To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray
solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic
gastroparesis.
Inclusion Criteria
1. Male subjects and non-pregnant, non-lactating female subjects between the ages of 18
and 75 years (inclusive)
2. Willing and able to give written informed consent to participate in the study
3. Ability to read and understand English
4. Diagnosis of Type 1 or Type 2 diabetes
5. Diagnosis of diabetic gastroparesis previously documented
6. A mean daily GCSI-DD score of ≥2 and ≤4 for the 7 days prior to the Randomization
Visit (Visit 3, Day 0)
7. Female subjects of childbearing potential, defined as not surgically sterile or at
least 2 years postmenopausal, must agree to use one of the following forms of
contraception from Screening through the last dose of study drug: hormonal (oral,
implant, or injection) begun >30 days prior to screening, barrier (condom, diaphragm,
or cervical cap with spermicide), intrauterine device (IUD), or vasectomized partner
(6-months minimum)
8. No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results (with the exception of lipid profile, glucose
and hemoglobin A1c) during screening which, in the opinion of the Investigator, would
jeopardize the safety of the subject or impact the validity of the study results
9. Willingness to discontinue current treatment for diabetic gastroparesis and to avoid
all medications specified by the protocol for the duration of the study
Exclusion Criteria
1. Gastric bypass and gastric banding, gastric pacemakers, post-surgical causes of
gastroparesis and disorders known to be associated with abnormal gastrointestinal
motility such as active gastric ulcer, active duodenal ulcer, active severe
gastritis, gastric cancer, amyloidosis, neuromuscular diseases (including Parkinson's
disease), collagen vascular diseases, alcoholism, uremia, malnutrition, and untreated
hypothyroidism
2. 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
3. History of or physical findings suggestive of tardive dyskinesia
4. Currently using and unwilling or unable to stop any medication known to be associated
with tardive dyskinesia (See Study Reference Manual) prior to Washout (Visit 2)
5. History of allergy to any of the ingredients in the study drug formulation;
metoclopramide, citric acid, sodium citrate, benzalkonium chloride, EDTA, or sorbitol
6. History of organ transplant, chronic pancreatitis, gross malabsorptive syndromes,
celiac disease, or inflammatory bowel disease
7. Malignancy (with the exception of basal cell carcinoma of the skin) currently
present, initially diagnosed or recurring within 5 years of enrollment
8. History of other clinically significant renal, hepatic, neurologic, hematologic,
oncologic, pulmonary, psychiatric, cardiovascular or infectious disease, or any other
condition which, in the opinion of the Investigator, would jeopardize the safety of
the subject or impact the validity of the study results
9. Have renal dysfunction calculated as creatinine clearance (CrCl) < 40 mL/min at
Screening (Visit 1)
10. Have a hemoglobin A1c > 12. 5% at Screening (Visit 1)
11. Inability or unwillingness to stop using the following agents for 7 days during the
Washout Period (Day - 7 to Day -1) prior to Randomization (Visit 3, Day 0) and refrain
from their use for the 4-week study period; oral and parenteral formulations of
metoclopramide, domperidone, tricyclic antidepressants, macrolide antibiotics,
prokinetic agents, cholinergic agents, agents with significant anticholinergic
effects, narcotic analgesics, orally administered β agonists, spasmolytics, dopamine
agonists, monoamine oxidase inhibitors, herbal supplements, fiber or bulking
products, and laxatives
12. Use of neurotoxins (e. g., botulinum type A or B) as a treatment for gastroparesis or
delayed gastric emptying within 6 months of Screening (Visit 1)
