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

Phase 3

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Metoclopramide Nasal Spray	Metoclopramide Nasal Spray	Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Placebo Nasal Spray	Placebo Nasal Spray	Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks

Primary Outcome Measures

Name	Time	Method
Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure	Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population)	Change from the Baseline Period to Week 4 of the Treatment Period in the mean daily Gastroparesis Symptom Assessment (GSA) total score for subjects receiving Metoclopramide Nasal Spray 10 mg versus subjects receiving placebo. The GSA minimum value is 0 (no symptoms) and the maximum value is 4 (very severe symptoms). A higher score is a worse outcome.

Secondary Outcome Measures

Name	Time	Method

Locations (48): Birmingham Gasteroenterology Associates, P.C.
🇺🇸
Birmingham, Alabama, United States
Digestive Specialists of the Southeast
🇺🇸
Dothan, Alabama, United States
Clinical Research Associates
🇺🇸
Huntsville, Alabama, United States
Central Arizone Medical Associates/Clinical Research Advantage
🇺🇸
Mesa, Arizona, United States
Preferred Research Partners
🇺🇸
Little Rock, Arkansas, United States
Arkansas Gastroenterology
🇺🇸
Sherwood, Arkansas, United States
Precision Research Institute, LLC
🇺🇸
San Diego, California, United States
John Muir Physician Network Clinical Research Center
🇺🇸
Concord, California, United States
The Center for Gastrointestinal Disorders
🇺🇸
Hollywood, Florida, United States
Nature Coast Clinical Research
🇺🇸
Inverness, Florida, United States
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Birmingham Gasteroenterology Associates, P.C.
🇺🇸Birmingham, Alabama, United States