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Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis

Information source: Evoke Pharma
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastroparesis; Diabetic Gastroparesis; Diabetes; Diabetes Mellitus; Delayed Gastric Emptying

Intervention: metoclopramide (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Evoke Pharma

Summary

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.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Dose-Ranging Clinical Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Subjects With Gastroparesis

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary efficacy endpoint is the change from Baseline to the last 7 days during the treatment period in the average GCSI-DD total score, in subjects receiving metoclopramide nasal spray versus subjects receiving placebo.

Secondary outcome: Abdominal pain and discomfort, hours of nausea, vomiting episodes, daily overall symptom severity, PAGI-SYM, use of rescue medication between groups, SF-12, disability scores, and OGS severity and overall treatment scores by subject and investigator

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

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

Additional Information

Starting date: April 2009
Last updated: August 30, 2010

Page last updated: October 04, 2010

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