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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Gastroparesis

Intervention / Treatment
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* Drug: Metoclopramide Nasal Spray
* Drug: Placebo Nasal Spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 mg Metoclopramide Nasal Spray<br>Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks | Drug: Metoclopramide Nasal Spray<br>* nasal spray formulation of metoclopramide<br>* Other names: EVK-001;|
| Placebo Comparator: Placebo Nasal Spray<br>Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks | Drug: Placebo Nasal Spray<br>* nasal spray formulation with vehicle only<br>* Other names: EVK-001 Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure | 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. | Baseline Period to Week 4 of the Treatment Period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroparesis, Diabetic, Delayed gastric emptying, Gastric stasis, Nausea, Vomiting, Bloating, Abdominal pain, Early satiety, Gastropathy