Clinical trial NCT02025751: Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
Official title: Phase 3 Companion Study of Intranasal Metoclopramide in Men With Symptomatic Diabetic Gastroparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Gastroparesis
Keywords: Diabetes
Gastroparesis
Delayed gastric emptying
Nausea
Vomiting
Bloating
Abdominal pain
Early Satiety
Gastric stasis
Gastropathy
Lead sponsor: Evoke Pharma
Sponsor class: INDUSTRY
First posted: 2014-01-01
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure
timeFrame: Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Gasteroenterology Associates, P.C.
state: Alabama
city: Dothan
country: United States
facility: Digestive Specialists of the Southeast
state: Alabama
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Mesa
country: United States
facility: Central Arizone Medical Associates/Clinical Research Advantage
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Sherwood
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Chula Vista
country: United States
facility: Precision Research Institute, LLC
state: California
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: San Diego
country: United States
facility: Precision Research Institute, LLC
state: California
city: Hollywood
country: United States
facility: The Center for Gastrointestinal Disorders
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research
state: Florida
city: Athens
country: United States
facility: Tri-County Research
state: Georgia
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Conyers
country: United States
facility: Newton Medical Center
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Marietta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health UH 1634
state: Indiana
city: Wichita
country: United States
facility: Professional Research Network of Kansas
state: Kansas
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Gastroenterology & Hepatology
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Vineland
country: United States
facility: The Gastroenterology Group of South Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources, Inc.
state: New Mexico
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson, PC
state: New York
city: Fayetteville
country: United States
facility: Cumberland Research Associates
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Research Associates
state: North Carolina
city: Kinston
country: United States
facility: Kinston Medical Specialist Clinical Research Office
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Beavercreek
country: United States
facility: Dayton Gastroenterology
state: Ohio
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Jackson
country: United States
facility: HCCA Clinical Research Solutions
state: Tennessee
city: Kingsport
country: United States
facility: Gastroenterology Associates
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Austin
country: United States
facility: Lovelace Scientific Resources
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Burke
country: United States
facility: Burke Internal Medicine
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research
state: Virginia
city: Norfolk
country: United States
facility: National Clinical Research
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
affiliation: Evoke Pharma, Inc.
name: Marilyn R Carlson, DMD, MD
role: STUDY_DIRECTOR
References: