Overview

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