Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
NCT ID: NCT02357420
Last Updated: 2019-07-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
393 participants
INTERVENTIONAL
2015-01-29
2016-06-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
NCT02025751
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
NCT02025725
Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis
NCT00845858
A Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) for TAK-906 in Participants With Diabetes Mellitus and Gastroparesis (DG) or With Idiopathic Gastroparesis (IG)
NCT03268941
Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis
NCT01262898
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Relamorelin 10 μg
Relamorelin 10 microgram (μg) was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.
Relamorelin
Double blind relamorelin was given subcutaneously BID for 12 weeks.
Relamorelin 30 μg
Relamorelin 30 μg was administered SC by injection BID for 12 weeks.
Relamorelin
Double blind relamorelin was given subcutaneously BID for 12 weeks.
Relamorelin 100 μg
Relamorelin 100 μg was administered SC by injection BID for 12 weeks.
Relamorelin
Double blind relamorelin was given subcutaneously BID for 12 weeks.
Placebo
Placebo-matching relamorelin was administered SC by injection BID for 12 weeks.
Placebo
Placebo given subcutaneously for 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Relamorelin
Double blind relamorelin was given subcutaneously BID for 12 weeks.
Placebo
Placebo given subcutaneously for 12 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diabetic gastroparesis (DG), defined as at least a 3-month history of symptoms suggestive of gastroparesis on an ongoing basis (e.g., vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain).
* Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) score ≥2.6 at least once during the Screening Period (Visits 1-2).
* At least 2 vomiting episodes during the \~2 weeks prior to the first screening visit (Visit 1), as ascertained by patient history.
* Delayed Gastric Emptying (GE) confirmed at screening by abnormal Gastric Emptying Breath Test (GEBT), defined as GE half-time (t1/2) ≥79 minutes (the 80th percentile of normative data). At least 50% of patients enrolled will have a t1/2 ≥97 minutes (i.e., the 95th percentile).
* Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to Visit 2 (daily adjustments of insulin doses are permitted).
* No use of metoclopramide, erythromycin, domperidone, or other gastrointestinal (GI) motility agents, or anti-emetics for at least 2 weeks prior to Visit 2, and willingness to remain off these medications (except as used as part of protocol-specific rescue medication) during the course of the clinical trial.
* Body mass index \>18 kg/m2.
* If female, has a negative serum or urine pregnancy test and is not lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female patients unable to bear children must have this documented in the electronic case report form (eCRF) (i.e., tubal ligation, hysterectomy, or post-menopausal \[defined as a minimum of 1 year since the last menstrual period\]). Post-menopausal status will be confirmed by measurement of follicle stimulating hormone (FSH).
* Able to provide written informed consent prior to any study procedures and willing and able to comply with study procedures.
* Compliance with the completion of the Diabetic Gastroparesis Symptom Severity Diary (DGSSD) and study drug injections, defined as approximately 80% diary completions and approximately 80% administration of injections, during the 2-week single-blind placebo run-in period. For those patients whose compliance is measured to be \<80%, the final decision to randomize a patient will be made by the Investigator and the Sponsor (or designee).
* At least one vomiting episode at any time during the 2-week single-blind placebo run-in period, as recorded in the DGSSD.
Exclusion Criteria
* History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure. (A history of diagnostic endoscopy is not exclusionary.)
* History of pyloric injection of botulinum toxin within 6 months of screening.
* Patients with clinical suspicion of upper GI obstruction (e.g., peptic stricture) must have been evaluated per standard of care and obstruction ruled out before screening.
* Currently taking opiates, or expecting to use opiates during the course of the clinical trial.
* Currently taking Glucagon-like peptide-1 (GLP-1) agonists, Sodium-glucose co-transporter 2 (SGLT2) inhibitors or pramlintide.
* Allergic or intolerant of egg, wheat, milk, or algae, as these are components of the Gastric emptying breath test (GEBT) study meal. (Gluten-free crackers can be provided.)
* History of anorexia nervosa, binge-eating, or bulimia within 5 years of screening.
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 × upper limit of normal (ULN) at Visit 1.
* History of intestinal malabsorption or pancreatic exocrine disease.
* Requires hemodialysis or has end-stage renal disease.
* History of human immunodeficiency virus (HIV) infection.
* Clinically significant neurologic or psychiatric disorders that are likely to impact compliance with protocol requirements.
* Poor venous access or inability to tolerate venipuncture.
* Participation in a clinical study within the 30 days prior to dosing in the present study.
* Any other reason that, in the Investigator's opinion, would confound proper interpretation of the study or expose a patient to unacceptable risk, including renal, hepatic or cardiopulmonary disease, or significant acute electrocardiogram (ECG) abnormalities.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wieslaw Bochenek, MD
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Digestive Health Specialist of the Southeast
Dothan, Alabama, United States
Huntsville, Alabama, United States
Desert Sun Clinical Research
Tucson, Arizona, United States
Adobe Clinical Research
Tucson, Arizona, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States
Arkansas Primary Care Clinic
Little Rock, Arkansas, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
TriWest Research Associates
El Cajon, California, United States
Torrance Clinical Research Institute Inc.
