Back to resultsOpen Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis
Primary Purpose
Prurigo Nodularis, Nodularis Prurigo, Prurigo
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
nalbuphine HCl ER
Sponsored by
About this trial
This is an interventional treatment trial for Prurigo Nodularis focused on measuring Itch, Chronic Itch, Nalbupine
Eligibility Criteria
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
Sites / Locations
- University of Münster
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nalbuphine HCl ER
Arm Description
nalbuphine HCl ER
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02174432
Brief Title
Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis
Official Title
An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2015 (Actual)
Primary Completion Date
September 3, 2017 (Actual)
Study Completion Date
September 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trevi Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prurigo Nodularis, Nodularis Prurigo, Prurigo
Keywords
Itch, Chronic Itch, Nalbupine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nalbuphine HCl ER
Arm Type
Experimental
Arm Description
nalbuphine HCl ER
Intervention Type
Drug
Intervention Name(s)
nalbuphine HCl ER
Other Intervention Name(s)
nalbuphine
Intervention Description
nalbuphine HCl ER BID for up to 50 weeks
Primary Outcome Measure Information:
Title
Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
50 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Sciascia, MD
Organizational Affiliation
Trevi Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Münster
City
Münster
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis
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