Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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 24 weeks.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trevi Therapeutics
• Treatments: Nalbuphine

Criteria

Inclusion Criteria:

• Subject completed participation in the TR02 study

• Subject is currently receiving in-center hemodialysis at the time of consent

Exclusion Criteria:

• Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study

• Subject 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