Conditions: Diabetic Gastroparesis
Keywords: Diabetes Gastroparesis Delayed gastric emptying Nausea Vomiting Bloating Abdominal pain Early Satiety Gastric stasis Gastropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks arm 2: Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks

Interventions: intervention 1: Metoclopramide Nasal Spray intervention 2: Placebo Nasal Spray
Intervention descriptions: intervention 1: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID) intervention 2: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)

Protocol document: