Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis Study 02



Status:Recruiting
Conditions:Gastrointestinal, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:February 20, 2018
End Date:January 18, 2020
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@allergan.com
Phone:877-277-8566

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Trial Summary
Trial Overview
Inclusion Criteria

A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

This study will evaluate the safety and efficacy of Relamorelin compared to placebo in
patients with diabetic gastroparesis. Patients will report daily severity scores of their
diabetic gastroparesis symptoms.


Inclusion Criteria:

- Diagnosis of Type 1 or Type 2 diabetes mellitus

- Meet the per protocol criteria of diabetic gastroparesis

- Compliance with diary

- Compliance with the per protocol study treatment dosing instructions

Exclusion Criteria:

- Currently receiving nutrition intravenously, by nasogastric tube, or other feeding
tube

- History of an eating disorder (eg, anorexia nervosa, binge-eating, bulimia) in the
past 5 years

- Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity

- History of gastrointestinal disorders that may be similar to gasteroparisis

- Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
We found this trial at
97
sites
Texas Tech University Health Sciences, Center Division of Gastroenterology
4800 Alberta Avenue
El Paso, Texas 79905
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Emory University
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Kinston Medical Specialists
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico 87108
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HCP Clinical Research LLC
Anaheim, California 92801
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Texas Clinical Research Institute
Arlington, Texas 76012
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North Alabama Research Center
Athens, Alabama 35811
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Atlanta Diabetes Associates
Atlanta, Georgia 30309
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Visionary Investigators Network
Aventura, Florida 33180
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Delta Research Partners, LLC
Bastrop, Louisiana 71220
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Dayton Gasteroenterology,Inc.
75 Sylvania Drive
Beavercreek, Ohio 45440
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River Birch Research Alliance
Blue Ridge, Georgia 30513
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Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut 06606
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Commonwealth Clinical Studies
Brockton, Massachusetts 02302
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Gwinnett Research Institute
555 Old Norcross Road
Buford, Georgia 30519
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ClinRX Research LLC
6300 Stonewood Drive
Carrollton, Texas 75007
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Clinical Trials of South Carolina
Charleston, South Carolina 29406
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WR-ClinSearch, LLC
6035 Shallowford Road
Chattanooga, Tennessee 37421
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Clinical Research Institute of Michigan,
Chesterfield, Michigan 48098
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Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
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GW Research Inc,
Chula Vista, California 91910
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Leonard J. Dunn, MD
Clearwater, Florida 33765
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The MetroHealth System MHS
Cleveland, Ohio 44109
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Digestive Disease & Surgery Institute
9701 Euclid Avenue
Cleveland, Ohio 44195
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Aventiv Research
Columbus, Ohio 43213
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The Ohio State University, Wexner Medical Center
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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ALL Medical Research, LLC
Cooper City, Florida 33024
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Kindred Medical Institute For Clinical Trials, LLC
Corona, California 92879
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Tri-State Gastroenterology
425 Centre View Boulevard
Crestview Hills, Kentucky 41017
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Partners in Clinical Research, LLC
Cumberland, Rhode Island 02864
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Carolina Digestive Health Associates
Davidson, North Carolina 28036
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Clinical Inquest Center, Ltd.
Dayton, Ohio
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iResearch Atlanta LLC
Decatur, Georgia 30030
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TriWest Research Associates, LLC
El Cajon, California 92020
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Diagnamics Inc.
Encinitas, California 92024
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North Shore University Health System
Evanston, Illinois 60201
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Aa Mrc Llc
1201 Flushing Road
Flint, Michigan 48504
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G&L Research, LLC
Foley, Alabama 36535
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Gastroenterology Centers of the Midsouth
1324 Wolf Park Drive
Germantown, Tennessee 38138
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Woodholme Gastroenterology Associates, P.A.
Glen Burnie, Maryland 21061
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Long Island Gastrointestinal Research Group, LLP
Great Neck, New York 11023
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Meritus Center For Clinical Research
Hagerstown, Maryland 21740
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Palmetto Research
Hialeah, Florida 33016
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Vida Clinical Trials
