albuphine HCl ER Tablets in Hemodialysis Patients with Uremic Pruritis

Conditions: remic Pruritis in Hemodialysis Patients
MedDRA version: 18.1Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2013-005626-29-PL

Lead Sponsor: Trevi Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 360

Inclusion Criteria

• Subject completed participation in the TR02 study
• Subject is currently receiving in-center hemodialysis at the time of consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 98
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

• Subject receiving or is anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study.
• Subject has received opiates on a daily basis during the 1 week prior to Screening
• Other than the TR02 Study Drug, subject received any investigational drug within 4 weeks prior to Screening.
• Subject is a pregnant or lactating female.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the safety and tolerability of nalbuphine HCl ER tablets during a drug treatment period of up to 24 weeks.;Secondary Objective: The secondary objective of the study is to evaluate the safety of nalbuphine by achieved dose at the end of Treatment Period Week 3.;Primary end point(s): A description of the overall incidence and nature of Treatment-Emergent AEs (TEAES);Timepoint(s) of evaluation of this end point: 24 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): A description of the incidence and nature of TEAEs during Treatment by achieved dose, Weeks 4 - 24.;Timepoint(s) of evaluation of this end point: Week 24