13. Clinically significant abnormal finding or a QTc interval >450 milliseconds (msec) on
ECGs obtained at Screening (Visit 1) OR pre- or post-dose at Randomization (Visit 3)
14. Inability or unwillingness to stop using medications associated with Torsades de
Pointes or a prolonged QT interval for 30 days prior to the initial symptom
assessment and refrain from their use for the 4-week study period (see Study
Reference Manual)
15. Female subjects who are trying to conceive, are pregnant, or are lactating
16. Positive serum human chorionic gonadotropin (HCG) pregnancy test at Screening or a
positive HCG urine test on Day 0 prior to administration of study drug for women of
childbearing potential
17. History of alcohol or drug abuse within the year prior to the Screening Visit, or
current known evidence of substance dependence or abuse
18. Participation in a clinical (investigational) trial or receipt of a non-FDA approved
therapy within 30 days prior to the Screening Visit (Visit 1) with the exception of
domperidone
Digestive Specialists of the Southeast, Dothan, Alabama 36305, United States; Recruiting
Carol Williams, Phone: 334-596-1732, Email: cwilliams@dothangi.com
Samuel Tarwater, MD, Principal Investigator
Medical Affiliated Research Center, Inc., Huntsville, Alabama 35801, United States; Recruiting
LuAnne Boggs, Phone: 256-533-6603, Email: jgm@marc-research.com
Suresh Karne, MD, Principal Investigator
Clinical Research Associates, Huntsville, Alabama 35801, United States; Recruiting
Erin McCulley, Phone: 256-536-6600, Email: emcculley@cra-al.biz
Allen Goetsch, MD, CPI, Principal Investigator
Desert Sun Gastroenterology, Tucson, Arizona 85710, United States; Recruiting
Wendy Hotz, R.Ph., Phone: 520-481-8464, Email: whotz@dsgastro.com
Craig Glen Gross, MD, Principal Investigator
Clopton Clinic, Jonesboro, Arkansas 72401, United States; Recruiting
Paige Holcomb, RN, CCRC, Phone: 870-530-6796, Email: pholcomb@clinicalresearchconnections.com
Barry Garner, MD, Principal Investigator
Arkansas Gastroenterology, Sherwood, Arkansas 72120, United States; Recruiting
Amie Crow, LPN, Phone: 501-835-7100, Email: amie@arkgi.net
Gary Barton, MD, Principal Investigator
Robert M. Karns, MD, a Medical Corporation, Beverly Hills, California 90211, United States; Recruiting
Jackie M. Bral, MD, ACRPCCRC, Phone: 310-652-8084, Email: jmorenobral@sbcglobal.net
Nicholas Karyotakis, MD, Principal Investigator
VA Long Beach Healthcare System, Long Beach, California 90822, United States; Recruiting
Lea Liu, Phone: 526-826-5058, Email: lea.liu@va.gov
M. Mazen Jamal, MD, MPH, Principal Investigator
Impact Clinical Trials, Los Angeles, California 90036, United States; Recruiting
Rocio Rodriguez, Phone: 310-289-8242, Ext: 173, Email: rrodriguez@impactla.org
Lydie Hazan, MD, Principal Investigator
Prime-Care Clinical Research, Mission Viejo, California 92691, United States; Terminated
Infosphere Clinical Research, Inc., West Hills, California 91307, United States; Recruiting
Edith Sisneros, Phone: 818-346-5820, Email: edith@infosphere.com
Dan A. Streja, MD, Principal Investigator
Westlake Medical Research, Westlake Village, California 91361, United States; Completed
Consultants for Clinical Research of South Florida, Boynton Beach, Florida 33426, United States; Recruiting
Mary Lu Sullivan-Wells, Phone: 561-732-9722, Email: mwells@ccrstudy.com
Madeleine DuPree, MD, Principal Investigator
Innovative Research of West Florida, Inc., Clearwater, Florida 33756, United States; Completed
Nature Coast Clinical Research, Inverness, Florida 34452, United States; Completed
Borland-Groover Clinic, Jacksonville, Florida 32256, United States; Recruiting
Sara Benner, Phone: 904-680-0871, Email: sbenner@bgclinic.com
Kyle Etzkorn, MD, Principal Investigator
International Research Associates, LLC, Miami, Florida 33183, United States; Recruiting
