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
sites
American Research Institute, Inc.
Cutler Bay, Florida 33157
2319
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Cutler Bay, FL
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DiscoveResearch, INC.
3420 Fannin
Beaumont, Texas 77701
409-813-1190
1422
mi
from 91732
Beaumont, TX
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
1777
mi
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Birmingham, AL
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
2189
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Chapel Hill, NC
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APF Research
1800 SW 1 ST #208
Miami, Florida 33135
2320
mi
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Miami, FL
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Clinical Trials of Texas, Inc.
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
1182
mi
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San Antonio, TX
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University of South Florida
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
2135
mi
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Tampa, FL
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Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina 28801
2002
mi
from 91732
Asheville, NC
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Summit Clinical Research, LLC
Athens, Georgia 30607
1967
mi
from 91732
Athens, GA
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University of Colorado Denver
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
825
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Aurora, CO
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Avant Research Associates LLC
Austin, Texas 78704
1212
mi
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Austin, TX
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Delta Research Partners, LLC
Bastrop, Louisiana 71220
1506
mi
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Bastrop, LA
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Dayton Gastroenterology
Beavercreek, Ohio 45440
1904
mi
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Beavercreek, OH
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Connecticut Clinical Research Foundation
Bristol, Connecticut 06010
2483
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Bristol, CT
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Hope Clinical Research, LLC
Canoga Park, California 91303
34
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Canoga Park, CA
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Biocon Clinical Research, LLC006
Caro, Michigan 48723
1958
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Caro, MI
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Del Sol Research Management, LLC
850 North Kolb Road
Chandler, Arizona 85224
433
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Chandler, AZ
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Carolinas Healthcare-Charlotte
Charlotte, North Carolina 28204
2101
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Charlotte, NC
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Innovative Research of West FL
Clearwater, Florida 33756
2117
mi
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Clearwater, FL
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Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
802
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Colorado Springs, CO
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Gastro Center of Maryland
Columbia, Maryland 21045
2289
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Columbia, MD
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Endocrinology Research Associates, Inc.
72 West 3rd Avenue
Columbus, Ohio 43201
1960
mi
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Columbus, OH
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Hometown Urgent Care and Research
4400 North High Street
Columbus, Ohio 43214
1959
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Columbus, OH
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PMG Research of Charlotte
Concord, North Carolina 28025
2114
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Concord, NC
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Kindred Medical Institute For Clinical Trials, LLC
Corona, California 92879
30
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Corona, CA
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Aurora Care Clinic
Costa Mesa, California 92627
29
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Costa Mesa, CA
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Top Medical Research, Inc.
Cutler Bay, Florida 33189
2319
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Cutler Bay, FL
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Digestive Health Specialist of the South East
480 Honeysuckle Road
Dothan, Alabama 36305
1897
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Dothan, AL
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AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey 08234
2409
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Egg Harbor Township, NJ
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Denver Esophageal and Stomach Center
Englewood, Colorado 80110
815
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Englewood, CO
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Medisphere Medical Research Center
Evansville, Indiana 47714
1717
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Evansville, IN
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Verity Research
Fairfax, Virginia 22031
2267
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Cumberland Research Associates
Fayetteville, North Carolina 28304
2208
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Valley View Wellness and Medical Center - VVCRD Clinical Research
Garden Grove, California 92845
21
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Garden Grove, CA
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Long Island Gastrointestinal Research Group, LLP
Great Neck, New York 11023
2446
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Great Neck, NY
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Triad Clinical Trials, LLC
Greensboro, North Carolina 27410
2151
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Greensboro, NC
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Gastroenterology Associates
Greenville, South Carolina 29615
2022
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Greenville, SC
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
2487
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Hamden, CT
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National Clinical LLC
6700 East Davison Street
Hamtramck, Michigan 48212
1968
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CroNOLA, LLC
Houma, Louisiana 70360
1626
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Houma, LA
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Amir Ali Hassan, MD, PA
11914 Astoria Boulevard
Houston, Texas 77089
1371
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Houston, TX
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Indiana University Health - University Hospital
Indianapolis, Indiana 46202
1793
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Indianapolis, IN
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Nature Coast Clinical Research
Inverness, Florida 34452
2122
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Inverness, FL
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University of Iowa Hospitals and Clinics
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
1528
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Mayo Clinic, Jacksonville
Jacksonville, Florida 32216
