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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
373
nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
Placebo tablets BID administered for 8 weeks
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.
Time frame: 8 weeks
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