Yeline Gomez, Phone: 305-670-8830, Email: ygomez@intrallc.com
Cristian F Breton, MD, Principal Investigator
AppleMed Research, Inc., Miami, Florida 33155, United States; Recruiting
Carlos Manzano, Phone: 305-667-8434, Email: c26applemed@aol.com
Leonel Perez-Limonte, MD, Principal Investigator
Newton Medical Center, Conyers, Georgia 30013, United States; Recruiting
Sunil Khetarpal, Phone: 770-922-1778, Email: khetarpal_sunil@hotmail.com
Kaushik Amin, MD, Principal Investigator
Gastrointestinal Specialists of Georgia, Marietta, Georgia 30060, United States; Recruiting
Janet Plumley, LPN, CCRC, Phone: 678-819-4221, Email: jplumley@dcapc.com
Ross Kommor, MD, Principal Investigator
Rockford Gastroenterology Associates, Rockford, Illinois 61107, United States; Recruiting
Kathy Geissler, RN, Phone: 815-484-7804, Email: kgeissler@rockfordgi.com
Robert L. Barclay, MD, Principal Investigator
Saint John's Research Institute, Anderson, Indiana 46016, United States; Recruiting
Lisa Ruehr, Phone: 765-648-4106, Email: lhruehr@sjhsnet.org
Thomas Nowak, MD, Principal Investigator
Cotton-O'Neil Clinical Research Center, Topeka, Kansas 66606, United States; Completed
Professional Research Network of Kansas, Wichita, Kansas 67203, United States; Recruiting
Cindy James, Phone: 316-838-7700, Email: cjames@prnofkansas.com
Dennis Buth, MD, Principal Investigator
Delta Research Partners, LLC, Monroe, Louisiana 71201, United States; Recruiting
Melissa McCullars, Phone: 318-807-0819, Email: mmccullars@gastromds.com
Bal Raj Bhandari, MD, Principal Investigator
Metropolitan Gastroenterology Group, Chevy Chase, Maryland 20815, United States; Recruiting
Amina Oughourli, Phone: 301-652-5520, Email: amina.oughourli@capitaldigestivecare.com
Robert Hardi, MD, Principal Investigator
Maryland Digestive Disease Research, LLC, Laurel, Maryland 20707, United States; Recruiting
Maureen Bates, RN, Phone: 240-554-0384, Email: mbates@mddisease.com
Christopher Shih, MD, Principal Investigator
Endoscopic Microsurgery Associates, Towson, Maryland 21204, United States; Recruiting
Jennifer Hudgins, Phone: 410-494-1846, Email: jhudgins@gastro-doc.ocm
Mark Noar, MD, Principal Investigator
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Completed
Plymouth Clinic, Plymouth, Minnesota 55446, United States; Completed
CRC of Jackson, LLC, Jackson, Mississippi 39202, United States; Completed
Gastrointestional Associates, Jackson, Mississippi 39202, United States; Completed
Digestive Health Specialists, Tupelo, Mississippi 38801, United States; Recruiting
Vanessa Miller, Phone: 662-680-5565, Email: vmiller@nmhs.net
Stephen Amann, MD, Principal Investigator
Kansas City Gastroenterology & Hepatology, Kansas City, Missouri 64131, United States; Recruiting
Laurie Lynn, Phone: 816-285-0103, Email: laurie@digestivenet.com
Bradley L. Freilich, MD, Principal Investigator
Center for Digestive and Liver Diseases, Inc., Mexico, Missouri 65265, United States; Recruiting
Amy Bakke, Phone: 573-581-7196, Email: amy@gutdoc.us
Glenn L Gordon, MD,FACP,FACG, Principal Investigator
Lovelace Scientific Resources, Inc., Albuquerque, New Mexico 87108, United States; Recruiting
Melissa Garcia, Phone: 505-348-9523, Email: mlgarcia@lrri.org
Martin Conway, MD, Principal Investigator
Research Associates of New York, New York, New York 10075, United States; Recruiting
Nicole St. Vrestil, Phone: 212-996-1105, Email: nicole.stvrestil@nyga.md
Lawrence B Cohen, Principal Investigator
Medex Healthcare Research, Inc., New York, New York 10004, United States; Completed
Gastroenterology Associates, Poughkeepsie, New York 12601, United States; Recruiting
Lainey Rudolph, RN, Phone: 845-471-9410, Email: lrudolphrn@hudsonvalleygi.com
Peter M. Varunok, MD, Principal Investigator
Cumberland Research Associates, Fayetteville, North Carolina 28304, United States; Recruiting
Loretta Joyce, Phone: 910-484-8163, Email: ljoyce@cumberlandresearchassociates.com
