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Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

NCT02174419 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-05-21

Study results available
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Summary

The primary objectives of the study are 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 patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.

Conditions

  • Prurigo Nodularis
  • Nodularis Prurigo
  • Prurigo
  • Pruritus

Interventions

DRUG

nalbuphine HCl ER tablets 90 mg BID

nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks

DRUG

nalbuphine HCl ER tablets 180 mg BID

nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks

DRUG

Placebo tablets BID

Placebo tablets BID administered for 10 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
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States
  • Germany
  • Poland

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 NCT02174419 on ClinicalTrials.gov