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

Use our guide to learn which trials are right for you!

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
49
sites
8200 SW 117th Ave # 210
Miami, Florida 33183
Principal Investigator: Cristian Breton, MD
Phone: 305-670-8830
?
mi
from
Miami, FL
Click here to add this to my saved trials
Albuquerque, New Mexico 87108
Principal Investigator: Michael McGuire, MD
Phone: 505-348-9500
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Arlington, Texas 76012
Principal Investigator: M. Tarek Al-Assi, MD
Phone: 817-471-1070
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Athens, Georgia 30606
Principal Investigator: Asif Qadri, MD
Phone: 706-227-6868
?
mi
from
Athens, GA
Click here to add this to my saved trials
Atlanta, Georgia 30309
Principal Investigator: Michael Galambos, MD
Phone: 404-355-3200
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78759
Principal Investigator: Alice Friedman, MD
Phone: 512-901-8860
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
Principal Investigator: Douglas Walsh, MD
Phone: 225-321-8737
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Beavercreek, Ohio 45440
Principal Investigator: Larry W Weprin, MD
Phone: 937-320-5050
?
mi
from
Beavercreek, OH
Click here to add this to my saved trials
1 Independence Plaza
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Burke, Virginia 22015
Principal Investigator: Nashwa Gabra, MD
Phone: 703-455-9711
?
mi
from
Burke, VA
Click here to add this to my saved trials
Chesterfield, Michigan 48098
Principal Investigator: Ronald P. Fogel, MD
Phone: 586-598-3329
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Chula Vista, California 91910
Principal Investigator: Cynthia Schaeffer, MD
Phone: 619-501-0371
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Concord, California 94520
Principal Investigator: Anna Chang, MD
Phone: 925-687-8860
?
mi
from
Concord, CA
Click here to add this to my saved trials
Conyers, Georgia 30013
Principal Investigator: Kaushik Amin, MD
Phone: 770-922-1778
?
mi
from
Conyers, GA
Click here to add this to my saved trials
Dothan, Alabama 36305
Principal Investigator: Samuel J Tarwater, MD
Phone: 334-836-3341
?
mi
from
Dothan, AL
Click here to add this to my saved trials
415 East Yandell Drive
El Paso, Texas 79905
Principal Investigator: Richard McCallum, MD
Phone: 915-215-5218
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
Principal Investigator: Valli Kodali, MD
Phone: 910-484-8163
?
mi
from
Fayetteville, NC
Click here to add this to my saved trials
Greensboro, North Carolina 27406
Principal Investigator: Robert D. Kaplan, MD
Phone: 336-547-1739
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Hollywood, Florida 33021
Principal Investigator: Mark Lamet, MD
Phone: 954-893-9222
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Huntsville, Alabama 35801
Principal Investigator: Allen Goetsch, MD, CPI
Phone: 256-536-6600
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: Thomas V. Nowak, MD
Phone: 317-948-9227
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Inverness, Florida 34452
Principal Investigator: Paul Hellstern, MD
Phone: 352-341-2100
?
mi
from
Inverness, FL
Click here to add this to my saved trials
Jackson, Tennessee 37805
Principal Investigator: Bob Souder, MD
Phone: 731-431-5027
?
mi
from
Jackson, TN
Click here to add this to my saved trials
Kansas City, Missouri 64131
Principal Investigator: Bradley L. Freilich, MD
Phone: 816-759-5274
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kingsport, Tennessee 37660
Principal Investigator: Douglas Homoky, MD
Phone: 423-230-3154
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
Kinston, North Carolina 28501
Principal Investigator: Mark Marilley, MD
Phone: 252-559-2200
?
mi
from
Kinston, NC
Click here to add this to my saved trials
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...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Little Rock, Arkansas 72211
Principal Investigator: John Baber, MD
Phone: 501-553-9987
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Manassas, Virginia 20110
Principal Investigator: Nabil Andrawis, MD
Phone: 703-330-1112
?
mi
from
Manassas, VA
Click here to add this to my saved trials
Marietta, Georgia 30060
Principal Investigator: Aasim Sheikh, MD
Phone: 678-819-4221
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Marietta, Georgia 30067
Principal Investigator: Michael LeVine, MD
Phone: 770-612-8165
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Mesa, Arizona 85206
Principal Investigator: David Tessler, MD
Phone: 480-751-2490
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Milwaukee, Wisconsin 53215
Principal Investigator: Daniel Geenen, MD
Phone: 414-908-6630
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Monroe, Louisiana 71201
Principal Investigator: Bal Raj Bhandari, MD
Phone: 318-807-0819
?
mi
from
Monroe, LA
Click here to add this to my saved trials
Nashville, Tennessee 37211
Principal Investigator: Robert Herring, MD
Phone: 615-835-4750
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Norfolk, Virginia
Principal Investigator: Barry C Lubin, MD
Phone: 757-216-4100
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oak Lawn, Illinois 60453
Principal Investigator: Kamran Ayub, MD
Phone: 708-560-7200
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
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...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Port Orange, Florida 32127
Principal Investigator: Ammar Hemaidan, MD
Phone: 386-767-8800
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
Poughkeepsie, New York 12601
Principal Investigator: Peter M Varunok, MD
Phone: 845-451-7225
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
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...
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Salisbury, North Carolina 28144
Principal Investigator: Kiran Jagarlamudi, MD
Phone: 704-647-9575
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
San Diego, California 92115
Principal Investigator: Taddese Desta, MD
Phone: 619-501-0371
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Sherwood, Arkansas 72120
Principal Investigator: Gary Barton, MD
Phone: 501-945-9300
?
mi
from
Sherwood, AR
Click here to add this to my saved trials
Troy, Michigan 48098
Principal Investigator: Richard Wille, MD
Phone: 248-267-8485
?
mi
from
Troy, MI
Click here to add this to my saved trials
Vineland, New Jersey 08360
Principal Investigator: Gary Matusow, DO
Phone: 856-691-1400
?
mi
from
Vineland, NJ
Click here to add this to my saved trials
Wichita, Kansas 67203
Principal Investigator: Dennis K. Buth, MD
Phone: 316-838-7700
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
Principal Investigator: Robert J Holmes, MD
Phone: 336-768-8062
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Wyoming, Michigan 49519
Principal Investigator: Allan Coates, MD
Phone: 616-328-5319
?
mi
from
Wyoming, MI
Click here to add this to my saved trials