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



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:8/30/2018
Start Date:June 2014
End Date:July 2015

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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

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.


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.
We found this trial at
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Azusa, California 91702
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Pembroke Pines, Florida 33028
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Albany, GA
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Albuquerque, New Mexico 87109
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Bakersfield, California 93308
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Bakersfield, California 93309
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Bethlehem, Pennsylvania 18017
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Birmingham, Alabama 35211
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Chattanooga, Tennessee 37408
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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College Point, New York 11356
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Durham, North Carolina 27704
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Evergreen Park, Illinois 60805
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Fort Worth, Texas 76105
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Fort Worth, Texas 76105
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Hampton, South Carolina 29924
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Kansas City, Missouri 64131
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Lodz,
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Los Angeles, California 90022
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Macon, Georgia 31217
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Mansfield, Texas 76063
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McComb, Mississippi 39648
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Meridian, Idaho 83642
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Middlebury, Connecticut 06762
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Mobile, AL
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North Brunswick, NJ
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Orangeburg, South Carolina 29118
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Philadelphia, Pennsylvania 19118
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Philadelphia, Pennsylvania 19140
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Phoenix, AZ
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Pine Bluff, Arkansas 76103
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Raleigh, North Carolina 27609
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Shorewood, Wisconsin 53211
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Springfield, Massachusetts 01107
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Stamford, Connecticut 06902
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Sumter, South Carolina 29150
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Tampa, Florida 33614
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Tonawanda, New York 14150
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Whittier, California 90606
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Winston-Salem, North Carolina 27103
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Winter Park, Florida 32789
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