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

NCT02143648 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 373

Last updated 2025-05-21

Study results available
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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.

Conditions

Interventions

DRUG

nalbuphine HCl ER tablets 60 mg BID

nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks

DRUG

nalbuphine HCl ER tablets 120mg BID

nalbuphine HCl ER tablets 120mg BID administered for 6 weeks

DRUG

Placebo tablets BID

Placebo tablets BID administered for 8 weeks

Sponsors & Collaborators

  • Trevi Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chief Development Officer · Trevi Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02143648 on ClinicalTrials.gov