Uremic Pruritus | Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
Uremic Pruritus research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:nalbuphine HCl ER tablets 60 mg BIDnalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
Drug:nalbuphine HCl ER tablets 120mg BIDnalbuphine HCl ER tablets 120mg BID administered for 6 weeks
Drug:Placebo tablets BIDPlacebo tablets BID administered for 8 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
nalbuphine HCl ER 60mgnalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER 120mgnalbuphine HCl ER tablets 120 mg BID
Sugar pillPlacebo tablets BID
Start Date: June 2014
Completed Date: July 2015
Phase: Phase 2/Phase 3
Primary Outcome: Change from Baseline to the Evaluation Period (weeks 7 and 8) in itch on the 0-10 Itch Numerical Rating Scale
Secondary Outcome: Change from Baseline scores to the Evaluation Period (weeks 7 and 8) in the total Skindex-10 score
Study sponsors, principal investigator, and references
Principal Investigator: Thomas Sciascia, MD
Lead Sponsor: Trevi Therapeutics