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

Information source: Evoke Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Gastroparesis

Intervention: Metoclopramide Nasal Spray (Drug); Placebo Nasal Spray (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Evoke Pharma

Official(s) and/or principal investigator(s):
Marilyn R Carlson, DMD, MD, Study Director, Affiliation: Evoke Pharma, Inc.

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.

Clinical Details

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

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

Primary outcome: Patient Reported Outcome (PRO) Symptom Diary

Secondary outcome: Population Pharmacokinetics

Detailed 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.

Eligibility

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

Criteria:

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

Locations and Contacts

Birmingham Gasteroenterology Associates, P.C., Birminham, Alabama 35209, United States; Recruiting
Sarah Ingle, Phone: 205-271-8000, Email: single@bgapc.com
John C Shallcross, MD, Principal Investigator

Digestive Specialists of the Southeast, Dothan, Alabama 36305, United States; Recruiting
Dawn Barnes, MSN, Phone: 334-836-3341, Email: dbarnes@dothangi.com
Samuel J Tarwater, MD, Principal Investigator

Clinical Research Associates, Huntsville, Alabama 35801, United States; Recruiting
Peg Rochine, Phone: 256-536-6600, Email: prochine@cra-al.biz
Allen Goetsch, MD, CPI, Principal Investigator

Central Arizone Medical Associates/Clinical Research Advantage, Mesa, Arizona 85206, United States; Recruiting
Marla Coury, Phone: 480-751-2490, Email: marlacoury@crastudies.com
David Tessler, MD, Principal Investigator

Preferred Research Partners, Little Rock, Arkansas 72211, United States; Recruiting
Jessica Watson, Phone: 501-553-9987, Ext: 106, Email: jwatson@preferredresearchpartners.com
John Baber, MD, Principal Investigator

Arkansas Gastroenterology, Sherwood, Arkansas 72120, United States; Recruiting
Stephanie Hogue, Phone: 501-945-9300, Email: stephaniehogue@arkgi.net
Gary Barton, MD, Principal Investigator

Precision Research Institute, LLC, Chula Vista, California 91910, United States; Recruiting
Joanna Garcia, Phone: 619-501-0371, Email: joanna@prisandiego.com
Cynthia Schaeffer, MD, Principal Investigator

John Muir Physician Network Clinical Research Center, Concord, California 94520, United States; Recruiting
Julie Fregosi, Phone: 925-687-8860, Email: julie.fregosi@johnmuirhealth.com
Anna Chang, MD, Principal Investigator

Precision Research Institute, LLC, San Diego, California 92114, United States; Recruiting
Joanna Garcia, Phone: 619-501-0371, Email: joanna@prisandiego.com
Taddese Desta, MD, Principal Investigator

The Center for Gastrointestinal Disorders, Hollywood, Florida 33021, United States; Recruiting
Deb Conte, Phone: 954-893-9222, Email: dconteccrc@outlook.com
Mark Lamet, MD, Principal Investigator

Nature Coast Clinical Research, Inverness, Florida 34452, United States; Recruiting
Stacy McCombs, RN, Phone: 352-341-2100, Email: smccombs@encoredocs.com
Paul Hellstern, MD, Principal Investigator

International Research Associates, LLC, Miami, Florida 33183, United States; Recruiting
Ilka Morales, Phone: 305-670-8830, Email: imorales@intrallc.com
Cristian Breton, MD, Principal Investigator

Advanced Medical Research, Port Orange, Florida 32127, United States; Recruiting
Saif Daghostani, Phone: 386-767-8800, Email: mdaghostani@amrcus.com
Ammar Hemaidan, MD, Principal Investigator

Tri-County Research, Athens, Georgia 30606, United States; Recruiting
Barbara Wilson, Phone: 706-227-6868, Email: bwilson@tricountytrials.com
Asif Qadri, MD, Principal Investigator

Digestive Healthcare of Georgia, Atlanta, Georgia 30309, United States; Recruiting
Debeeh Legaspi-Ringel, Phone: 404-355-3200, Ext: 1158, Email: dringle@digestivehealthcare.net
Michael Galambos, 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

