CompletedPhase 2/3

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

United States167 participantsStarted 2014-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs)

Timeframe: 24 weeks

Trial details

NCT IDNCT02143973

SponsorTrevi Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-01

Results submitted2020-08-05

View on ClinicalTrials.gov More Uremic Pruritus trials