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NCT02143973 Clinical Trial

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

Pruritus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02143973
Other study ID # TR02ext
Secondary ID 2013-005626-29
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date September 2014
Est. completion date January 2016

Study information
Verified date August 2020
Source Trevi Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 167
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• nalbuphine HCl ER
nalbuphine HCl ER

Locations
Country Name City State
United States Southwest Georgia Nephrology Clinic PC Albany Georgia
United States Renal Medicine Associates Albuquerque New Mexico
United States Newtown Dialysis Center Inc Astoria New York
United States North America Research Institute Azusa California
United States Central Nephrology Medical Group Bakersfield California
United States Pegasus Dialysis Center Bakersfield California
United States Nephrology Research Consortium Bethlehem Pennsylvania
United States Nephrology Associates PC Birmingham Alabama
United States SouthEast Renal Research Institute Chattanooga Tennessee
United States University of Cincinnati Cincinnati Ohio
United States Durham Nephrology Associates Durham North Carolina
United States Fresenius Medical Care of Evergreen Park Evergreen Park Illinois
United States U.S. Renal Care Inc. Fort Worth Texas
United States U.S. Renal Care, Inc. Fort Worth Texas
United States Nephrology Center DBA Paragon Health Kalamazoo Michigan
United States Kidney Associates of Kansas City PC Kansas City Missouri
United States Renal Physicians of Georgia Macon Georgia
United States U.S. Renal Care Inc Mansfield Texas
United States McComb Limited Care Facility McComb Mississippi
United States Pacific Renal Research Institute Meridian Idaho
United States Nephrology and Hypertension Associates PC Middlebury Connecticut
United States University South Alabama Medical Center Mobile Alabama
United States Nephrology-Hypertension Associates of Central New Jersey PA North Brunswick New Jersey
United States Pines Clinical Research Pembroke Pines Florida
United States Delaware Valley Nephrology Philadelphia Pennsylvania
United States Dialysis Clinic, Inc. Philadelphia Pennsylvania
United States Arizona Kidney Disease and Hypertension Center Phoenix Arizona
United States U.S. Renal Care Inc. Pine Bluff Arkansas
United States Wake Nephrology Associates PA Raleigh North Carolina
United States Western New England Renal and Transplant Association Springfield Massachusetts
United States Carolina Diabetes and Kidney Center Sumter South Carolina
United States Genesis Clinical Research Tampa Florida
United States Mark Lee MD, Inc Whittier California
United States Brookview Hills Research Associates LLC Winston-Salem North Carolina
United States DaVita Central Orlando Dialysis Winter Park Florida

Sponsors (1)
Lead Sponsor Collaborator
Trevi Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence) 24 weeks
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