Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/30/2019
Start Date:June 17, 2015
End Date:July 29, 2020
Contact:Receptos True North Study
Email:truenorth@quintiles.com
Phone:1-844-266-9299

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

The purpose of this study is to determine whether RPC1063 is effective in the treatment of
Ulcerative Colitis (UC).

The trial is composed of 2 periods: Induction and Maintenance. Patients will be entered into
the trial in 2 separate cohorts through the Induction Period (10 weeks) and those patients in
clinical response at the end of the Induction Period will proceed through to the Maintenance
Period. Participation in these periods will be 52 weeks. Patients may also qualify to
participate in an optional Open-Label Extension study.

Key Inclusion Criteria:

- Ulcerative Colitis (UC) confirmed on endoscopy

- Moderately to severely active UC (Mayo score 6-12)

- Currently receiving treatment with aminosalisylate, prednisone, or budesonide

Key Exclusion Criteria:

- Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a
fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or
ischemic colitis

- Clinically relevant cardiovascular conditions or other relevant diseases that could
impact the implementation or interpretation of the trial, or put the patient at risk

- History of uveitis macular edema

- Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG)
measured during Screening
We found this trial at
111
sites
Om Research
Lancaster, California 93534
1149
mi
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Lancaster, CA
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Montefiore Medical Center
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
1293
mi
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Bronx, NY
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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...
1038
mi
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Chapel Hill, NC
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Gastroenterology Associates of Tidewater
112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
1186
mi
from
Chesapeake, VA
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Brooke Army Medical Center
3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
574
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Indiana University Hospital
550 University Boulevard
Indianapolis, Indiana 46202
642
mi
from
Indianapolis, IN
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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...
1133
mi
from
Kinston, NC
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University of Kentucky Medical Center
740 South Limestone Street
Lexington, Kentucky 40536
725
mi
from
Lexington, KY
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
618
mi
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Nashville, TN
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Hospital of the University of Pennsylvania
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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1223
mi
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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
1383
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Portland, OR
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University of Utah
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
777
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Salt Lake City, UT
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Gastroenterology, Ltd.
1101 First Colonial Road
Virginia Beach, Virginia 23454
757-481-4817
1196
mi
from
Virginia Beach, VA
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Anaheim Clinical Trials, LLC
1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
1155
mi
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Anaheim, CA
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University of Michigan Health System
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
808
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Ann Arbor, MI
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Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina 28801
857
mi
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Asheville, NC
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Atlanta Gastroenterology Associates
Atlanta, Georgia 30342
798
mi
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Atlanta, GA
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University of Maryland Medical Group
22 South Greene Street
Baltimore, Maryland 21201
1148
mi
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Baltimore, MD
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Johns Hopkins Clinical Research Network
1800 Orleans Street
Baltimore, Maryland 21287
1149
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Baltimore, MD
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Woodholme Gastroenterology
Baltimore, Maryland 21208
1148
mi
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Baltimore, MD
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Gastroenterology Associates
Baton Rouge, Louisiana 70809
637
mi
from
Baton Rouge, LA
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Ehrhardt Clinical Research, LLC
Belton, Missouri 64012
192
mi
from
Belton, MO
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Boston Med Ctr
Boston, Massachusetts 02118
1443
mi
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Boston, MA
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Clinical Research Professionals, LLC - De Paul Medical Dr
Bridgeton, Missouri 63044
407
mi
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Bridgeton, MO
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Commonwealth Clinical Studies
Brockton, Massachusetts 02302
1445
mi
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Brockton, MA
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NY Scientific
2001 Oriental Boulevard
Brooklyn, New York 11235
1290
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Brooklyn, NY
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Hospital Italiano
4190 Juan D. Peron
Buenos Aires, C1181
5601
mi
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Buenos Aires,
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Carolinas HealthCare System Digestive Health
1025 Morehead Medical Drive
Charlotte, North Carolina 28204
958
mi
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Charlotte, NC
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University of Virginia
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
1049
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Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
1124
mi
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Chevy Chase, MD
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Northwestern University Feinberg Sch of Medicine Division of Gastroenterology
Chicago, Illinois 60611
?
mi
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Chicago, IL
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University of Chicago Medical Center
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
609
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UC Health Clinical Trials Office
Cincinnati, Ohio 45206
728
mi
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Cincinnati, OH
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Clinical Research of West Florida - Clearwater
Clearwater, Florida 33765
1100
mi
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Clearwater, FL
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Gastro Florida
Clearwater, Florida 33762
1108
mi
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Clearwater, FL
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Gastro Center of Maryland
Columbia, Maryland 21045
1136
mi
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Columbia, MD
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Consultants in Gastroenterology
Columbia, South Carolina 29203
972
mi
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Columbia, SC
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Ohio State University Clinical Trials Management Office
Columbus, Ohio
810
mi
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Columbus, OH
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Aurora Care Clinic
Costa Mesa, California 92627
1160
mi
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Costa Mesa, CA
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Baylor Research Institute
3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
347
mi
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Dallas, TX
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Advanced Pharma Research, Inc
Delray Beach, Florida 33445
?
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Delray Beach, FL
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Dolphin Medical Research
Doral, Florida 33172
1311
mi
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Doral, FL
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Universal Axon Clinical Research, LLC
3650 Northwest 82nd Avenue
Doral, Florida 33166
1313
mi
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Doral, FL
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Ventavia Research Group, LLC
Fort Worth, Texas 76104
348
mi
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Fort Worth, TX
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Valley View Internal Medicine
Garden Grove, California 92843
1158
mi
from
Garden Grove, CA
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Gastro One
Germantown, Tennessee 38138
481
mi
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Germantown, TN
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Long Island Clinical Research Associates
Great Neck, New York 11021
1301
mi
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Great Neck, NY
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
1345
mi
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Hamden, CT
