Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
- Conditions
- Diabetic Gastroparesis
- Interventions
- Drug: Placebo Nasal Spray
- Registration Number
- NCT02025725
- Lead Sponsor
- Evoke Pharma
- Brief Summary
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.
- Detailed Description
Diabetic women with clinical symptoms attributed to diabetic gastroparesis and documentation of delayed gastric emptying who meet the protocol-specified entry criteria will be randomized to Metoclopramide Nasal Spray 10 mg or placebo administered as a single intranasal spray four (4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 205
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Nasal Spray Placebo Nasal Spray Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks 10 mg Metoclopramide Nasal Spray Metoclopramide Nasal Spray Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
- Primary Outcome Measures
Name Time Method Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure Baseline Period to Week 4 of the Treatment Period Change from the Baseline Period to Week 4 of the Treatment Period in the mean daily Gastroparesis Symptom Assessment (GSA) total score for subjects receiving Metoclopramide Nasal Spray 10 mg versus subjects receiving placebo. The GSA minimum value is 0 (no symptoms) and the maximum value is 4 (very severe symptoms). A higher score is a worse outcome.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (49)
Atlanta Gastroenterology Associates
🇺🇸Marietta, Georgia, United States
Kinston Medical Specialist Clinical Research Office
🇺🇸Kinston, North Carolina, United States
Southwest Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
HCCA Clinical Research Solutions
🇺🇸Jackson, Tennessee, United States
Lovelace Scientific Resources
🇺🇸Austin, Texas, United States
Lovelace Scientific Resources, Inc.
🇺🇸Albuquerque, New Mexico, United States
LeBauer Research Associates
🇺🇸Greensboro, North Carolina, United States
Cumberland Research Associates
🇺🇸Fayetteville, North Carolina, United States
Gastroenterology Associates of Western Michigan
🇺🇸Wyoming, Michigan, United States
Premier Medical Group of the Hudson, PC
🇺🇸Poughkeepsie, New York, United States
Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
The Gastroenterology Group of South Jersey
🇺🇸Vineland, New Jersey, 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
John Muir Physician Network Clinical Research Center
🇺🇸Concord, California, United States
Arkansas Gastroenterology
🇺🇸Sherwood, Arkansas, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Advanced Medical Research
🇺🇸Port Orange, Florida, United States
Tri-County Research
🇺🇸Athens, Georgia, United States
Newton Medical Center
🇺🇸Conyers, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Delta Research Partners, LLC
🇺🇸Monroe, Louisiana, United States
Clinical Research Institute of Michigan
🇺🇸Chesterfield, Michigan, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Gastrointestional Associates
🇺🇸Jackson, Mississippi, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
Gastroenterology Associates, LLC
🇺🇸Baton Rouge, Louisiana, United States
PMG Research of Salisbury
🇺🇸Salisbury, North Carolina, United States
The Center for Gastrointestinal Disorders
🇺🇸Hollywood, Florida, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
Professional Research Network of Kansas
🇺🇸Wichita, Kansas, United States
National Clinical Research
🇺🇸Norfolk, Virginia, United States
Gastroenterology Associates
🇺🇸Kingsport, Tennessee, United States
Birmingham Gasteroenterology Associates, P.C.
🇺🇸Birmingham, Alabama, United States
Precision Research Institute, LLC
🇺🇸San Diego, California, United States
International Research Associates, LLC
🇺🇸Miami, Florida, United States
Quality Medical Research
🇺🇸Nashville, Tennessee, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Kansas City Gastroenterology & Hepatology
🇺🇸Kansas City, Missouri, United States
Piedmont Medical Research
🇺🇸Winston-Salem, North Carolina, United States
Indiana University Health UH 1634
🇺🇸Indianapolis, Indiana, United States
Manassas Clinical Research
🇺🇸Manassas, Virginia, United States
Dayton Gastroenterology
🇺🇸Beavercreek, Ohio, United States
Burke Internal Medicine
🇺🇸Burke, Virginia, United States