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Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis

NCT02174432 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-05-21

Study results available
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Summary

The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 50 weeks.

Conditions

  • Prurigo Nodularis
  • Nodularis Prurigo
  • Prurigo

Interventions

DRUG

nalbuphine HCl ER

nalbuphine HCl ER BID for up to 50 weeks

Sponsors & Collaborators

  • Trevi Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chief Development Officer · Trevi Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-15
Primary Completion
2017-09-03
Completion
2017-09-03

Countries

  • Germany

Study Locations

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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 NCT02174432 on ClinicalTrials.gov