NCT02025725
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
Sponsored by Evoke Pharma
The purpose of this study is provide confirmation of the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult women.
Inclusion Criteria: * Non pregnant, non lactating female subjects between the ages of 18 and 75 years * 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: * Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility * 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
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
Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.
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