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Phase 1 Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

NCT02373215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-05-22

No results posted yet for this study

Summary

This is a single-center clinical research study with the purpose to evaluate the safety, tolerability, and pharmacokinetics (PK) of nalbuphine HCl ER (extended release) tablets in end-stage renal disease (ESRD) patients receiving hemodialysis (HD) therapy and reporting pruritus.

Conditions

  • Uremic Pruritus

Interventions

DRUG

Nalbuphine HCL ER

Nalbuphine HCL extended release tablet

Sponsors & Collaborators

  • Davita Clinical Research

    collaborator INDUSTRY

  • Trevi Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chief Development Officer · Trevi Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-11-30
Completion
2013-11-30

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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 NCT02373215 on ClinicalTrials.gov