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

Uremic Pruritus research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Uremic Pruritus

Pruritus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:nalbuphine HCl ER 60mg BIDnalbuphine HCl ER 60mg BID for up to 24 weeks

Drug:nalbuphine HCl ER 90mg BIDnalbuphine HCl ER 90mg BID for up to 24 weeks

Drug:nalbuphine HCl ER 120mg BIDnalbuphine HCl ER 120mg BID for up to 24 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

nalbuphine HCl ER 60mgnalbuphine HCl ER 60mg BID

nalbuphine HCl ER 90mgnalbuphine HCl ER 90mg BID

nalbuphine HCl ER 120mgnalbuphine HCl ER 120mg BID

Study Status

Completed

Start Date: September 2014

Completed Date: January 2016

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Overall incidence frequency and nature of Treatment Emergent Adverse Events (TEAEs)

Secondary Outcome: Incidence, frequency and nature of Treatment Emergent Adverse Events (TEAEs) during Treatment by achieved dose

Study sponsors, principal investigator, and references

Principal Investigator: Thomas Sciascia, MD

Lead Sponsor: Trevi Therapeutics

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02143973

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