Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

May 19, 2025 updated by: Trevi Therapeutics

A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Münster, Germany
        • University of Munster
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 50-368
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject suffering from generalized prurigo nodularis
  • Have demonstrated pruritus intensity during screening
  • Male or female who are at least 18 years old at the time of consent

Exclusion Criteria:

  • Subject has chronic pruritus resulting from other conditions
  • Subject has a history of substance abuse within the past year
  • Subject has a known drug allergy to opioids
  • Subject is a pregnant or lactating female

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nalbuphine HCl ER 90mg
nalbuphine HCl ER tablets 90 mg BID
Drug: nalbuphine HCl ER tablets 90 mg BID
nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks
Other Names:
  • nalbuphine ER
Experimental: nalbuphine HCl ER 180 mg
nalbuphine HCl ER tablets 180 mg BID
Drug: nalbuphine HCl ER tablets 180 mg BID
nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
Other Names:
  • nalbuphine ER
Placebo Comparator: Sugar pill
Placebo tablets BID
Drug: Placebo tablets BID
Placebo tablets BID administered for 10 weeks
Other Names:
  • sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale
Time Frame: Baseline, Week 10
The number of subjects who reported at least a 30% reduction from baseline to Week 10, expressed as a percentage of subjects in the particular arm/group who were evaluated,
Baseline, Week 10

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale
Time Frame: Baseline, Week 10
Baseline, Week 10

Other Outcome Measures

Outcome Measure
Time Frame
Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale
Time Frame: Baseline, Week 10
Baseline, Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trevi Therapeutics

Investigators

  • Study Director: Chief Development Officer, Trevi Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimated)

June 25, 2014

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR03
  • 2013-005627-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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