Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus
NCT ID: NCT02143973
Last Updated: 2025-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
167 participants
INTERVENTIONAL
2014-09-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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nalbuphine HCl ER
nalbuphine HCl ER titrated from a dose of 30 mg QD to 120 BID for up to 3 weeks based on tolerability and efficacy, then maintained for an additional 21 weeks. Total duration of 24 weeks.
nalbuphine HCl ER
nalbuphine HCl ER
Interventions
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nalbuphine HCl ER
nalbuphine HCl ER
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is currently receiving in-center hemodialysis at the time of consent
Exclusion Criteria
* 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
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 Center
Bakersfield, California, United States
Central Nephrology Medical Group
Bakersfield, California, United States
Mark Lee MD, Inc
Whittier, California, United States
Nephrology and Hypertension Associates PC
Middlebury, Connecticut, United States
Pines Clinical Research
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
Nephrology Center DBA Paragon Health
Kalamazoo, Michigan, 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
Astoria, 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
Carolina Diabetes and Kidney Center
Sumter, South Carolina, United States
SouthEast 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
Countries
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Other Identifiers
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2013-005626-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TR02ext
Identifier Type: -
Identifier Source: org_study_id
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