Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis

NCT02174432 | Completed Phase 2 Results

• 2 other identifiers: TR03ext2013-005628-41
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 50 weeks.

Conditions

Prurigo Nodularis; Nodularis Prurigo; Prurigo

Keywords

Itch; Chronic Itch; Nalbupine

Outcome Measures

Primary Outcomes (1)

• Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs)

  Incidence of adverse events is calculated based on events observed on or after the date of first dose, where incidence is defined as the number of subjects who reported one or more events of a particular adverse event divided by the number of subjects who received at least one dose of investigational product. Overall incidence is the proportion of subjects who had one or more adverse events of any type and nature pertains to the incidence of individual events coded by MedDRA nomenclature. An additional consideration was to evaluate incidence of adverse events by dose achieved but this was not done as subjects achieved a maximum dose during the study that varied and, per protocol, dosing could be modified per the investigator, during the course of this extension to TR03. In addition, TR03EXT involved a dose titration whereas events could have been reported well before a subject achieved some partciular dose level. Consequently, such a presentation would have been impossible to discern.

  50 weeks

Study Arms (1)

nalbuphine HCl ER

EXPERIMENTAL

nalbuphine HCl ER

Drug: nalbuphine HCl ER

Interventions

nalbuphine HCl ER DRUG

nalbuphine HCl ER BID for up to 50 weeks

Also known as: nalbuphine

nalbuphine HCl ER

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject completed participation in the TR03 study

You may not qualify if:

• Medical condition or other factors that in the opinion of the Investigator may interfere with the conduct of the study.
• Subject is a pregnant or lactating female

Sponsors & Collaborators

• Trevi Therapeutics: lead

Study Sites (1)

University of Münster

Münster, Germany

Location

MeSH Terms

Conditions

Prurigo; Pruritus

Interventions

Nalbuphine

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Thomas Sciascia, MD
• Organization: Trevi Therapeutics

thomas.sciascia@trevitherapeutics.com

203-304-2499

Study Officials

• Chief Development Officer

  Trevi Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 25, 2014
• Study Start: August 15, 2015
• Primary Completion: September 3, 2017
• Study Completion: September 3, 2017
• Last Updated: May 21, 2025
• Results First Posted: October 23, 2020

Record last verified: 2025-05

Locations

DE (1)