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Gulf Coast Research Group LLC
Houston, Texas 77004
572
mi
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Houston, TX
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The Methodist Hospital Research Institute
Houston, Texas 77030
572
mi
from
Houston, TX
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Houston Endoscopy and Research Center
Houston, Texas 77079
565
mi
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Houston, TX
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Davita Clinical Trials, LLC
Huntington Beach, California 92646
?
mi
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Huntington Beach, CA
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Grand Teton Research Group
Idaho Falls, Idaho 83404
839
mi
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Idaho Falls, ID
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East Carolina Gastroenterology
Jacksonville, North Carolina 28546
1153
mi
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Jacksonville, NC
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University of California, San Diego Medical Center
La Jolla, California 92093
1118
mi
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La Jolla, CA
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Florida Center for Gastroenterology
Largo, Florida 33777
1103
mi
from
Largo, FL
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Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire 03756
1392
mi
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Lebanon, NH
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Gastrointestinal Biosciences
Los Angeles, California 90067
1177
mi
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Los Angeles, CA
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Southern California Research Institute Medical Group Inc
Los Angeles, California 90045
1168
mi
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Los Angeles, CA
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University of Southern California- Keck School of Medicine
Los Angeles, California 90033
1166
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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...
656
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Dean Foundation for Health, Research and Education Inc.
Madison, Wisconsin 53715
575
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Madison, WI
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Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
788
mi
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Marietta, GA
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Community Clinical Research Network
Marlborough, Massachusetts 01752
1419
mi
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Marlborough, MA
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Great Lakes Gastroenterology Research
Mentor, Ohio 44060
915
mi
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Mentor, OH
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City Medical Group
1611 Northwest 12th Avenue
Miami, Florida 33130
1319
mi
from
Miami, FL
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Advanced Clinical Research of Miami
Miami, Florida 33155
1317
mi
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Miami, FL
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Regenerate Clinical Trials
Miami, Florida 33155
1321
mi
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Miami, FL
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Advanced Clincial Research
Miami, Florida 33134
?
mi
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Miami, FL
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Facey Medical Foundation (Parent)
15451 San Fernando Mission Boulevard
Mission Hills, California 91345
1176
mi
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Mission Hills, CA
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Advanced Research for Health Improvement, LLC
1168 Goodlette-Frank Road
Naples, Florida 34102
1231
mi
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Naples, FL
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Advanced Research Institute, Inc
New Port Richey, Florida
1096
mi
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New Port Richey, FL
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NSB Research
New Smyrna Beach, Florida 32174
1144
mi
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New Smyrna Beach, FL
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Icahn School of Medicine Mount Sinai Beth Isreal
New York, New York 10003
?
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New York, NY
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Weill-Cornell Medical College
New York, New York 10021
1289
mi
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New York, NY
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Mount Sinai - PRIME
New York, New York 10029
1290
mi
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New York, NY
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Concord Medical Group PRIME
New York, New York 10016
1225
mi
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New York, NY
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New York University School of Medicine
550 1st Ave
New York, New York 10016
(212) 263-7300
New York University School of Medicine NYU School of Medicine has a proud history that...
1288
mi
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New York, NY
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Arkansas Gastroenterology
North Little Rock, Arkansas
371
mi
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North Little Rock, AR
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Med-Care Research
North Miami Beach, Florida 33162
1314
mi
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North Miami Beach, FL
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Harmony Clinical Research, Inc.
North Miami Beach, Florida 33162
1314
mi
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North Miami Beach, FL
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DM Clinical Research
Oak Lawn, Illinois 60453
600
mi
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Oak Lawn, IL
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Alliance Clinical Research
Oceanside, California 92056
1138
mi
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Oceanside, CA
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University of Oklahoma
1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
158
mi
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Oklahoma City, OK
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Digestive Disease Specialists
3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
154
mi
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Oklahoma City, OK
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Gastroenterology Associates of Orangeburg, PA
Orangeburg, South Carolina 29118
995
mi
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Orangeburg, SC
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Center For Digestive Health
Orlando, Florida 32803
1141
mi
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Orlando, FL
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IMIC
Palmetto Bay, Florida
1322
mi
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Palmetto Bay, FL
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Theia Clinical Research
4820 Park Boulevard North
Pinellas Park, Florida 33781
1111
mi
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Pinellas Park, FL
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The Mayo Clinic
Rochester, Minnesota 55905
515
mi
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Rochester, MN
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PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina 27804
1112
mi
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Rocky Mount, NC
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Washington University
Saint Louis, Missouri 63110
413
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Saint Louis, MO
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Clinical Research Professionals LLC - The Pines Court
Saint Louis, Missouri 63141
418
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Saint Louis, MO
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Clinical Research Professionals, LLC - Olde Cabin Rd
11457 Olde Cabin Road
Saint Louis, Missouri 63141
405
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Saint Louis, MO
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Gastroenterology Research Of San Antonio
San Antonio, Texas 78229
576
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San Antonio, TX
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San Antonio Gastroenterology
520 East Euclid Avenue
San Antonio, Texas 78212
575
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San Antonio, TX
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Medical Associates Research Group
San Diego, California 92123
1139
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San Diego, CA
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University of California at San Francisco (PARENT)
1710 Scott Street
San Francisco, California 94115
1340
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University of Washington Medical Center
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
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1410
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Benaroya Research Institute at Virginia Mason
Seattle, Washington 98101
1410
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Seattle, WA
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Texas Digestive Disease Consultants - Southlake
505 Nolen Drive
Southlake, Texas 76092
335
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Southlake, TX
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