Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
- Conditions
- Diabetic Gastroparesis
- Interventions
- Drug: Placebo Nasal Spray
- Registration Number
- NCT02025751
- Lead Sponsor
- Evoke Pharma
- Brief Summary
The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.
- Detailed Description
Diabetic men 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
- Male
- Target Recruitment
- 53
- Male 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metoclopramide Nasal Spray Metoclopramide Nasal Spray Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks Placebo Nasal Spray Placebo Nasal Spray Placebo Nasal Spray 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 Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population) 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 (48)
The Center for Gastrointestinal Disorders
🇺🇸Hollywood, Florida, United States
Central Arizone Medical Associates/Clinical Research Advantage
🇺🇸Mesa, Arizona, United States
Advanced Medical Research
🇺🇸Port Orange, Florida, United States
John Muir Physician Network Clinical Research Center
🇺🇸Concord, California, United States
Atlanta Gastroenterology Associates
🇺🇸Marietta, Georgia, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
Lovelace Scientific Resources
🇺🇸Austin, Texas, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
National Clinical Research
🇺🇸Norfolk, Virginia, United States
Tri-County Research
🇺🇸Athens, Georgia, United States
Dayton Gastroenterology
🇺🇸Beavercreek, Ohio, United States
Southwest Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
Gastroenterology Associates of Western Michigan
🇺🇸Wyoming, Michigan, United States
Lovelace Scientific Resources, Inc.
🇺🇸Albuquerque, New Mexico, United States
Manassas Clinical Research
🇺🇸Manassas, Virginia, United States
Burke Internal Medicine
🇺🇸Burke, Virginia, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Premier Medical Group of the Hudson, PC
🇺🇸Poughkeepsie, New York, United States
Digestive Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
Newton Medical Center
🇺🇸Conyers, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Professional Research Network of Kansas
🇺🇸Wichita, Kansas, United States
Gastroenterology Associates, LLC
🇺🇸Baton Rouge, Louisiana, United States
Clinical Research Institute of Michigan
🇺🇸Chesterfield, Michigan, United States
Kinston Medical Specialist Clinical Research Office
🇺🇸Kinston, North Carolina, United States
LeBauer Research Associates
🇺🇸Greensboro, North Carolina, United States
Cumberland Research Associates
🇺🇸Fayetteville, North Carolina, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
PMG Research of Salisbury
🇺🇸Salisbury, North Carolina, United States
HCCA Clinical Research Solutions
🇺🇸Jackson, Tennessee, United States
Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Gastroenterology Associates
🇺🇸Kingsport, Tennessee, United States
Delta Research Partners, LLC
🇺🇸Monroe, Louisiana, United States
Arkansas Gastroenterology
🇺🇸Sherwood, Arkansas, United States
The Gastroenterology Group of South Jersey
🇺🇸Vineland, New Jersey, 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
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
Piedmont Medical Research
🇺🇸Winston-Salem, North Carolina, United States
Indiana University Health UH 1634
🇺🇸Indianapolis, Indiana, United States
Kansas City Gastroenterology & Hepatology
🇺🇸Kansas City, Missouri, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Quality Medical Research
🇺🇸Nashville, Tennessee, United States