Atlanta Gastroenterology Associates, Marietta, Georgia 30067, United States; Recruiting
Julie E. Johnson, Phone: 770-612-8165, Ext: 3613, Email: julie.johnson@atlantagastro.com
Michael LeVine, MD, Principal Investigator

Gastrointestinal Specialists of Georgia, PC, Marietta, Georgia 30060, United States; Recruiting
Janet Plumley, LPN, CCRC, Phone: 678-819-4221, Email: jplumley@gigeorgia.com
Aasim Sheikh, MD, Principal Investigator

Southwest Gastroenterology, Oak Lawn, Illinois 60453, United States; Recruiting
Arwa Kadiani, Phone: 708-560-7200, Email: arwak@dmclinicalresearch.com
Kamran Ayub, MD, Principal Investigator

Indiana University Health UH 1634, Indianapolis, Indiana 46202, United States; Recruiting
Anita Gupta, Phone: 317-948-9227, Email: anigupta@iu.edu
Thomas V. Nowak, MD, Principal Investigator

Professional Research Network of Kansas, Wichita, Kansas 67203, United States; Recruiting
Barb Loewen, RN, Phone: 316-838-7700, Email: info@prnofkansas.com
Dennis K. Buth, MD, Principal Investigator

Gastroenterology Associates, LLC, Baton Rouge, Louisiana 70809, United States; Recruiting
Regina Williams, Phone: 225-321-8737, Email: rwilliams@dhcla.com
Douglas Walsh, 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

Clinical Research Institute of Michigan, Chesterfield, Michigan 48047, United States; Recruiting
Tracy Jones, Phone: 586-598-3329, Email: tjones@researchmi.com
Karie Simons, Phone: 1-586-598-3329, Email: ksimons@researchmi.com
Ronald P. Fogel, MD, Principal Investigator

Center for Digestive Health, Troy, Michigan 48098, United States; Recruiting
Kim Baker, RN, BSN, Phone: 248-267-8485, Ext: 6606, Email: kbaker@troygastro.com
Richard Wille, MD, Principal Investigator

Gastroenterology Associates of Western Michigan, Wyoming, Michigan 49519, United States; Recruiting
Pamela Browder, Phone: 616-328-5319, Email: pbrowder@gastro-assoc-wm.com
Allan Coates, MD, Principal Investigator

Kansas City Gastroenterology & Hepatology, Kansas City, Missouri 64131, United States; Recruiting
Kelly Vargas, Phone: 816-759-5274, Email: kvargas@kcresearchinstitute.com
Bradley L. Freilich, MD, Principal Investigator

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Recruiting
Jessica I Chevalier, Phone: 603-653-9033, Email: Jessica.I.Chevalier@Hitchcock.org
Brian E. Lacy, MD, Principal Investigator

The Gastroenterology Group of South Jersey, Vineland, New Jersey 08360, United States; Recruiting
Allison Sacco, Phone: 856-691-1400, Email: asacco84@yahoo.com
Gary Matusow, DO, Principal Investigator

Lovelace Scientific Resources, Inc., Albuquerque, New Mexico 87108, United States; Recruiting
Leslie Byatt, Phone: 505-348-9500, Email: lbyatt@lrri.org
Michael McGuire, MD, Principal Investigator

Premier Medical Group of the Hudson, PC, Poughkeepsie, New York 12601, United States; Recruiting
Meggin Sabatino, Phone: 845-451-7225, Email: msabatino@premiermedicalhv.com
Alyson Cahill, MS, Phone: 845-451-7262, Email: acahill@premiermedicalhv.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
Brooke Shoffner, Phone: (910) 484-8163, Email: kshoffner@cumberlandresearchassociates.com
Valli Kodali, MD, Principal Investigator

LeBauer Research Associates, Greensboro, North Carolina 27406, United States; Recruiting
Carol Ward, Phone: 336-547-1739, Email: carol.ward@conehealth.com
Robert D. Kaplan, MD, Principal Investigator

