Conditions: Diabetic Gastroparesis
Keywords: Gastroparesis Diabetic Delayed gastric emptying Gastric stasis Nausea Vomiting Bloating Abdominal pain Early satiety Gastropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 205
Healthy volunteers: no

Brief 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.

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: nasal spray formulation of metoclopramide intervention 2: nasal spray formulation with vehicle only

Protocol document: