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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02143648
Recruitment Status : Completed
First Posted : May 21, 2014
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Trevi Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Uremic Pruritus Pruritus Drug: nalbuphine HCl ER tablets 60 mg BID Drug: nalbuphine HCl ER tablets 120mg BID Drug: Placebo tablets BID Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 373 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015


Arm Intervention/treatment
Experimental: nalbuphine HCl ER 60mg
nalbuphine HCl ER tablets 60 mg BID
Drug: nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
Other Name: nalbuphine ER

Experimental: nalbuphine HCl ER 120mg
nalbuphine HCl ER tablets 120 mg BID
Drug: nalbuphine HCl ER tablets 120mg BID
nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
Other Name: nalbuphine ER

Placebo Comparator: Sugar pill
Placebo tablets BID
Drug: Placebo tablets BID
Placebo tablets BID administered for 8 weeks
Other Name: sugar pill




Primary Outcome Measures :
  1. Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale [ Time Frame: 8 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143648


Locations
Show Show 47 study locations
Sponsors and Collaborators
Trevi Therapeutics
Investigators
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Study Director: Thomas Sciascia, MD Trevi Therapeutics
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Trevi Therapeutics
ClinicalTrials.gov Identifier: NCT02143648    
Other Study ID Numbers: TR02
2013-005625-22 ( EudraCT Number )
First Posted: May 21, 2014    Key Record Dates
Results First Posted: September 7, 2020
Last Update Posted: September 7, 2020
Last Verified: August 2020
Keywords provided by Trevi Therapeutics:
uremic
pruritus
itch
chronic itch
nalbuphine
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents