Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:8/30/2018
Start Date:September 2014
End Date:January 2016

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Trial Summary
Trial Overview
Inclusion Criteria

An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER
tablets during a treatment period of up to 24 weeks.


Inclusion Criteria:

- Subject completed participation in the TR02 study

- Subject is currently receiving in-center hemodialysis at the time of consent

Exclusion Criteria:

- Subject receiving or anticipated to be receiving nocturnal dialysis or home
hemodialysis treatment during the study

- Subject received opiates on a daily basis during the 1 week prior to screening

- Other than the TR02 Study Drug, Subject received any investigational drug within 4
weeks prior to Screening

- Subject is a pregnant or lactating female
We found this trial at
34
sites
Central Nephrology Medical Group
Bakersfield, California 93309
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Bakersfield, CA
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Pines Clinical Research, Inc.
Pembroke Pines, Florida 33028
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Pembroke Pines, FL
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Southwest Georgia Nephrology Clinic PC
Albany, Georgia 31701
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Albany, GA
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Renal Medicine Associates
Albuquerque, New Mexico 87109
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Albuquerque, NM
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Newtown Dialysis Center Inc
Astoria, New York 11102
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Astoria, NY
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North America Research Institute
Azusa, California 91702
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Azusa, CA
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Pegasus Dialysis Center
Bakersfield, California 93308
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Bakersfield, CA
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Nephrology Research Consortium
Bethlehem, Pennsylvania 18017
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Bethlehem, PA
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Nephrology Associates, P.C.
Birmingham, Alabama 35211
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Birmingham, AL
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Southeast Renal Research Institute
Chattanooga, Tennessee 37404
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Chattanooga, TN
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University of Cincinnati
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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Durham Nephrology Associates
Durham, North Carolina 27704
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Durham, NC
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Fresenius Medical Care of Evergreen Park
Evergreen Park, Illinois 60805
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Evergreen Park, IL
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U.S. Renal Care
Fort Worth, Texas 76105
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Fort Worth, TX
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Nephrology Center DBA, Paragon Health PC
Kalamazoo, Michigan 49007
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Kalamazoo, MI
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Kidney Associates of Kansas City PC
Kansas City, Missouri 64131
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Kansas City, MO
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Renal Physicians of Georgia
Macon, Georgia 31217
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Macon, GA
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U.S. Renal Care Inc
Mansfield, Texas 76063
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Mansfield, TX
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McComb Limited Care Facility
McComb, Mississippi 39648
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McComb, MS
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Pacific Renal Research Institute
Meridian, Idaho 83642
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Meridian, ID
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Nephrology & Hypertension Associates PC
Middlebury, Connecticut 06762
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Middlebury, CT
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University of South Alabama Medical Center
Mobile, Alabama 36604
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Mobile, AL
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Nephrology-Hypertension Associates of Central New Jersey PA
North Brunswick, New Jersey 80902
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North Brunswick, NJ
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Dialysis Clinic, Inc.
Philadelphia, Pennsylvania 19140
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Philadelphia, PA
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Delaware Valley Nephrology
Philadelphia, Pennsylvania 19118
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Philadelphia, PA
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Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona 85012
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Phoenix, AZ
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U.S. Renal Care Inc
Pine Bluff, Arkansas 76103
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Pine Bluff, AR
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Wake Nephrology Associates PA
Raleigh, North Carolina 27609
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Raleigh, NC
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Western New England Renal and Transplant Association
Springfield, Massachusetts 01107
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Springfield, MA
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Carolina Diabetes & Kidney Center
Sumter, South Carolina 29150
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Sumter, SC
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Genesis Clinical Research, Inc.
Tampa, Florida 33614
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Tampa, FL
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Mark Lee MD, Inc
Whittier, California 90606
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Whittier, CA
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Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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DaVita Central Orlando Dialysis
Winter Park, Florida 32789
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Winter Park, FL
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