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Prokinetic Agent
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
Phase 3
Waitlist Available
Research Sponsored by Evoke Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline period to week 4 of the treatment period
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions
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.
Eligible Conditions
- Gastroparesis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline period to week 4 of the treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline period to week 4 of the treatment period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure
Side effects data
From 2016 Phase 3 trial • 205 Patients • NCT020257255%
Headache
3%
Diarrhoea
2%
Muscle twitching
2%
Ear pain
2%
Oropharyngeal pain
2%
Fatigue
1%
orthostatic hypotension
1%
cellulitis
1%
chalazion
1%
Abdominal pain
1%
Constipation
1%
Cough
1%
Nasal discomfort
1%
Abdominal tenderness
1%
Epistaxis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Metoclopramide Nasal Spray
Placebo Nasal Spray
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 10 mg Metoclopramide Nasal SprayExperimental Treatment1 Intervention
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Group II: Placebo Nasal SprayPlacebo Group1 Intervention
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metoclopramide
FDA approved
Find a Location
Who is running the clinical trial?
Evoke PharmaLead Sponsor
2 Previous Clinical Trials
340 Total Patients Enrolled
2 Trials studying Gastroparesis
340 Patients Enrolled for Gastroparesis
Marilyn R. Carlson, DMD, MDStudy DirectorEvoke Pharma, Inc.