Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prurigo Nodularis, Nodularis Prurigo, Prurigo, Pruritus

Intervention / Treatment
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* Drug: nalbuphine HCl ER tablets 90 mg BID
* Drug: nalbuphine HCl ER tablets 180 mg BID
* Drug: Placebo tablets BID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nalbuphine HCl ER 90mg<br>nalbuphine HCl ER tablets 90 mg BID | Drug: nalbuphine HCl ER tablets 90 mg BID<br>* nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks<br>* Other names: nalbuphine ER;|
| Experimental: nalbuphine HCl ER 180 mg<br>nalbuphine HCl ER tablets 180 mg BID | Drug: nalbuphine HCl ER tablets 180 mg BID<br>* nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks<br>* Other names: nalbuphine ER;|
| Placebo Comparator: Sugar pill<br>Placebo tablets BID | Drug: Placebo tablets BID<br>* Placebo tablets BID administered for 10 weeks<br>* Other names: sugar pill;|

What is the study measuring?
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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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Itch, Chronic Itch, nalbuphine