Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis

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) 11.5% at screening
• Subjects who are trying to conceive, are pregnant, or are lactating