4 sites

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah, 5460

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Universiti Sains Malaysia

    Kubang Kerian, 16150

  • Hospital Taiping

    Taiping, 34000

Other trials in Malaysia

Singapore3 sites

  • National University Hospital

    Singapore, 119228

  • Changi General Hospital

    Singapore, 529889

  • Singapore General Hospital

    Singapore, S169856

Other trials in Singapore

South Korea3 sites

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do, 561-712

  • Sanggye Paik Hospital, Inje University College of Medicine

    Seoul, Nowon-gu, 01757

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Spain3 sites

  • Hospital Universitario Principe de Asturias

    Madrid, 28850

  • Hospital Universitario De Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocío

    Seville, 41009

Other trials in Spain

Thailand3 sites

  • Phramongkutklao Hospital

    Bangkok, 10400

  • Faculty of Medicine, Siriraj Hospital, Mahidol University

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

Other trials in Thailand

France2 sites

  • CHU Nantes

    Nantes, 44093

  • Hopital Charles Nicolle

    Rouen, 76031

Other trials in France

About this study

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

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.

Being tested
Placebo, Relamorelin
Medical subject headings
Gastroparesis, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo injected subcutaneously twice daily.

  • RelamorelinDrug

    Relamorelin 10 micrograms (μg) injected subcutaneously twice daily.

Study groups in NCT03285308
Study groupRoleWhat they receive
PlaceboPlacebo comparatorFollowing a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
Receives: Drug: Placebo
Relamorelin 10 μgExperimentalFollowing a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Receives: Drug: Relamorelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)

    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.

    Measured: Baseline (Day-14 to Day-1) to Week 12

  2. Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-week Treatment Period.

    Measured: Week 6 to Week 12

Secondary outcomes (10)

  1. Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 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.

    Measured: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

  2. Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 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.

    Measured: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

  3. Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 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.

    Measured: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

  4. Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 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).

    Measured: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

  5. 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.

    Measured: Up to approximately 16 weeks

  6. Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results

    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.

    Measured: Up to 12 weeks

  7. 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.

    Measured: Up to 12 weeks

  8. 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.

    Measured: Up to 12 weeks

  9. Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)

    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.

    Measured: Baseline (Day 1) up to 12 weeks

  10. Number of Participants With Anti-relamorelin Antibody Testing Results by Visit

    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.

    Measured: Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2017
  2. Study start29 Sep 2017
  3. Primary completion8 Jul 2020
  4. Study completion8 Jul 2020

Why it stopped: The Relamorelin program is being terminated solely based on a business decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03285308
Sponsor's protocol ID
RLM-MD-01
Other IDs
2017-002136-16, 2017
Status last verified
Jul 2021
First submitted
14 Sep 2017
Last updated
29 Jul 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Camilleri M, Jencks KJ. Pharmacologic treatments for gastroparesis. Pharmacol Rev. 2025 Mar;77(2):100019. doi: 10.1016/j.pharmr.2024.100019. Epub 2024 Nov 23.

    PubMed 40148033

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Relamorelin in people with Gastroparesis and Diabetes Mellitus, run by Allergan at 216 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 216 sites in United States, Ukraine, India, Poland, Israel and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03285308, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.

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