CompletedPhase 2/3

Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

United States, Poland, Romania373 participantsStarted 2014-06

Plain-language summary

The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population.

Who can participate

Age range

18 Years

Sex

ALL

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 has been receiving in-center hemodialysis for ≥ 3 months and are currently on a schedule of 3 times a week. * Subject self-categorized themselves on the Patient Assessed Disease Severity Scale during Screening * Subject meets standard of care hemodialysis efficiency guidelines during the three months prior to completing Screening * Have demonstrated pruritus intensity on the Itch NRS during screening * Male or female who are at least 18 years old at the time of Screening Exclusion Criteria: * Subject had a significant alteration in dialysis regimen during the Screening Period * Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study. * Subject has pruritus that is believed to be caused by a condition unrelated to end-stage renal disease * Has had a history of substance abuse within 6 months prior to completing Screening * Subject has a known drug allergy to opioids * Subject is a pregnant or lactating female.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale

Timeframe: 8 weeks

Trial details

NCT IDNCT02143648

SponsorTrevi Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-07

Results submitted2020-08-04

View on ClinicalTrials.gov More Uremic Pruritus trials