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

Trevi Therapeutics

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nodularis Prurigo; Prurigo Nodularis; Prurigo

Treatments: Drug: nalbuphine HCl ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT02174432

2013-005628-41 (EudraCT Number)

TR03ext

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

nalbuphine HCl ER

Experimental group

Description:

nalbuphine HCl ER

Treatment:

Drug: nalbuphine HCl ER