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
U.S. Renal Care Inc
Pine Bluff, Arkansas 76103
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Pine Bluff, AR
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Pines Clinical Research, Inc.
Pembroke Pines, Florida 33028
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from
Pembroke Pines, FL
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Southwest Georgia Nephrology Clinic PC
Albany, Georgia 31701
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from
Albany, GA
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Renal Medicine Associates
Albuquerque, New Mexico 87109
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from
Albuquerque, NM
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Newtown Dialysis Center Inc
Astoria, New York 11102
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from
Astoria, NY
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North America Research Institute
Azusa, California 91702
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from
Azusa, CA
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Pegasus Dialysis Center
Bakersfield, California 93308
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Bakersfield, CA
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Central Nephrology Medical Group
Bakersfield, California 93309
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Bakersfield, CA
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Nephrology Research Consortium
Bethlehem, Pennsylvania 18017
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from
Bethlehem, PA
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Nephrology Associates, P.C.
Birmingham, Alabama 35211
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from
Birmingham, AL
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Southeast Renal Research Institute
Chattanooga, Tennessee 37404
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from
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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mi
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Cincinnati, OH
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Durham Nephrology Associates
Durham, North Carolina 27704
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from
Durham, NC
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Fresenius Medical Care of Evergreen Park
Evergreen Park, Illinois 60805
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from
Evergreen Park, IL
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U.S. Renal Care
Fort Worth, Texas 76105
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from
Fort Worth, TX
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Nephrology Center DBA, Paragon Health PC
Kalamazoo, Michigan 49007
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from
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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from
Macon, GA
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U.S. Renal Care Inc
Mansfield, Texas 76063
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from
Mansfield, TX
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McComb Limited Care Facility
McComb, Mississippi 39648
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from
McComb, MS
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Pacific Renal Research Institute
Meridian, Idaho 83642
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from
Meridian, ID
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Nephrology & Hypertension Associates PC
Middlebury, Connecticut 06762
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from
Middlebury, CT
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University of South Alabama Medical Center
Mobile, Alabama 36604
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from
Mobile, AL
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Nephrology-Hypertension Associates of Central New Jersey PA
North Brunswick, New Jersey 80902
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from
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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from
Philadelphia, PA
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Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona 85012
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from
Phoenix, AZ
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Wake Nephrology Associates PA
Raleigh, North Carolina 27609
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from
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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from
Sumter, SC
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Genesis Clinical Research, Inc.
Tampa, Florida 33614
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from
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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from
Winston-Salem, NC
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DaVita Central Orlando Dialysis
Winter Park, Florida 32789
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from
Winter Park, FL
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