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

Overview

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.

Full Title of Study: “Phase 3 Companion Study of Intranasal Metoclopramide in Men With Symptomatic Diabetic Gastroparesis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2016

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.

Interventions

  • Drug: Metoclopramide Nasal Spray
    • One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
  • Drug: Placebo Nasal Spray
    • One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)

Arms, Groups and Cohorts

  • Experimental: Metoclopramide Nasal Spray
    • Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
  • Placebo Comparator: Placebo Nasal Spray
    • Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • 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 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 – 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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Evoke Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marilyn R Carlson, DMD, MD, Study Director, Evoke Pharma, Inc.

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