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Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

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: NCT02174419
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prurigo Nodularis Nodularis Prurigo Prurigo Pruritus Drug: nalbuphine HCl ER tablets 90 mg BID Drug: nalbuphine HCl ER tablets 180 mg BID Drug: Placebo tablets BID Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 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 Prurigo Nodularis Patients
Study Start Date : March 2015
Primary Completion Date : August 2016
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: nalbuphine HCl ER 90mg
nalbuphine HCl ER tablets 90 mg BID
Drug: nalbuphine HCl ER tablets 90 mg BID
nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks
Other Name: nalbuphine ER
Experimental: nalbuphine HCl ER 180 mg
nalbuphine HCl ER tablets 180 mg BID
Drug: nalbuphine HCl ER tablets 180 mg BID
nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
Other Name: nalbuphine ER
Placebo Comparator: Sugar pill
Placebo tablets BID
Drug: Placebo tablets BID
Placebo tablets BID administered for 10 weeks
Other Name: sugar pill


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline to the Evaluation Visit (Week 10) in itch on the 0-10 Numerical Rating Scale [ Time Frame: Baseline, Week 10 ]

Secondary Outcome Measures :
  1. Change from Baseline to the Evaluation Visit (Week 10) in the mean itch on the 0-10 Numerical Rating Scale [ Time Frame: Baseline, Week 10 ]

Other Outcome Measures:
  1. Change from Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale [ Time Frame: Baseline, Week 10 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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): NCT02174419


Locations
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Germany
University of Münster
Münster, Germany
Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, Dolnoslaskie, Poland, 50-368
Sponsors and Collaborators
Trevi Therapeutics
Investigators
Study Director: Thomas Sciascia, MD Trevi Therapeutics
More Information

Responsible Party: Trevi Therapeutics
ClinicalTrials.gov Identifier: NCT02174419     History of Changes
Other Study ID Numbers: TR03
2013-005627-17 ( EudraCT Number )
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: May 2017

Keywords provided by Trevi Therapeutics:
Itch
Chronic Itch
nalbuphine

Additional relevant MeSH terms:
Nalbuphine
Pruritus
Prurigo
Neurodermatitis
Skin Diseases
Skin Manifestations
Signs and Symptoms
Dermatitis
Skin Diseases, Eczematous
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists