At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 53 enrolled
Drug / intervention
Metoclopramide Nasal Spray +1 moredrug
Likely dose
Metoclopramide Nasal Spray 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3 Companion Study of Intranasal Metoclopramide in Men With Symptomatic Diabetic Gastroparesis
In Brief
A Phase 3 clinical trial evaluating Metoclopramide Nasal Spray and Placebo Nasal Spray for Diabetic Gastroparesis. Completed, enrolled 53 participants across 49 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Gastroparesis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartApr 2014
Primary CompletionAug 2016
Study CompletionOct 2016
TodayJul 2026
First PostedJan 1, 2014
Enrollment StartApr 1, 2014
Primary CompletionAug 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.5 years ago
Interventions
Metoclopramide Nasal Spraydrug
One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
Placebo Nasal Spraydrug
One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)