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

June 16, 2020 updated by: Evoke Pharma

Phase 3 Companion Study of Intranasal Metoclopramide in Men With Symptomatic Diabetic Gastroparesis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Birmingham Gasteroenterology Associates, P.C.
      • Dothan, Alabama, United States, 36305
        • Digestive Specialists of the Southeast
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Central Arizone Medical Associates/Clinical Research Advantage
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners
      • Sherwood, Arkansas, United States, 72120
        • Arkansas Gastroenterology
    • California
      • Chula Vista, California, United States, 91910
        • Precision Research Institute, LLC
      • Concord, California, United States, 94520
        • John Muir Physician Network Clinical Research Center
      • San Diego, California, United States, 92114
        • Precision Research Institute, LLC
    • Florida
      • Hollywood, Florida, United States, 33021
        • The Center for Gastrointestinal Disorders
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Miami, Florida, United States, 33183
        • International Research Associates, LLC
      • Port Orange, Florida, United States, 32127
        • Advanced Medical Research
    • Georgia
      • Athens, Georgia, United States, 30606
        • Tri-County Research
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia
      • Conyers, Georgia, United States, 30013
        • Newton Medical Center
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia, PC
      • Marietta, Georgia, United States, 30067
        • Atlanta Gastroenterology Associates
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Southwest Gastroenterology
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health UH 1634
    • Kansas
      • Wichita, Kansas, United States, 67203
        • Professional Research Network of Kansas
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates, LLC
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners, LLC
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan
      • Troy, Michigan, United States, 48098
        • Center for Digestive Health
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Gastroenterology & Hepatology
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Vineland, New Jersey, United States, 08360
        • The Gastroenterology Group of South Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Lovelace Scientific Resources, Inc.
    • New York
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson, PC
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates
      • Greensboro, North Carolina, United States, 27406
        • LeBauer Research Associates
      • Kinston, North Carolina, United States, 28501
        • Kinston Medical Specialist Clinical Research Office
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
      • Salisbury, North Carolina, United States, 28144
        • PMG Research of Salisbury
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research
    • Ohio
      • Beavercreek, Ohio, United States, 45440
        • Dayton Gastroenterology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
    • Tennessee
      • Jackson, Tennessee, United States, 37805
        • HCCA Clinical Research Solutions
      • Kingsport, Tennessee, United States, 37660
        • Gastroenterology Associates
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute
      • Austin, Texas, United States, 78758
        • Lovelace Scientific Resources
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center
    • Virginia
      • Burke, Virginia, United States, 22015
        • Burke Internal Medicine
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research
      • Norfolk, Virginia, United States, 23502
        • National Clinical Research
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Center for Advanced Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metoclopramide Nasal Spray
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Drug: Metoclopramide Nasal Spray
One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
Placebo Comparator: Placebo Nasal Spray
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Drug: Placebo Nasal Spray
One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
Other Names:
  • Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evoke Pharma

Investigators

  • Study Director: Marilyn R Carlson, DMD, MD, Evoke Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 29, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (Estimate)

January 1, 2014

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METO-IN-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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