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

Prurigo Nodularis Clinical Trial

Official title:

An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174432
• Other study ID #: TR03ext
• Secondary ID: 2013-005628-41
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 15, 2015
• Est. completion date: September 3, 2017

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 3, 2017
• Est. primary completion date: September 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject completed participation in the TR03 study

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Neurodermatitis
• Nodularis Prurigo
• Prurigo
• Prurigo Nodularis

Intervention

Drug:
• nalbuphine HCl ER
nalbuphine HCl ER BID for up to 50 weeks

Locations

Country	Name	City	State
Germany	University of Münster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Trevi Therapeutics

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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