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

NCT02025725 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2020-07-07

Study results available
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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.

Conditions

  • Diabetic Gastroparesis

Interventions

DRUG

Metoclopramide Nasal Spray

nasal spray formulation of metoclopramide

DRUG

Placebo Nasal Spray

nasal spray formulation with vehicle only

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
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-27
Primary Completion
2016-05-27
Completion
2016-06-27

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 NCT02025725 on ClinicalTrials.gov