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

NCT02025751 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2020-07-07

Study results available
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Summary

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.

Conditions

  • Diabetic Gastroparesis

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)

Sponsors & Collaborators

  • Evoke Pharma

    lead INDUSTRY

Principal Investigators

  • Marilyn R Carlson, DMD, MD · Evoke Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-08-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02025751 on ClinicalTrials.gov