A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis



Status:Recruiting
Conditions:Gastrointestinal, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:September 29, 2017
End Date:November 23, 2019
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 gastroparesis

- Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
We found this trial at
98
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Florida Research Institute
Lakewood Ranch, Florida 34211
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DiscoveResearch, INC.
3420 Fannin
Beaumont, Texas 77701
409-813-1190
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
(919) 962-2211
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APF Research
1800 SW 1 ST #208
Miami, Florida 33135
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Clinical Trials of Texas, Inc.
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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University of South Florida
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina 28801
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Summit Clinical Research, LLC
Athens, Georgia 30607
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University of Colorado Denver
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
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Avant Research Associates LLC
Austin, Texas 78704
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Delta Research Partners, LLC
Bastrop, Louisiana 71220
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Dayton Gastroenterology
Beavercreek, Ohio 45440
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Connecticut Clinical Research Foundation
Bristol, Connecticut 06010
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Hope Clinical Research, LLC
Canoga Park, California 91303
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Biocon Clinical Research, LLC006
Caro, Michigan 48723
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Del Sol Research Management, LLC
850 North Kolb Road
Chandler, Arizona 85224
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Carolinas Healthcare-Charlotte
Charlotte, North Carolina 28204
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Innovative Research of West FL
Clearwater, Florida 33756
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Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
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Gastro Center of Maryland
Columbia, Maryland 21045
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Endocrinology Research Associates, Inc.
72 West 3rd Avenue
Columbus, Ohio 43201
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Hometown Urgent Care and Research
4400 North High Street
Columbus, Ohio 43214
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PMG Research of Charlotte
Concord, North Carolina 28025
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Kindred Medical Institute For Clinical Trials, LLC
Corona, California 92879
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Aurora Care Clinic
Costa Mesa, California 92627
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American Research Institute, Inc.
Cutler Bay, Florida 33157
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Top Medical Research, Inc.
Cutler Bay, Florida 33189
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Digestive Health Specialist of the South East
480 Honeysuckle Road
Dothan, Alabama 36305
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AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey 08234
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Denver Esophageal and Stomach Center
Englewood, Colorado 80110
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Medisphere Medical Research Center
Evansville, Indiana 47714
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Verity Research
Fairfax, Virginia 22031
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Cumberland Research Associates
Fayetteville, North Carolina 28304
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Valley View Wellness and Medical Center - VVCRD Clinical Research
Garden Grove, California 92845
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Long Island Gastrointestinal Research Group, LLP
Great Neck, New York 11023
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Triad Clinical Trials, LLC
Greensboro, North Carolina 27410
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Gastroenterology Associates
Greenville, South Carolina 29615
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
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National Clinical LLC
6700 East Davison Street
Hamtramck, Michigan 48212
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CroNOLA, LLC
Houma, Louisiana 70360
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Amir Ali Hassan, MD, PA
11914 Astoria Boulevard
Houston, Texas 77089
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Indiana University Health - University Hospital
Indianapolis, Indiana 46202
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Nature Coast Clinical Research
Inverness, Florida 34452
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University of Iowa Hospitals and Clinics
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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Mayo Clinic, Jacksonville
Jacksonville, Florida 32216
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United Health Services Hospitals
33-57 Harrison Street
Johnson City, New York 13790
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University of Kansas Medical Center
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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Nepean Hospital
Kingswood, New South Wales 2747
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The University of California, San Diego
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
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Om Research
Lancaster, California 93534
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Palm Research Center
Las Vegas, Nevada 89102
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Clinical Research of South Nevada - CROSN
2755 East Desert Inn Road
Las Vegas, Nevada 89121
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Advanced Biomedical Research of America ABRA
Las Vegas, Nevada 89123
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Digestive Disease Specialists
Las Vegas, Nevada 89128
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Family Medical Associates, Research Department
Levittown, Pennsylvania 19056
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CHI St. Vincent's Gastroenterology: John Tyler Baber, MD
1 Saint Vincent Circle
Little Rock, Arkansas 72205
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University of Louisville
500 S Preston St
Louisville, Kentucky
(502) 852-5555
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Cfagi Llc
Maitland, Florida 32751
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New Orleans Research Institute - Metropolitan Gastroenterology Associates
1111 Medical Center Boulevard
Metairie, Louisiana 70006
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Advanced Medical Research Institute
8780 Southwest 8th Street
Miami, Florida 33174
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Florida Research Center Inc.
10555 West Flagler Street
Miami, Florida 33174
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AMPM Research Clinic
Miami, Florida 33145
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Savin Medical Group LLC
5801 Northwest 151st Street
Miami Lakes, Florida 33014
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Montana Medical Research
Missoula, Montana
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West Virginia University
Morgantown, West Virginia 26506
(304) 293-0111
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Quality Medical Research Pllc
Nashville, Tennessee 37211
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Weill-Cornell Medical College
New York, New York 10021
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Arkansas Gastorenterology
3401 Springhill Road
North Little Rock, Arkansas 72117
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Henry Ford Health System
Novi, Michigan 48377
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Southwest Gastroenterology
Oak Lawn, Illinois 60453
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Advanced Research Institute
Ogden, Utah 84405
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Memorial Clinical Research
Oklahoma City, Oklahoma 73134
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Digestive Disease Specialists
3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
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Diabetes & Endocrine Associates, PC
Omaha, Nebraska 68114
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Gulf Region Clinical Research Institute Llc
Pensacola, Florida 32514
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Phoenix Clinical
Phoenix, Arizona 85021
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Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania 15243
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Northwest Gastroenterology Clinic, LLC
Portland, Oregon 97210
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DHAT Research Institute
Richardson, Texas 75082
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Infinite Clinical Trials
Riverdale, Georgia 30274
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Pmg Research Of Salisbury
Salisbury, North Carolina 28144
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SAGACT PLLC., San Antonio Gastroenterology Associates, PA
2833 Babcock Road
San Antonio, Texas 78229
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Medical Associates Research Group
San Diego, California 92123
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Clinical Applications Laboratories Inc.
San Diego, California 92103
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Montgomery Medical, Inc.
Smithfield, Pennsylvania 15478
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Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas 66606
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Troy Gastroenterology PC Center for Digestive Health
Troy, Michigan 48098
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Del Sol Research Management
Tucson, Arizona 85710
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Upland Clinical Research
1060 East Foothill Boulevard
Upland, California 91786
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Family Practice Center Of Wadsworth, Inc.
Wadsworth, Ohio 44281
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Advanced Clinical Research, Inc.
West Jordan, Utah 84088
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Boston V.A. Healthcare System
West Roxbury, Massachusetts 02132
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Trial Management Associates LLC
Wilmington, North Carolina 28403
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The Center for Clinical Research
Winston-Salem, North Carolina 27103
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Wake Forest Baptist Health
Winston-Salem, North Carolina 27157
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Cardinal Internal Medicine
Woodbridge, Virginia 22192
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Gastroenterology Associates of Western Michigan
Wyoming, Michigan 49519
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