Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Evoke Pharma
• Treatments: Metoclopramide

Criteria

Inclusion Criteria:

• Male subjects between the ages of 18 and 75 years

• Willingness and ability to give written informed consent

• The ability to read, understand and speak English

• Prior diagnosis of Type 1 or Type 2 diabetes

• Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying

• A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization

• Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study

Exclusion Criteria:

• Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility

• A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product

• A history of, or physical findings suggestive of, tardive dyskinesia

• A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening

• Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening

• Renal dysfunction calculated as creatinine clearance (CrCl) <40 mL/min at screening

• Hemoglobin A1c >11.5% at screening