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

Diabetic Gastroparesis Clinical Trial

Official title:

Phase 3 Study of Intranasal Metoclopramide in Women With Symptomatic Diabetic Gastroparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025725
• Other study ID #: METO-IN-003
• Status: Completed
• Phase: Phase 3
• Start date: March 27, 2014
• Est. completion date: June 27, 2016

Study information

• Verified date: June 2020
• Source: Evoke Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: June 27, 2016
• Est. primary completion date: May 27, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

Intervention

Drug:
• Metoclopramide Nasal Spray
nasal spray formulation of metoclopramide
• Placebo Nasal Spray
nasal spray formulation with vehicle only

Locations

Country	Name	City	State
United States	Lovelace Scientific Resources, Inc.	Albuquerque	New Mexico
United States	Texas Clinical Research Institute	Arlington	Texas
United States	Tri-County Research	Athens	Georgia
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	Lovelace Scientific Resources	Austin	Texas
United States	Gastroenterology Associates, LLC	Baton Rouge	Louisiana
United States	Dayton Gastroenterology	Beavercreek	Ohio
United States	Birmingham Gasteroenterology Associates, P.C.	Birmingham	Alabama
United States	Burke Internal Medicine	Burke	Virginia
United States	Clinical Research Institute of Michigan	Chesterfield	Michigan
United States	Precision Research Institute, LLC	Chula Vista	California
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	Newton Medical Center	Conyers	Georgia
United States	Digestive Specialists of the Southeast	Dothan	Alabama
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	Cumberland Research Associates	Fayetteville	North Carolina
United States	LeBauer Research Associates	Greensboro	North Carolina
United States	The Center for Gastrointestinal Disorders	Hollywood	Florida
United States	Clinical Research Associates	Huntsville	Alabama
United States	Indiana University Health UH 1634	Indianapolis	Indiana
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Gastrointestional Associates	Jackson	Mississippi
United States	HCCA Clinical Research Solutions	Jackson	Tennessee
United States	Kansas City Gastroenterology & Hepatology	Kansas City	Missouri
United States	Gastroenterology Associates	Kingsport	Tennessee
United States	Kinston Medical Specialist Clinical Research Office	Kinston	North Carolina
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Preferred Research Partners	Little Rock	Arkansas
United States	Manassas Clinical Research	Manassas	Virginia
United States	Atlanta Gastroenterology Associates	Marietta	Georgia
United States	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	Central Arizone Medical Associates/Clinical Research Advantage	Mesa	Arizona
United States	International Research Associates, LLC	Miami	Florida
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Delta Research Partners, LLC	Monroe	Louisiana
United States	Quality Medical Research	Nashville	Tennessee
United States	National Clinical Research	Norfolk	Virginia
United States	Southwest Gastroenterology	Oak Lawn	Illinois
United States	Temple University	Philadelphia	Pennsylvania
United States	Advanced Medical Research	Port Orange	Florida
United States	Premier Medical Group of the Hudson, PC	Poughkeepsie	New York
United States	Wake Research Associates	Raleigh	North Carolina
United States	PMG Research of Salisbury	Salisbury	North Carolina
United States	Precision Research Institute, LLC	San Diego	California
United States	Arkansas Gastroenterology	Sherwood	Arkansas
United States	Center for Digestive Health	Troy	Michigan
United States	The Gastroenterology Group of South Jersey	Vineland	New Jersey
United States	Professional Research Network of Kansas	Wichita	Kansas
United States	Piedmont Medical Research	Winston-Salem	North Carolina
United States	Gastroenterology Associates of Western Michigan	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Evoke Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure	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.	Baseline Period to Week 4 of the Treatment Period