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.
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.
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
Vineland, New Jersey 08360
Principal Investigator: Gary Matusow, DO
Phone: 856-691-1400
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8200 SW 117th Ave # 210
Miami, Florida 33183
Miami, Florida 33183
Principal Investigator: Cristian Breton, MD
Phone: 305-670-8830
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Albuquerque, New Mexico 87108
Principal Investigator: Michael McGuire, MD
Phone: 505-348-9500
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Arlington, Texas 76012
Principal Investigator: M. Tarek Al-Assi, MD
Phone: 817-471-1070
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Athens, Georgia 30606
Principal Investigator: Asif Qadri, MD
Phone: 706-227-6868
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Atlanta, Georgia 30309
Principal Investigator: Michael Galambos, MD
Phone: 404-355-3200
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Austin, Texas 78759
Principal Investigator: Alice Friedman, MD
Phone: 512-901-8860
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Baton Rouge, Louisiana 70809
Principal Investigator: Douglas Walsh, MD
Phone: 225-321-8737
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Beavercreek, Ohio 45440
Principal Investigator: Larry W Weprin, MD
Phone: 937-320-5050
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Burke, Virginia 22015
Principal Investigator: Nashwa Gabra, MD
Phone: 703-455-9711
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Chesterfield, Michigan 48098
Principal Investigator: Ronald P. Fogel, MD
Phone: 586-598-3329
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Chula Vista, California 91910
Principal Investigator: Cynthia Schaeffer, MD
Phone: 619-501-0371
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Concord, California 94520
Principal Investigator: Anna Chang, MD
Phone: 925-687-8860
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Conyers, Georgia 30013
Principal Investigator: Kaushik Amin, MD
Phone: 770-922-1778
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Dothan, Alabama 36305
Principal Investigator: Samuel J Tarwater, MD
Phone: 334-836-3341
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415 East Yandell Drive
El Paso, Texas 79905
El Paso, Texas 79905
Principal Investigator: Richard McCallum, MD
Phone: 915-215-5218
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Fayetteville, North Carolina 28304
Principal Investigator: Valli Kodali, MD
Phone: 910-484-8163
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Greensboro, North Carolina 27406
Principal Investigator: Robert D. Kaplan, MD
Phone: 336-547-1739
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Hollywood, Florida 33021
Principal Investigator: Mark Lamet, MD
Phone: 954-893-9222
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Huntsville, Alabama 35801
Principal Investigator: Allen Goetsch, MD, CPI
Phone: 256-536-6600
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Indianapolis, Indiana 46202
Principal Investigator: Thomas V. Nowak, MD
Phone: 317-948-9227
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Inverness, Florida 34452
Principal Investigator: Paul Hellstern, MD
Phone: 352-341-2100
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Jackson, Tennessee 37805
Principal Investigator: Bob Souder, MD
Phone: 731-431-5027
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Kansas City, Missouri 64131
Principal Investigator: Bradley L. Freilich, MD
Phone: 816-759-5274
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Kingsport, Tennessee 37660
Principal Investigator: Douglas Homoky, MD
Phone: 423-230-3154
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Kinston, North Carolina 28501
Principal Investigator: Mark Marilley, MD
Phone: 252-559-2200
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1 Medical Center Dr
Lebanon, New Hampshire 03756
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...
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Little Rock, Arkansas 72211
Principal Investigator: John Baber, MD
Phone: 501-553-9987
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Manassas, Virginia 20110
Principal Investigator: Nabil Andrawis, MD
Phone: 703-330-1112
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Marietta, Georgia 30060
Principal Investigator: Aasim Sheikh, MD
Phone: 678-819-4221
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Marietta, Georgia 30067
Principal Investigator: Michael LeVine, MD
Phone: 770-612-8165
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Mesa, Arizona 85206
Principal Investigator: David Tessler, MD
Phone: 480-751-2490
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Milwaukee, Wisconsin 53215
Principal Investigator: Daniel Geenen, MD
Phone: 414-908-6630
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Monroe, Louisiana 71201
Principal Investigator: Bal Raj Bhandari, MD
Phone: 318-807-0819
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Nashville, Tennessee 37211
Principal Investigator: Robert Herring, MD
Phone: 615-835-4750
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Norfolk, Virginia
Principal Investigator: Barry C Lubin, MD
Phone: 757-216-4100
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Oak Lawn, Illinois 60453
Principal Investigator: Kamran Ayub, MD
Phone: 708-560-7200
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1801 N Broad St
Philadelphia, Pennsylvania 19122
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...
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Port Orange, Florida 32127
Principal Investigator: Ammar Hemaidan, MD
Phone: 386-767-8800
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Poughkeepsie, New York 12601
Principal Investigator: Peter M Varunok, MD
Phone: 845-451-7225
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
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...
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Salisbury, North Carolina 28144
Principal Investigator: Kiran Jagarlamudi, MD
Phone: 704-647-9575
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San Diego, California 92115
Principal Investigator: Taddese Desta, MD
Phone: 619-501-0371
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Sherwood, Arkansas 72120
Principal Investigator: Gary Barton, MD
Phone: 501-945-9300
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Troy, Michigan 48098
Principal Investigator: Richard Wille, MD
Phone: 248-267-8485
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Wichita, Kansas 67203
Principal Investigator: Dennis K. Buth, MD
Phone: 316-838-7700
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Winston-Salem, North Carolina 27103
Principal Investigator: Robert J Holmes, MD
Phone: 336-768-8062
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Wyoming, Michigan 49519
Principal Investigator: Allan Coates, MD
Phone: 616-328-5319
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