Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

Pruritus Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm 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: NCT02143648
• Other study ID #: TR02
• Secondary ID: 2013-005625-22
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2020
• Source: Trevi Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has been receiving in-center hemodialysis for = 3 months and are currently on a schedule of 3 times a week.

• 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 had a significant alteration in dialysis regimen during the Screening Period

• 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.

Related Conditions & MeSH terms

• Pruritus
• Uremic Pruritus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Poland	Norbert Barlicki University Hospital No1. of the Medical University of Lodz	Lodz
Romania	International Healthcare Systems S.A IHS Fundeni Dialysis Center	Bucharest
Romania	S.C Diaverum Romania S.R.I, Industriilor Diaverum Dialysis Center	Bucharest
Romania	S.C Gral Medical S.R.L	Bucharest
Romania	SC Diaverum Romania SRL, Splai Dialysis Center	Bucharest
Romania	International Healthcare Systems S.A IHS Craiova Dialysis Center	Craiova	Dolj
United States	Southwest Georgia Nephrology Clinic PC	Albany	Georgia
United States	Renal Medicine Associates	Albuquerque	New Mexico
United States	North America Research Institute	Azusa	California
United States	Central Nephrology Medical Group	Bakersfield	California
United States	Pegasus Dialysis, LLC	Bakersfield	California
United States	Nephrology Research Consortium	Bethlehem	Pennsylvania
United States	Nephrology Associates PC	Birmingham	Alabama
United States	Southwest Renal Research Institute	Chattanooga	Tennessee
United States	University Of Cincinnati	Cincinnati	Ohio
United States	Newtown Dialysis Center, Inc	College Point	New York
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	South Carolina Nephrology and Hypertension	Hampton	South Carolina
United States	Kidney Associates of Kansas City PC	Kansas City	Missouri
United States	Academic Medical Research Institute	Los Angeles	California
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 Center DBA Paragon Health	Miami	Florida
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	South Carolina Nephrology and Hypertension	Orangeburg	South Carolina
United States	Pines Clinical Research Inc	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	Fresenius Medical Care Shorewood	Shorewood	Wisconsin
United States	Western New England Renal and Transplant Association	Springfield	Massachusetts
United States	DaVita Inc Clinical Research Unit	Stamford	Connecticut
United States	Carolina Diabetes and Kidney Center	Sumter	South Carolina
United States	Genesis Clinical Research	Tampa	Florida
United States	DaVita Northtown's Dialysis Center	Tonawanda	New York
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

Countries where clinical trial is conducted

United States,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale	The evaluation period was defined as the average itch score over weeks 7 and 8 following initiation of treatment. A negative change form baseline (Evaluation Period - Baseline) signified inmprovement.	8 weeks