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

Status:	Completed
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 75
Updated:	6/29/2018
Start Date:	April 2014
End Date:	October 2016

Phase 3 Companion Study of Intranasal Metoclopramide in Men With Symptomatic Diabetic Gastroparesis

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.

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.

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

We found this trial at

sites

Kansas City Gastroenterology & Hepatology

Kansas City, Missouri 64131

Principal Investigator: Bradley L. Freilich, MD

Phone: 816-759-5274

from

Kansas City, MO

International Research Associates

8200 SW 117th Ave # 210
Miami, Florida 33183

Principal Investigator: Cristian Breton, MD

Phone: 305-670-8830

from

Miami, FL

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico 87108

Principal Investigator: Michael McGuire, MD

Phone: 505-348-9500

from

Albuquerque, NM

Texas Clinical Research Institute

Arlington, Texas 76012

Principal Investigator: M. Tarek Al-Assi, MD

Phone: 817-471-1070

from

Arlington, TX

Tri-County Research

Athens, Georgia 30606

Principal Investigator: Asif Qadri, MD

Phone: 706-227-6868

from

Athens, GA

Digestive Healthcare of Georgia

Atlanta, Georgia 30309

Principal Investigator: Michael Galambos, MD

Phone: 404-355-3200

from

Atlanta, GA

Lovelace Scientific Resources

Austin, Texas 78759

Principal Investigator: Alice Friedman, MD

Phone: 512-901-8860

from

Austin, TX

Gastroenterology Associates

Baton Rouge, Louisiana 70809

Principal Investigator: Douglas Walsh, MD

Phone: 225-321-8737

from

Baton Rouge, LA

Dayton Gastroenterology

Beavercreek, Ohio 45440

Principal Investigator: Larry W Weprin, MD

Phone: 937-320-5050

from

Beavercreek, OH

Birmingham Gasteroenterology Associates, P.C.

1 Independence Plaza
Birmingham, Alabama 35209

from

Birmingham, AL

Burke Internal Medicine, Inc.

Burke, Virginia 22015

Principal Investigator: Nashwa Gabra, MD

Phone: 703-455-9711

from

Burke, VA

Clinical Research Institute of Michigan,

Chesterfield, Michigan 48098

Principal Investigator: Ronald P. Fogel, MD

Phone: 586-598-3329

from

Chesterfield, MI

Precision Research Institute

Chula Vista, California 91910

Principal Investigator: Cynthia Schaeffer, MD

Phone: 619-501-0371

from

Chula Vista, CA

John Muir Physician Network Clinical Research Center

Concord, California 94520

Principal Investigator: Anna Chang, MD

Phone: 925-687-8860

from

Concord, CA

Newton Medical Center

Conyers, Georgia 30013

Principal Investigator: Kaushik Amin, MD

Phone: 770-922-1778

from

Conyers, GA

Digestive Specialists of the Southeast

Dothan, Alabama 36305

Principal Investigator: Samuel J Tarwater, MD

Phone: 334-836-3341

from

Dothan, AL

Texas Tech University Health Sciences Center

415 East Yandell Drive
El Paso, Texas 79905

Principal Investigator: Richard McCallum, MD

Phone: 915-215-5218

from

El Paso, TX

Cumberland Research Associates

Fayetteville, North Carolina 28304

Principal Investigator: Valli Kodali, MD

Phone: 910-484-8163

from

Fayetteville, NC

LeBauer Research Associates

Greensboro, North Carolina 27406

Principal Investigator: Robert D. Kaplan, MD

Phone: 336-547-1739

from

Greensboro, NC

Center for Gastrointestinal Disorders

Hollywood, Florida 33021

Principal Investigator: Mark Lamet, MD

Phone: 954-893-9222

from

Hollywood, FL

Clinical Research Associates

Huntsville, Alabama 35801

Principal Investigator: Allen Goetsch, MD, CPI

Phone: 256-536-6600

from

Huntsville, AL

Indiana University Health UH 1634

Indianapolis, Indiana 46202

Principal Investigator: Thomas V. Nowak, MD

Phone: 317-948-9227

from

Indianapolis, IN

Nature Coast Clinical Research

Inverness, Florida 34452

Principal Investigator: Paul Hellstern, MD

Phone: 352-341-2100

from

Inverness, FL

HCCA Clinical Research Solutions

Jackson, Tennessee 37805

Principal Investigator: Bob Souder, MD

Phone: 731-431-5027

from

Jackson, TN

Gastroenterology Associates

Kingsport, Tennessee 37660

Principal Investigator: Douglas Homoky, MD

Phone: 423-230-3154

from

Kingsport, TN

Kinston Medical Specialist Clinical Research Office

Kinston, North Carolina 28501

Principal Investigator: Mark Marilley, MD

Phone: 252-559-2200

from

Kinston, NC

Dartmouth Hitchcock Medical Center

1 Medical Center Dr
Lebanon, New Hampshire 03756

(603) 650-5000

Principal Investigator: Brian E. Lacy, MD

Phone: 603-653-9033

Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...

from

Lebanon, NH

Preferred Research Partners, Inc.

