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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005627-17 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nalbuphine HCl ER 90mg | Experimental | nalbuphine HCl ER tablets 90 mg BID |
|
| nalbuphine HCl ER 180 mg | Experimental | nalbuphine HCl ER tablets 180 mg BID |
|
| Sugar pill | Placebo Comparator | Placebo tablets BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nalbuphine HCl ER tablets 90 mg BID | Drug | nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale | Baseline, Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale | Baseline, Week 10 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Development Officer | Trevi Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States | ||
| Temple University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36680419 | Derived | 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. | |
| 34908192 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nalbuphine HCl ER 90mg | nalbuphine HCl ER tablets 90 mg BID nalbuphine HCl ER tablets 90 mg BID: nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks |
| FG001 | Nalbuphine HCl ER 180 mg | nalbuphine HCl ER tablets 180 mg BID nalbuphine HCl ER tablets 180 mg BID: nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks |
| FG002 | Sugar Pill | Placebo tablets BID Placebo tablets BID: Placebo tablets BID administered for 10 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nalbuphine HCl ER 90mg | nalbuphine HCl ER tablets 90 mg BID nalbuphine HCl ER tablets 90 mg BID: nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks |
| BG001 | Nalbuphine HCl ER 180 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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, | Posted | Number | percentage of subjects | Baseline, Week 10 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nalbuphine HCl ER 90mg | nalbuphine HCl ER tablets 90 mg BID nalbuphine HCl ER tablets 90 mg BID: nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Sciascia, MD | Trevi Therapeutics | 203-304-2499 | thomas.sciascia@trevitherapeutics.com |
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| ID | Term |
|---|---|
| D011536 | Prurigo |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| nalbuphine HCl ER tablets 180 mg BID | Drug | nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks |
|
|
| Placebo tablets BID | Drug | Placebo tablets BID administered for 10 weeks |
|
|
| 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 |
| 34780095 | Derived | 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. |
nalbuphine HCl ER tablets 180 mg BID
nalbuphine HCl ER tablets 180 mg BID: nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
| BG002 | Sugar Pill | Placebo tablets BID Placebo tablets BID: Placebo tablets BID administered for 10 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Sugar Pill | Placebo tablets BID Placebo tablets BID: Placebo tablets BID administered for 10 weeks |
|
|
| Secondary | Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale | Not Posted | Baseline, Week 10 | Participants |
| Other Pre-specified | Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale | Not Posted | Baseline, Week 10 | Participants |
| 1 |
| 22 |
| 0 |
| 22 |
| EG001 | Nalbuphine HCl ER 180 mg | nalbuphine HCl ER tablets 180 mg BID nalbuphine HCl ER tablets 180 mg BID: nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks | 0 | 18 | 0 | 18 |
| EG002 | Sugar Pill | Placebo tablets BID Placebo tablets BID: Placebo tablets BID administered for 10 weeks | 1 | 22 | 0 | 22 |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications |
|
| Leukocytosis | Blood and lymphatic system disorders |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |