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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02025751
Other study ID # METO-IN-004
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2014
Est. completion date October 2016

Study information

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

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 53
Est. completion date October 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 75 Years
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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metoclopramide Nasal Spray
One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
Placebo Nasal Spray
One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)

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 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. Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population)
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