Trials / Completed
CompletedNCT02025725
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
Phase 3 Study of Intranasal Metoclopramide in Women With Symptomatic Diabetic Gastroparesis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 205 (actual)
- Sponsor
- Evoke Pharma · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Diabetic women 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 | nasal spray formulation of metoclopramide |
| DRUG | Placebo Nasal Spray | nasal spray formulation with vehicle only |
Timeline
- Start date
- 2014-03-27
- Primary completion
- 2016-05-27
- Completion
- 2016-06-27
- First posted
- 2014-01-01
- Last updated
- 2020-07-07
- Results posted
- 2020-02-11
Locations
50 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02025725. Inclusion in this directory is not an endorsement.