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Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

Primary Purpose

Prurigo Nodularis, Nodularis Prurigo, Prurigo

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
nalbuphine HCl ER tablets 90 mg BID
nalbuphine HCl ER tablets 180 mg BID
Placebo tablets BID
Sponsored by
Trevi Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prurigo Nodularis focused on measuring Itch, Chronic Itch, nalbuphine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Case Western Reserve University
  • Temple University Hospital
  • University of Münster
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

nalbuphine HCl ER 90mg

nalbuphine HCl ER 180 mg

Sugar pill

Arm Description

nalbuphine HCl ER tablets 90 mg BID

nalbuphine HCl ER tablets 180 mg BID

Placebo tablets BID

Outcomes

Primary Outcome Measures

Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale
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,

Secondary Outcome Measures

Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale

Full Information

First Posted
June 24, 2014
Last Updated
October 5, 2020
Sponsor
Trevi Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02174419
Brief Title
Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trevi Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prurigo Nodularis, Nodularis Prurigo, Prurigo, Pruritus
Keywords
Itch, Chronic Itch, nalbuphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nalbuphine HCl ER 90mg
Arm Type
Experimental
Arm Description
nalbuphine HCl ER tablets 90 mg BID
Arm Title
nalbuphine HCl ER 180 mg
Arm Type
Experimental
Arm Description
nalbuphine HCl ER tablets 180 mg BID
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo tablets BID
Intervention Type
Drug
Intervention Name(s)
nalbuphine HCl ER tablets 90 mg BID
Other Intervention Name(s)
nalbuphine ER
Intervention Description
nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks
Intervention Type
Drug
Intervention Name(s)
nalbuphine HCl ER tablets 180 mg BID
Other Intervention Name(s)
nalbuphine ER
Intervention Description
nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo tablets BID
Other Intervention Name(s)
sugar pill
Intervention Description
Placebo tablets BID administered for 10 weeks
Primary Outcome Measure Information:
Title
Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale
Description
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,
Time Frame
Baseline, Week 10
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale
Time Frame
Baseline, Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Sciascia
Organizational Affiliation
Trevi Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Münster
City
Münster
Country
Germany
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-368
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34908192
Citation
Stander S, Zeidler C, Pereira M, Szepietowski JC, McLeod L, Qin S, Williams N, Sciascia T, Augustin M. Worst itch numerical rating scale for prurigo nodularis: a psychometric evaluation. J Eur Acad Dermatol Venereol. 2022 Apr;36(4):573-581. doi: 10.1111/jdv.17870. Epub 2022 Feb 14.
Results Reference
derived
PubMed Identifier
34780095
Citation
Weisshaar E, Szepietowski JC, Bernhard JD, Hait H, Legat FJ, Nattkemper L, Reich A, Sadoghi B, Sciascia TR, Zeidler C, Yosipovitch G, Stander S. Efficacy and safety of oral nalbuphine extended release in prurigo nodularis: results of a phase 2 randomized controlled trial with an open-label extension phase. J Eur Acad Dermatol Venereol. 2022 Mar;36(3):453-461. doi: 10.1111/jdv.17816. Epub 2021 Dec 1.
Results Reference
derived

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Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

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