Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Intervention: Metoclopramide Nasal Spray; Placebo Nasal Spray
Intervention description: nasal spray formulation of metoclopramide; nasal spray formulation with vehicle only
Intervention MeSH terms: Metoclopramide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 205.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Gastroparesis; Diabetic; Delayed gastric emptying; Gastric stasis; Nausea; Vomiting; Bloating; Abdominal pain; Early satiety; Gastropathy

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.
    

Eligibility criteria:

        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