Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis
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
2 other identifiers
interventional
62
3 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2015
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
August 21, 2020
CompletedMay 21, 2025
May 1, 2025
1.4 years
June 24, 2014
August 6, 2020
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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,
Baseline, Week 10
Secondary Outcomes (1)
Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale
Baseline, Week 10
Other Outcomes (1)
Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale
Baseline, Week 10
Study Arms (3)
nalbuphine HCl ER 90mg
EXPERIMENTALnalbuphine HCl ER tablets 90 mg BID
nalbuphine HCl ER 180 mg
EXPERIMENTALnalbuphine HCl ER tablets 180 mg BID
Sugar pill
PLACEBO COMPARATORPlacebo tablets BID
Interventions
nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks
nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
Placebo tablets BID administered for 10 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of Münster
Münster, Germany
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-368, Poland
Related Publications (3)
Eudy-Byrne R, Riggs M, Hawi A, Sciascia T, Rohatagi S. A population pharmacokinetic-pharmacodynamic model evaluating efficacy of nalbuphine extended-release in patients with prurigo nodularis. Br J Clin Pharmacol. 2023 Jul;89(7):2088-2101. doi: 10.1111/bcp.15663. Epub 2023 Feb 9.
PMID: 36680419DERIVEDStander 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.
PMID: 34908192DERIVEDWeisshaar 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.
PMID: 34780095DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Sciascia, MD
- Organization
- Trevi Therapeutics
Study Officials
- STUDY DIRECTOR
Chief Development Officer
Trevi Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2014
First Posted
June 25, 2014
Study Start
March 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
May 21, 2025
Results First Posted
August 21, 2020
Record last verified: 2025-05