At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 287 enrolled
Drug / intervention
metoclopramide +1 moredrug
Likely dose
Not stated in 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.
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Dose-Ranging Clinical Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Subjects With Gastroparesis
In Brief
A Phase 2 clinical trial evaluating metoclopramide and Placebo for Gastroparesis and 4 related conditions. Completed, enrolled 287 participants across 65 sites.
Detailed Summary
To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic gastroparesis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroparesis, Diabetic Gastroparesis, Diabetes, Diabetes Mellitus, Delayed Gastric Emptying
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartApr 2009
Primary CompletionDec 2011
TodayJul 2026
First PostedFeb 18, 2009
Enrollment StartApr 1, 2009
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.4 years ago
Interventions
metoclopramidedrug
30 minutes before meals and at bedtime for 4 weeks
Placebodrug
30 minutes before meals and at bedtime