Skip to main content
OpenTrials
Completed

NCT Number: NCT02143648

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uremic Pruritus Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Norbert Barlicki University Hospital No1. of the Medical University of Lodz, Lodz, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nalbuphine HCl ER tablets 60 mg BID

Drug

nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks

Other names: nalbuphine ER

nalbuphine HCl ER tablets 120mg BID

Drug

nalbuphine HCl ER tablets 120mg BID administered for 6 weeks

Other names: nalbuphine ER

Placebo tablets BID

Drug

Placebo tablets BID administered for 8 weeks

Other names: sugar pill

Primary outcomes

  1. Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Trevi Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 21, 2014
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.