830 North Krome Avenue
Homestead, Florida 33030
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Memorial Hermann Southeast Medical Plaza 1
11914 Astoria Boulevard
Houston, Texas 77089
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Biopharma Informatic Inc. Research Center
Houston, Texas 77043
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Rodriguez Clinical Trials
Houston, Texas 77083
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Baylor College of Medicine Medical Center
1 Baylor Plaza
Houston, Texas 77030
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Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho 83404
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American Research, LLC
Jeffersonville, Indiana 47130
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Sante Clinical Research
Kerrville, Texas 78028
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Clinical Trials of SWLA, LLC
1 Lakeshore Drive
Lake Charles, Louisiana 70601
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Preferred Research Partners, Inc.
Little Rock, Arkansas 72211
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Applied Research Center of Arkansas
Little Rock, Arkansas 72212
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Torrance Clinical Research Institute Inc.
Lomita, California 90717
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Tibor Rubin VA Medical Center
Long Beach, California 90822
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Angel City Research Inc.
Los Angeles, California 90057
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Blue Ridge Medical Research
Lynchburg, Virginia 24502
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Manassas Clinical Research Centre
Manassas, Virginia 20110
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Centro de Investigaciones Medicas Mar del Plata SRL
Mar del Plata, Buenos Aires
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Panax Clinical Research
Miami Lakes, Florida 33014
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Winthrop University Hospital
259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Facey Medical Foundation
Mission Hills, California 91345
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Alabama Medical Group, P.C.
6001 Airport Boulevard
Mobile, Alabama 36608
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Diabetes & Endocrinology Consultants
Morehead City, North Carolina 28557
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Gastroenterology Group of Naples
Naples, Florida 34102
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Gastroenterology of Southern Indiana
New Albany, Indiana 47150
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Arkansas Gastorenterology
3401 Springhill Road
North Little Rock, Arkansas 72117
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Diabetes & Endocrine Associates, PC
Omaha, Nebraska 68114
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Heartland Clinical Research, Inc.
Omaha, Nebraska 68134
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Stanford Hospital
Palo Alto, California 94305
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Univ of Pennsylvania
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania 15212
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Northwest Gastroenterology Clinic, LLC
Portland, Oregon 97210
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Health Science Research Center
Pratt, Kansas 67124
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Health Concepts
Rapid City, South Dakota 57702
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VA Medical Center McGuire VAMC
1201 Broad Rock Boulevard
Richmond, Virginia 23249
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Washington University in St. Louis
Saint Louis, Missouri 63110
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Sagact Pllc
San Antonio, Texas 78229
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Digestive Center of South Texas
621 Camden Street
San Antonio, Texas 78215
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Syrentis Clinical Research
Santa Ana, California 92705
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Guthrie Clinical Research
Sayre, Pennsylvania 18840
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Frontier Clinical Research, LLC
109 Crossroads Road
Scottdale, Pennsylvania 15683
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Texas Digestive Disease Consultantsc
Southlake, Texas 76092
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Southern Illinois University School of Medicine
801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
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Washington Gastroenterology, PLLC
Tacoma, Washington 98405
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Adobe Clinical Research, LLC
Tucson, Arizona 85712
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Options Health Research
Tulsa, Oklahoma 74137
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Preferred Primary Care Physicians
Uniontown, Pennsylvania 15401
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Clinical Trials of America, Inc.
210 Charlois Boulevard
West Monroe, Louisiana 71291
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Cleveland Clinic Florida - Weston
Weston, Florida 33331
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New Hope Research Development
Whittier, California 90603
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Professional Research Network of Kansas
Wichita, Kansas 67203
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Via Christi Clinic
Wichita, Kansas 67028
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Trial Management Associates LLC
Wilmington, North Carolina 28403
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PMG Research of Wilmington
1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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PMG Research of Winston-Salem
1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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