Trials / Completed
CompletedNCT02025751
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
Phase 3 Companion Study of Intranasal Metoclopramide in Men With Symptomatic Diabetic Gastroparesis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Evoke Pharma · Industry
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Diabetic men with clinical symptoms attributed to diabetic gastroparesis and documentation of delayed gastric emptying who meet the protocol-specified entry criteria will be randomized to Metoclopramide Nasal Spray 10 mg or placebo administered as a single intranasal spray four (4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2016-08-01
- Completion
- 2016-10-01
- First posted
- 2014-01-01
- Last updated
- 2020-07-07
- Results posted
- 2020-07-07
Locations
49 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02025751. Inclusion in this directory is not an endorsement.