Little Rock, Arkansas 72211

Principal Investigator: John Baber, MD

Phone: 501-553-9987

from

Little Rock, AR

Manassas Clinical Research

Manassas, Virginia 20110

Principal Investigator: Nabil Andrawis, MD

Phone: 703-330-1112

from

Manassas, VA

Gastrointestinal Specialists of Georgia

Marietta, Georgia 30060

Principal Investigator: Aasim Sheikh, MD

Phone: 678-819-4221

from

Marietta, GA

Atlanta Gastroenterology Associates, LLC

Marietta, Georgia 30067

Principal Investigator: Michael LeVine, MD

Phone: 770-612-8165

from

Marietta, GA

Central Arizone Medical Associates/Clinical Research Advantage

Mesa, Arizona 85206

Principal Investigator: David Tessler, MD

Phone: 480-751-2490

from

Mesa, AZ

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin 53215

Principal Investigator: Daniel Geenen, MD

Phone: 414-908-6630

from

Milwaukee, WI

Delta Research Partners, LLC

Monroe, Louisiana 71201

Principal Investigator: Bal Raj Bhandari, MD

Phone: 318-807-0819

from

Monroe, LA

Quality Medical Research Pllc

Nashville, Tennessee 37211

Principal Investigator: Robert Herring, MD

Phone: 615-835-4750

from

Nashville, TN

National Clinical Research

Norfolk, Virginia

Principal Investigator: Barry C Lubin, MD

Phone: 757-216-4100

from

Norfolk, VA

Southwest Gastroenterology

Oak Lawn, Illinois 60453

Principal Investigator: Kamran Ayub, MD

Phone: 708-560-7200

from

Oak Lawn, IL

Temple University

1801 N Broad St
Philadelphia, Pennsylvania 19122

(215) 204-7000

Principal Investigator: Henry P Parkman, MD

Phone: 215-707-7579

Temple University Temple University is many things to many people. A place to pursue life's...

from

Philadelphia, PA

Advanced Medical Research

Port Orange, Florida 32127

Principal Investigator: Ammar Hemaidan, MD

Phone: 386-767-8800

from

Port Orange, FL

Premier Medical Group of the Hudson, PC

Poughkeepsie, New York 12601

Principal Investigator: Peter M Varunok, MD

Phone: 845-451-7225

from

Poughkeepsie, NY

Wake Research Associates, LLC

3100 Duraleigh Rd
Raleigh, North Carolina 27612

(919) 781-2514

Principal Investigator: Charles Barish, MD

Phone: 919-781-2514

Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...

from

Raleigh, NC

Pmg Research Of Salisbury

Salisbury, North Carolina 28144

Principal Investigator: Kiran Jagarlamudi, MD

Phone: 704-647-9575

from

Salisbury, NC

Precision Research Institute, LLC

San Diego, California 92115

Principal Investigator: Taddese Desta, MD

Phone: 619-501-0371

from

San Diego, CA

Arkansas Gastroenterology

Sherwood, Arkansas 72120

Principal Investigator: Gary Barton, MD

Phone: 501-945-9300

from

Sherwood, AR

Center for Digestive Health

Troy, Michigan 48098

Principal Investigator: Richard Wille, MD

Phone: 248-267-8485

from

Troy, MI

The Gastroenterology Group of South Jersey

Vineland, New Jersey 08360

Principal Investigator: Gary Matusow, DO

Phone: 856-691-1400

from

Vineland, NJ

Professional Research Network of Kansas

Wichita, Kansas 67203

Principal Investigator: Dennis K. Buth, MD

Phone: 316-838-7700

from

Wichita, KS

Piedmont Medical Research, LLC.

Winston-Salem, North Carolina 27103

Principal Investigator: Robert J Holmes, MD

Phone: 336-768-8062

from

Winston-Salem, NC

Gastroenterology Associates of Western Michigan

Wyoming, Michigan 49519

Principal Investigator: Allan Coates, MD

Phone: 616-328-5319

from

Wyoming, MI

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

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Phase 3 Companion Study of Intranasal Metoclopramide in Men With Symptomatic Diabetic Gastroparesis

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