Valli Kodali, MD, Principal Investigator
LeBauer Research Associates, Greensboro, North Carolina 27406, United States; Recruiting
Carol Ward, Phone: 336-323-3229, Email: carol.ward@mosescone.com
Robert Kaplan, MD, Principal Investigator
Wake Research Associates, Raleigh, North Carolina 27612, United States; Recruiting
Eugenio Nalian, Phone: 919-781-2514, Email: enalian@wakeresearch.com
Charles Barish, MD, Principal Investigator
Hanover Medical Specialists, Wilmington, North Carolina 28401, United States; Recruiting
Cindy Nadherny, Phone: 910-763-0131, Email: cnadherny@hmsdocs.com
Frederick Opper, MD, Principal Investigator
Piedmont Medical Research, Winston-Salem, North Carolina 27103, United States; Recruiting
Cindy Dillard, Phone: 336-714-2620, Email: cdillard@pmg-research.com
Robert Holmes, MD, Principal Investigator
AGA, Akron, Ohio 44302, United States; Completed
Hightop Medical Research Center, Cincinnati, Ohio 45224, United States; Completed
Consultants for Clinical Research, Cincinnati, Ohio 45211, United States; Recruiting
Marcel Lanton, Phone: 513-872-4549, Email: mlanton@ccrstudy.com
Timothy McCarren, MD, Principal Investigator
Great Lakes Gastroenterology, Mentor, Ohio 44060, United States; Recruiting
Debbie Donahue, RN, Phone: 440-205-1225, Email: msubouffy@hotmail.com
Keith Friedenberg, MD, Principal Investigator
Regional Gastroenterology Associates of Lancaster, Ltd., Lancaster, Pennsylvania 17604, United States; Recruiting
Christina Edsall, RN, CCRC, Phone: 717-544-3404, Email: edsall@rgal.com
Daniel C. Connell, Jr., MD, Principal Investigator
PMA Medical Specialists, Limerick, Pennsylvania 19468, United States; Completed
Memphis Gastroenterology Group, Germantown, Tennessee 38138, United States; Completed
Medical Specialty Clinic Research, Jackson, Tennessee 38301, United States; Completed
HCCA Clinical Research Solutions, Jackson, Tennessee 37805, United States; Recruiting
Vickie Grigsby, RN, Phone: 731-431-5027, Email: vgrigsby@hccacrs.com
Allen Menachem, MD, Principal Investigator
Holston Medical Group, PC, Kingsport, Tennessee 37660, United States; Completed
Lovelace Scientific Resources, Austin, Texas 78759, United States; Recruiting
Luisa Sansalone, BSc, Phone: 512-901-8860, Email: lsansalone@lrri.org
Paul Moore, MD, Principal Investigator
Jacinto Medical Group, Baytown (Houston), Texas 77521, United States; Completed
Dynamed Clinical Research, Houston, Texas 77034, United States; Recruiting
Crystal Rangel, Phone: 281-517-0550, Email: crystal@dmclinicalresearch.com
Natarajan Bala, MD, Principal Investigator
Digestive Health Associates of Texas, P.A., Plano, Texas 75075, United States; Recruiting
Luz Stella Muniz, MD, CCRC, Phone: 972-265-3406, Email: luz.muniz@dhat.com
Kenneth Joseph Brown, MD, Principal Investigator
Theda Oaks Endoscopy Center, San Antonio, Texas 78258, United States; Recruiting
Andrea Pena, Phone: 210-268-0126, Email: apena@thedaoaks.com
Joycelyn Theard, MD, Principal Investigator
Trinity Health Care, Tyler, Texas 75702, United States; Completed
Charlottesville Medical Research, Charlottesville, Virginia 22911, United States; Completed
Gastroenterology Associates of Tidewater, Chesapeake, Virginia 23320, United States; Completed
Digestive and Liver Disease Specialists, Norfolk, Virginia 23502, United States; Recruiting
Skeeter Holmes, Phone: 757-961-1126, Email: research@dlds.org
David A. Johnson, MD, Principal Investigator
Gastroenterology, Ltd., Virginia Beach, Virginia 23454, United States; Recruiting
Ryan Marie Diduk, MPH, Phone: 757-481-4817, Ext: 3308, Email: rdiduk@gastroltd.com
David H. Stockwell, MD, Principal Investigator
Wisconsin Center for Advanced Research, Milwaukee, Wisconsin 53215, United States; Recruiting
Brenda Giesen, BS, CRC, Phone: 414-908-6630, Email: brendagi@wigia.com
Daniel Geenen, MD, Principal Investigator
