Prurigo NodularisPhase 2/3NCT02174419
Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis
A Phase 2/3 study testing nalbuphine HCl ER tablets 90 mg BID and nalbuphine HCl ER tablets 180 mg BID in people with Prurigo Nodularis and Nodularis Prurigo, run by Trevi Therapeutics at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prurigo Nodularis, Nodularis Prurigo, Prurigo
- What is being tested?
- nalbuphine HCl ER tablets 90 mg BID and nalbuphine HCl ER tablets 180 mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Mar 2015to Aug 2016
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Case Western Reserve University
Cleveland, Ohio, 44106
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Poland1 site
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-368
About this study
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
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
- Being tested
- nalbuphine HCl ER tablets 90 mg BID, nalbuphine HCl ER tablets 180 mg BID, Placebo tablets BID
- Keywords
- Itch, Chronic Itch, nalbuphine
- Medical subject headings
- Prurigo, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nalbuphine HCl ER tablets 90 mg BIDDrug
Also called nalbuphine ER
nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks
nalbuphine HCl ER tablets 180 mg BIDDrug
Also called nalbuphine ER
nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
Placebo tablets BIDDrug
Also called sugar pill
Placebo tablets BID administered for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| nalbuphine HCl ER 90mg | Experimental | nalbuphine HCl ER tablets 90 mg BID Receives: Drug: nalbuphine HCl ER tablets 90 mg BID |
| nalbuphine HCl ER 180 mg | Experimental | nalbuphine HCl ER tablets 180 mg BID Receives: Drug: nalbuphine HCl ER tablets 180 mg BID |
| Sugar pill | Placebo comparator | Placebo tablets BID Receives: Drug: Placebo tablets BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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
Measured: Baseline, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startMar 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prurigo NodularisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trevi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Development Officer, Study director, Trevi Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174419
- Sponsor's protocol ID
- TR03
- Other IDs
- 2013-005627-17
- Status last verified
- May 2025
- First submitted
- 24 Jun 2014
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 36680419Stander 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.
PubMed 34908192Weisshaar 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.
PubMed 34780095
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02174419
- Acronym / sponsor ID
- TR03
- Conditions
- Prurigo Nodularis, Nodularis Prurigo, Prurigo, Pruritus
- Keywords
- Itch, Chronic Itch, nalbuphine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Trevi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Posted 21 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nalbuphine HCl ER 90mg | Experimental | Drug: nalbuphine HCl ER tablets 90 mg BIDnalbuphine HCl ER tablets 90 mg BID |
| nalbuphine HCl ER 180 mg | Experimental | Drug: nalbuphine HCl ER tablets 180 mg BIDnalbuphine HCl ER tablets 180 mg BID |
| Sugar pill | Placebo comparator | Drug: Placebo tablets BIDPlacebo tablets BID |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nalbuphine HCl ER tablets 90 mg BIDAlso: nalbuphine ERnalbuphine HCl ER tablets 90 mg BID administered for 8 weeks | Drug | nalbuphine HCl ER 90mg |
| nalbuphine HCl ER tablets 180 mg BIDAlso: nalbuphine ERnalbuphine HCl ER tablets 180 mg BID administered for 8 weeks | Drug | nalbuphine HCl ER 180 mg |
| Placebo tablets BIDAlso: sugar pillPlacebo tablets BID administered for 10 weeks | Drug | Sugar pill |
Primary outcome
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,
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36680419Eudy-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.
- Derived from this study: PubMed 34908192Stander 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.
- Derived from this study: PubMed 34780095Weisshaar 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.
Related trials for Prurigo Nodularis
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Prurigo Nodularis.
Prurigo Nodularis (PN)
RecruitingPhase 3
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
Prurigo Nodularis
RecruitingPhase 2
Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
Prurigo Nodularis (PN)
RecruitingObservational study
Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults
Prurigo Nodularis
Not yet recruitingPhase 2
Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients
Prurigo Nodularis (PN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Development Officer study director
Trevi Therapeutics
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing nalbuphine HCl ER tablets 90 mg BID and nalbuphine HCl ER tablets 180 mg BID in people with Prurigo Nodularis and Nodularis Prurigo, run by Trevi Therapeutics at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale (time frame: Baseline, Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02174419, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.