Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
NCT ID: NCT02025725
Last Updated: 2020-07-07
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
PHASE3
205 participants
INTERVENTIONAL
2014-03-27
2016-06-27
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
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
Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
NCT02357420
Study of Promethazine for Treatment of Diabetic Gastroparesis
NCT02130622
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
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
10 mg Metoclopramide Nasal Spray
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Metoclopramide Nasal Spray
nasal spray formulation of metoclopramide
Placebo Nasal Spray
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Placebo Nasal Spray
nasal spray formulation with vehicle only
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Metoclopramide Nasal Spray
nasal spray formulation of metoclopramide
Placebo Nasal Spray
nasal spray formulation with vehicle only
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
* Willingness and ability to give written informed consent
* The ability to read, understand and speak English
* Prior diagnosis of Type 1 or Type 2 diabetes
* Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying
* A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization
* Subjects of childbearing potential must agree to use contraception
* Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study
Exclusion Criteria
* A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product
* A history of, or physical findings suggestive of, tardive dyskinesia
* A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening
* A history of allergy to any of the ingredients in the study drug formulation
* A history of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, active inflammatory bowel disease (IBD), or symptomatic irritable bowel syndrome (IBS)
* Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening
* Renal dysfunction calculated as creatinine clearance (CrCl) \<40 mL/min at screening
* Hemoglobin A1c \>11.5% at screening
* Subjects who are trying to conceive, are pregnant, or are lactating
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Evoke Pharma
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.
Marilyn R. Carlson, DMD, MD
Role: STUDY_DIRECTOR
Evoke Pharma, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham Gasteroenterology Associates, P.C.
Birmingham, Alabama, United States
Digestive Specialists of the Southeast
Dothan, Alabama, United States
Clinical Research Associates
Huntsville, Alabama, United States
Central Arizone Medical Associates/Clinical Research Advantage
Mesa, Arizona, United States
Preferred Research Partners
Little Rock, Arkansas, United States
Arkansas Gastroenterology
Sherwood, Arkansas, United States
Precision Research Institute, LLC
Chula Vista, California, United States
John Muir Physician Network Clinical Research Center
Concord, California, United States
Precision Research Institute, LLC
San Diego, California, United States
The Center for Gastrointestinal Disorders
Hollywood, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
Advanced Medical Research
Port Orange, Florida, United States
Tri-County Research
Athens, Georgia, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, United States
Newton Medical Center
Conyers, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Atlanta Gastroenterology Associates
Marietta, Georgia, United States
Southwest Gastroenterology
Oak Lawn, Illinois, United States
Indiana University Health UH 1634
Indianapolis, Indiana, United States
Professional Research Network of Kansas
Wichita, Kansas, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States
Delta Research Partners, LLC
Monroe, Louisiana, United States
Clinical Research Institute of Michigan
Chesterfield, Michigan, United States
Center for Digestive Health
Troy, Michigan, United States
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, United States
Gastrointestional Associates
Jackson, Mississippi, United States
Kansas City Gastroenterology & Hepatology
Kansas City, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
The Gastroenterology Group of South Jersey
Vineland, New Jersey, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States
Premier Medical Group of the Hudson, PC
Poughkeepsie, New York, United States
Cumberland Research Associates
Fayetteville, North Carolina, United States
LeBauer Research Associates
Greensboro, North Carolina, United States
Kinston Medical Specialist Clinical Research Office
Kinston, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Piedmont Medical Research
Winston-Salem, North Carolina, United States
Dayton Gastroenterology
Beavercreek, Ohio, United States
Temple University
Philadelphia, Pennsylvania, United States
HCCA Clinical Research Solutions
Jackson, Tennessee, United States
Gastroenterology Associates
Kingsport, Tennessee, United States
Quality Medical Research
Nashville, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Lovelace Scientific Resources
Austin, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Burke Internal Medicine
Burke, Virginia, United States
Manassas Clinical Research
Manassas, Virginia, United States
National Clinical Research
Norfolk, Virginia, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
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.
McCallum RW, Parkman HP, Fass R, Bhandari BR, Carlson MR, Buck RD. Metoclopramide Nasal Spray in Women With Symptomatic Diabetic Gastroparesis: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2497-2505.e5. doi: 10.1016/j.cgh.2023.10.022. Epub 2023 Nov 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
METO-IN-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.