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

Phase 3 Study of Intranasal Metoclopramide in Women With Symptomatic Diabetic Gastroparesis

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.

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.

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