Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis
NCT00845858 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 287
Last updated 2014-06-27
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.
Conditions
- Gastroparesis
- Diabetic Gastroparesis
- Diabetes
- Diabetes Mellitus
- Delayed Gastric Emptying
Interventions
- DRUG
-
metoclopramide
30 minutes before meals and at bedtime for 4 weeks
- DRUG
-
30 minutes before meals and at bedtime
Sponsors & Collaborators
-
Evoke Pharma
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-04-30
- Primary Completion
- 2011-12-31
- Completion
- 2011-12-31
Countries
- United States
Study Locations
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