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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Trevi Therapeutics
• Treatments: Nalbuphine

Criteria

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.