Kinston Medical Specialist Clinical Research Office, Kinston, North Carolina 28501, United States; Recruiting
Wanda Small, Phone: 252-559-2200, Email: wanda.small@kinstonmd.com
Mark Marilley, MD, Principal Investigator

Wake Research Associates, Raleigh, North Carolina 27612, United States; Recruiting
Lauren Nelson, Phone: 919-781-2514, Email: lnelson@wakeresearch.com
Charles Barish, MD, Principal Investigator

PMG Research of Salisbury, Salisbury, North Carolina 28144, United States; Recruiting
Rene Rickard, Phone: 704-647-9575, Email: rrickard@pmg-research.com
Amy Pittman, Phone: 704-647-9575, Email: apittman@pmg-research.com
Kiran Jagarlamudi, MD, Principal Investigator

Piedmont Medical Research, Winston-Salem, North Carolina 27103, United States; Recruiting
Holly Smith, Phone: 336-768-8062, Email: hsmith@pmg-research.com
Robert J Holmes, MD, Principal Investigator

Dayton Gastroenterology, Beavercreek, Ohio 45440, United States; Recruiting
Alexandros Karabinis, Phone: 937-320-5050, Email: akarabinis@daytongastro.com
Larry W Weprin, MD, Principal Investigator

Temple University, Philadelphia, Pennsylvania 19140, United States; Recruiting
Amiya Palit, Phone: 215-707-7579, Email: amiya.palit@temple.edu
Henry P Parkman, MD, Principal Investigator

HCCA Clinical Research Solutions, Jackson, Tennessee 37805, United States; Recruiting
Vickie Grigsby, RN, Phone: 731-431-5027, Email: vgrigsby@crssites.com
Bob Souder, MD, Principal Investigator

Gastroenterology Associates, Kingsport, Tennessee 37660, United States; Recruiting
Kelly Ladd, CRC, Phone: 423-230-3154, Email: kelly_ladd@gastrotn.com
Douglas Homoky, MD, Principal Investigator

Quality Medical Research, Nashville, Tennessee 37211, United States; Recruiting
Christina Stahl, CRC, Phone: 615-835-4750, Email: cstahl@qualitymedicalresearch.com
Robert Herring, MD, Principal Investigator

Texas Clinical Research Institute, Arlington, Texas 76012, United States; Recruiting
Hector Alvarado, Phone: 817-471-1070, Email: hector463@gmail.com
M. Tarek Al-Assi, MD, Principal Investigator

Lovelace Scientific Resources, Austin, Texas 78758, United States; Recruiting
Sherri Jones, Phone: 512-901-8860, Email: sjones@lrri.org
Alice Friedman, MD, Principal Investigator

Texas Tech University Health Sciences Center, El Paso, Texas 79905, United States; Recruiting
Yvette Q. Gomez, Phone: 915-215-5218, Email: yvette.gomez@ttuhsc.edu
Richard McCallum, MD, Principal Investigator

Burke Internal Medicine, Burke, Virginia 22015, United States; Recruiting
Josefina Manalo, Phone: 703-455-9711, Email: phine213@msn.com
Nashwa Gabra, MD, Principal Investigator

Manassas Clinical Research, Manassas, Virginia 20110, United States; Recruiting
Jyotsna Sandil, Phone: 703-330-1112, Email: jyotsnasandil@yahoo.com
Nabil Andrawis, MD, Principal Investigator

National Clinical Research, Norfolk, Virginia 23502, United States; Recruiting
Sally Pepperman, Phone: 757-216-4100, Email: research@ncinc.net
Barry C Lubin, MD, Principal Investigator

Wisconsin Center for Advanced Research, Milwaukee, Wisconsin 53215, United States; Recruiting
Kathy Anderson, CMA,CCRC, Phone: 414-908-6630, Email: kathya@wigia.com
Daniel Geenen, MD, Principal Investigator

Additional Information

Starting date: April 2014
Last updated: June 27, 2015

Page last updated: August 23, 2015

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