Lomita, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Ventura Clinical Trials
Ventura, California, United States
Danbury Hospital- Office of Clinical trials
Danbury, Connecticut, United States
Avail Clinical Research
DeLand, Florida, United States
International Research Associates LLC
Hialeah, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
APF Research, LLC
Miami, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Baptist Diabetes Associates, P.A.
Miami, Florida, United States
Miami, Florida, United States
International Research Associates LLC
Miami, Florida, United States
Advanced Research Institute Inc
New Port Richey, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
River Birch Research Alliance LLC
Blue Ridge, Georgia, United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States
Medisphere Medical Research Center
Evansville, Indiana, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Delta Research Partners
Monroe, Louisiana, United States
Clinical Trials of America LA, LLC
West Monroe, Louisiana, United States
Metropolitan Gastroenterology Group, P.C. (Chevy Chase Clinical Research) Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Detroit Clinical Research Center, PC-Farmington Hills
Farmington Hills, Michigan, United States
Center For Digestive Health
Troy, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Planters Clinic
Port Gibson, Mississippi, United States
Impact Clinical Trials
Las Vegas, Nevada, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Great Neck, New York, United States
New York Clinical Trials, Inc
New York, New York, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States
OnSite Clinical Solutions- Lexington OnSite Clinical Solutions, LLC
Lexington, North Carolina, United States
Diabetes and Endocrinology Consultants, P.C.
Morehead City, North Carolina, United States
OnSite Clinical Solutions, LLC
Statesville, North Carolina, United States
Trial Management Associates, LLC
Wilmington, North Carolina, United States
Wake Forest University Baptist Health - Dept of Gastroenterology Medical Center Blvd
Winston-Salem, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
MetroHealth Medical Center
Leveland, Ohio, United States
Great Lakes Gastroenterology Research
Mentor, Ohio, United States
Northwest Gastroenterology Clinic
Portland, Oregon, United States
Family Medicine of SayeBrook
Myrtle Beach, South Carolina, United States
ClinSearch LLC
Chattanooga, Tennessee, United States
El Paso, Texas, United States
GI Specialists of Houston
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
The University of Texas Health Science Center & Medical School at Houston
Houston, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Gulf Coast Medical Research, LLC
Sugar Land, Texas, United States
Aspen Clinical Research
Orem, Utah, United States
Highland Clinical Research
Salt Lake City, Utah, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Khan and Abbasi Research
Chester, Virginia, United States
Healing Hands of Virginia LLC
Richmond, Virginia, United States
Gastroenterology Consultants
Virginia Beach, Virginia, United States
ZainResearch, LLC
Richland, Washington, United States
Hopital Erasme - Universite Libre de Bruxelles
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Herz und Diabeteszentrum Nordrhein Westfalen, Universitätsklinikum der Ruhr-Universiät Bochum
Bad Oeynhausen, , Germany
Praxis Dr. Ott Rabenauer Str.
Dippoldiswalde, , Germany
GWT-TUD GmbH
Dresden, , Germany
Israelitisches Krankenhaus Orchideenstig
Hamburg, , Germany
Diabetes Zentrum und Praxis Prof. Pfützner Parcusstr.
Mainz, , Germany
Rambam Health Care Campus - Inst. of Endocrinology, Diabetes, and Metabolism
Haifa, , Israel
Wolfson Medical Center
Holon, , Israel
Rabin Medical Center, Beilinson Hospital Gastroenterology Dept
Petah Tikva, , Israel
ZIV Medical Center
Safed, , Israel
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J. ul.
Bialystok, , Poland
NZOZ Witamed al.
Kielce, , Poland
CenterMed Krakow
Krakow, , Poland
Gabinet Lekarski dr n.med. Malgorzata Saryusz-Wolska ul.
Lodz, , Poland
NZOZ Pulsmedica ul.
Lodz, , Poland
KO-MED Centra Kliniczne
Staszów, , Poland
Centrum Badawcze Wspólczesnej Terapii ul.
Warsaw, , Poland
Warsaw, , Poland
Gastroenterology Karolinska University Hospital Karolinska Universitetssjukhuset Gastro Centrum Medicine
Stockholm, , Sweden
Uppsala University Hospital Gastroenterology / Mag-Tarmmottagningen ingang
Uppsala, , Sweden
NHS Tayside
Dundee, Scotland, United Kingdom
Wansbeck General Hospital (Northumbria NHS Trust)
Ashington, , United Kingdom
University Hospital of North Durham University Hospital of North Durham Research and Development Directorate
Durham, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
King's College Hospital
London, , United Kingdom
The James Cook University Hospital
Middlesbrough, , United Kingdom
Tyne and Wear, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Camilleri M, Lembo A, McCallum R, Tourkodimitris S, Kemps L, Miller MB, Bertelsen K, Iacob A. Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data. Aliment Pharmacol Ther. 2020 Jun;51(11):1139-1148. doi: 10.1111/apt.15711. Epub 2020 Apr 17.
Camilleri M, McCallum RW, Tack J, Spence SC, Gottesdiener K, Fiedorek FT. Efficacy and Safety of Relamorelin in Diabetics With Symptoms of Gastroparesis: A Randomized, Placebo-Controlled Study. Gastroenterology. 2017 Nov;153(5):1240-1250.e2. doi: 10.1053/j.gastro.2017.07.035. Epub 2017 Jul 29.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-005623-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RM-131-009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.