Skip to main content
OpenTrials
Completed

NCT Number: NCT02174419

Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

The primary objectives of the study are 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 patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Münster, Münster, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject suffering from generalized prurigo nodularis
  • Have demonstrated pruritus intensity during screening
  • Male or female who are at least 18 years old at the time of consent

Exclusion criteria

  • Subject has chronic pruritus resulting from other conditions
  • Subject has a history of substance abuse within the past year
  • Subject has a known drug allergy to opioids
  • Subject is a pregnant or lactating female

Treatment and study plan

nalbuphine HCl ER tablets 90 mg BID

Drug

nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks

Other names: nalbuphine ER

nalbuphine HCl ER tablets 180 mg BID

Drug

nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks

Other names: nalbuphine ER

Placebo tablets BID

Drug

Placebo tablets BID administered for 10 weeks

Other names: sugar pill

Primary outcomes

  1. Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale

    Time frame: Baseline, Week 10

    The number of subjects who reported at least a 30% reduction from baseline to Week 10, expressed as a percentage of subjects in the particular arm/group who were evaluated,

Secondary outcomes

  1. Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale

    Time frame: Baseline, Week 10

Other outcomes

  1. Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale

    Time frame: Baseline, Week 10

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 Prurigo Nodularis Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 25, 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.