Clinical trial NCT02025725: Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
Official title: Phase 3 Study of Intranasal Metoclopramide in Women With Symptomatic Diabetic Gastroparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Gastroparesis
Keywords: Gastroparesis
Diabetic
Delayed gastric emptying
Gastric stasis
Nausea
Vomiting
Bloating
Abdominal pain
Early satiety
Gastropathy
Lead sponsor: Evoke Pharma
Sponsor class: INDUSTRY
First posted: 2014-01-01
Enrollment: 205
Sex: FEMALE
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 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.

Eligibility criteria: Inclusion Criteria:

* Non pregnant, non lactating female 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
* Subjects of childbearing potential must agree to use contraception
* 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
* A history of allergy to any of the ingredients in the study drug formulation
* A history of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, active inflammatory bowel disease (IBD), or symptomatic irritable bowel syndrome (IBS)
* 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
* Subjects who are trying to conceive, are pregnant, or are lactating

Primary outcomes:
measure: Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure
timeFrame: Baseline Period to Week 4 of the Treatment Period
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: Jackson
country: United States
facility: Gastrointestional Associates
state: Mississippi
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: