Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

Study Overview
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Brief Summary
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The primary objectives of the study 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 hemodialysis patients with moderate to severe uremic pruritus 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 Hemodialysis Patients With Uremic Pruritus

Conditions
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Pruritus, Uremic Pruritus

Intervention / Treatment
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* Drug: nalbuphine HCl ER tablets 60 mg BID
* Drug: nalbuphine HCl ER tablets 120mg BID
* Drug: Placebo tablets BID


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has been receiving in-center hemodialysis for ≥ 3 months and are currently on a schedule of 3 times a week. Subject self-categorized themselves on the Patient Assessed Disease Severity Scale during Screening Subject meets standard of care hemodialysis efficiency guidelines during the three months prior to completing Screening Have demonstrated pruritus intensity on the Itch NRS during screening Male or female who are at least 18 years old at the time of Screening Exclusion Criteria: Subject had a significant alteration in dialysis regimen during the Screening Period Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study. Subject has pruritus that is believed to be caused by a condition unrelated to end-stage renal disease Has had a history of substance abuse within 6 months prior to completing Screening 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

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 60mg<br>nalbuphine HCl ER tablets 60 mg BID | Drug: nalbuphine HCl ER tablets 60 mg BID<br>* nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks<br>* Other names: nalbuphine ER;|
| Experimental: nalbuphine HCl ER 120mg<br>nalbuphine HCl ER tablets 120 mg BID | Drug: nalbuphine HCl ER tablets 120mg BID<br>* nalbuphine HCl ER tablets 120mg BID administered for 6 weeks<br>* Other names: nalbuphine ER;|
| Placebo Comparator: Sugar pill<br>Placebo tablets BID | Drug: Placebo tablets BID<br>* Placebo tablets BID administered for 8 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 Period in Itch on the 0-10 Itch Numerical Rating Scale | The evaluation period was defined as the average itch score over weeks 7 and 8 following initiation of treatment. A negative change form baseline (Evaluation Period - Baseline) signified inmprovement. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uremic, pruritus, itch, chronic itch, nalbuphine