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

Phase 2

Completed

• Conditions: Prurigo Nodularis; Nodularis Prurigo; Prurigo
• Interventions: Drug: nalbuphine HCl ER

• Registration Number: NCT02174432
• Lead Sponsor: Trevi Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Study Start: 2015-08-15
• Primary Completion: 2017-09-03
• Study Completion: 2017-09-03
• Disposition First Submitted: 2018-08-22
• Disposition First Submitted QC: 2018-08-22
• Disposition First Posted: 2018-08-28
• Results First Submitted: 2020-08-06
• Status Verified: 2020-09
• Results First Submitted QC: 2020-10-05
• Last Update Submitted: 2020-10-05
• Results First Posted: 2020-10-23
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Subject completed participation in the TR03 study

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nalbuphine HCl ER	nalbuphine HCl ER	nalbuphine HCl ER

Primary Outcome Measures

Name	Time	Method
Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs)	50 weeks	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.

Trial Locations

Locations (1)

University of Münster; 🇩🇪 Münster, Germany