2135
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United Health Services Hospitals
33-57 Harrison Street
Johnson City, New York 13790
2328
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Johnson City, NY
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University of Kansas Medical Center
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
1332
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Kansas City, KS
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Nepean Hospital
Kingswood, New South Wales 2747
7535
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Kingswood,
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The University of California, San Diego
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
95
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Florida Research Institute
Lakewood Ranch, Florida 34211
2149
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Lakewood Ranch, FL
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Om Research
Lancaster, California 93534
43
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Palm Research Center
Las Vegas, Nevada 89102
217
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Clinical Research of South Nevada - CROSN
2755 East Desert Inn Road
Las Vegas, Nevada 89121
216
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Advanced Biomedical Research of America ABRA
Las Vegas, Nevada 89123
217
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Digestive Disease Specialists
Las Vegas, Nevada 89128
217
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Las Vegas, NV
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Family Medical Associates, Research Department
Levittown, Pennsylvania 19056
2392
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Levittown, PA
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CHI St. Vincent's Gastroenterology: John Tyler Baber, MD
1 Saint Vincent Circle
Little Rock, Arkansas 72205
1460
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Little Rock, AR
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University of Louisville
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
1812
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Cfagi Llc
Maitland, Florida 32751
2182
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New Orleans Research Institute - Metropolitan Gastroenterology Associates
1111 Medical Center Boulevard
Metairie, Louisiana 70006
1656
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Metairie, LA
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Advanced Medical Research Institute
8780 Southwest 8th Street
Miami, Florida 33174
2314
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Florida Research Center Inc.
10555 West Flagler Street
Miami, Florida 33174
2312
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AMPM Research Clinic
Miami, Florida 33145
2320
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Savin Medical Group LLC
5801 Northwest 151st Street
Miami Lakes, Florida 33014
2312
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Montana Medical Research
Missoula, Montana
908
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Missoula, MT
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West Virginia University
Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
2122
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Quality Medical Research Pllc
Nashville, Tennessee 37211
1766
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Weill-Cornell Medical College
New York, New York 10021
2434
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New York, NY
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Arkansas Gastorenterology
3401 Springhill Road
North Little Rock, Arkansas 72117
1466
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North Little Rock, AR
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Henry Ford Health System
Novi, Michigan 48377
1946
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Novi, MI
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Southwest Gastroenterology
Oak Lawn, Illinois 60453
1722
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Oak Lawn, IL
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Advanced Research Institute
Ogden, Utah 84405
590
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Ogden, UT
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Memorial Clinical Research
Oklahoma City, Oklahoma 73134
1165
mi
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Digestive Disease Specialists
3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
1161
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Diabetes & Endocrine Associates, PC
Omaha, Nebraska 68114
1301
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Omaha, NE
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Gulf Region Clinical Research Institute Llc
Pensacola, Florida 32514
1810
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Phoenix Clinical
Phoenix, Arizona 85021
341
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Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania 15243
2119
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Northwest Gastroenterology Clinic, LLC
Portland, Oregon 97210
829
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DHAT Research Institute
Richardson, Texas 75082
1229
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Infinite Clinical Trials
Riverdale, Georgia 30274
1920
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Pmg Research Of Salisbury
Salisbury, North Carolina 28144
2118
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Salisbury, NC
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SAGACT PLLC., San Antonio Gastroenterology Associates, PA
2833 Babcock Road
San Antonio, Texas 78229
1181
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Medical Associates Research Group
San Diego, California 92123
101
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Clinical Applications Laboratories Inc.
San Diego, California 92103
103
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Montgomery Medical, Inc.
Smithfield, Pennsylvania 15478
2130
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Smithfield, PA
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Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas 66606
1282
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Topeka, KS
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Troy Gastroenterology PC Center for Digestive Health
Troy, Michigan 48098
1962
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Troy, MI
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Del Sol Research Management
Tucson, Arizona 85710
435
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Upland Clinical Research
1060 East Foothill Boulevard
Upland, California 91786
21
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Family Practice Center Of Wadsworth, Inc.
Wadsworth, Ohio 44281
2029
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Advanced Clinical Research, Inc.
West Jordan, Utah 84088
559
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Boston V.A. Healthcare System
West Roxbury, Massachusetts 02132
2574
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Trial Management Associates LLC
Wilmington, North Carolina 28403
2275
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The Center for Clinical Research
Winston-Salem, North Carolina 27103
2123
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Wake Forest Baptist Health
Winston-Salem, North Carolina 27157
2126
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Cardinal Internal Medicine
Woodbridge, Virginia 22192
2271
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Gastroenterology Associates of Western Michigan
Wyoming, Michigan 49519
1837
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