Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
NCT ID: NCT02143648
Last Updated: 2025-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
373 participants
INTERVENTIONAL
2014-06-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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nalbuphine HCl ER 60mg
nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
nalbuphine HCl ER 120mg
nalbuphine HCl ER tablets 120 mg BID
nalbuphine HCl ER tablets 120mg BID
nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
Sugar pill
Placebo tablets BID
Placebo tablets BID
Placebo tablets BID administered for 8 weeks
Interventions
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nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
nalbuphine HCl ER tablets 120mg BID
nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
Placebo tablets BID
Placebo tablets BID administered for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject self-categorized themselves on the Patient Assessed Disease Severity Scale during Screening
* Subject meets standard of care hemodialysis efficiency guidelines during the three months prior to completing Screening
* Have demonstrated pruritus intensity on the Itch NRS during screening
* Male or female who are at least 18 years old at the time of Screening
Exclusion Criteria
* Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study.
* Subject has pruritus that is believed to be caused by a condition unrelated to end-stage renal disease
* Has had a history of substance abuse within 6 months prior to completing Screening
* Subject has a known drug allergy to opioids
* Subject is a pregnant or lactating female.
18 Years
ALL
No
Sponsors
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Trevi Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Development Officer
Role: STUDY_DIRECTOR
Trevi Therapeutics
Locations
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Nephrology Associates PC
Birmingham, Alabama, United States
University South Alabama Medical Center
Mobile, Alabama, United States
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, United States
U.S. Renal Care Inc
Pine Bluff, Arkansas, United States
North America Research Institute
Azusa, California, United States
Pegasus Dialysis, LLC
Bakersfield, California, United States
Central Nephrology Medical Group
Bakersfield, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
Mark Lee MD, Inc
Whittier, California, United States
Nephrology and Hypertension Associates PC
Middlebury, Connecticut, United States
DaVita Inc Clinical Research Unit
Stamford, Connecticut, United States
Nephrology Center DBA Paragon Health
Miami, Florida, United States
Pines Clinical Research Inc
Pembroke Pines, Florida, United States
Genesis Clinical Research
Tampa, Florida, United States
DaVita Central Orlando Dialysis
Winter Park, Florida, United States
Southwest Georgia Nephrology Clinic PC
Albany, Georgia, United States
Renal Physicians of Georgia
Macon, Georgia, United States
Pacific Renal Research Institute
Meridian, Idaho, United States
Fresenius Medical Care of Evergreen Park
Evergreen Park, Illinois, United States
Western New England Renal and Transplant Association
Springfield, Massachusetts, United States
McComb Limited Care Facility
McComb, Mississippi, United States
Kidney Associates of Kansas City PC
Kansas City, Missouri, United States
Nephrology-Hypertension Associates of Central New Jersey PA
North Brunswick, New Jersey, United States
Renal Medicine Associates
Albuquerque, New Mexico, United States
Newtown Dialysis Center, Inc
College Point, New York, United States
DaVita Northtown's Dialysis Center
Tonawanda, New York, United States
Durham Nephrology Associates
Durham, North Carolina, United States
Wake Nephrology Associates PA
Raleigh, North Carolina, United States
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, United States
University Of Cincinnati
Cincinnati, Ohio, United States
Nephrology Research Consortium
Bethlehem, Pennsylvania, United States
Delaware Valley Nephrology
Philadelphia, Pennsylvania, United States
Dialysis Clinic Inc.
Philadelphia, Pennsylvania, United States
South Carolina Nephrology and Hypertension
Hampton, South Carolina, United States
South Carolina Nephrology and Hypertension
Orangeburg, South Carolina, United States
Carolina Diabetes and Kidney Center
Sumter, South Carolina, United States
Southwest Renal Research Institute
Chattanooga, Tennessee, United States
U.S. Renal Care Inc
Fort Worth, Texas, United States
U.S Renal Care Inc.
Fort Worth, Texas, United States
U.S. Renal Care Inc.
Mansfield, Texas, United States
Fresenius Medical Care Shorewood
Shorewood, Wisconsin, United States
Norbert Barlicki University Hospital No1. of the Medical University of Lodz
Lodz, , Poland
International Healthcare Systems S.A IHS Craiova Dialysis Center
Craiova, Dolj, Romania
International Healthcare Systems S.A IHS Fundeni Dialysis Center
Bucharest, , Romania
S.C Gral Medical S.R.L
Bucharest, , Romania
S.C Diaverum Romania S.R.I, Industriilor Diaverum Dialysis Center
Bucharest, , Romania
SC Diaverum Romania SRL, Splai Dialysis Center
Bucharest, , Romania
Countries
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References
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Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Other Identifiers
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2013-005625-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TR02
Identifier Type: -
Identifier Source: org_study_id
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