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Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trevi Therapeutics
ClinicalTrials.gov Identifier:
NCT02174419
First received: June 24, 2014
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Trevi Therapeutics:

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

Enrollment: 63
Study Start Date: March 2015
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: June 24, 2014
Last Updated: September 13, 2016

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

ClinicalTrials.gov processed this record on April 28, 2017