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Open Label Extension Study of Nalbuphine HCl ER 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: NCT02174432
Recruitment Status : Active, not recruiting
First Posted : June 25, 2014
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 50 weeks.

Condition or disease Intervention/treatment Phase
Prurigo Nodularis Nodularis Prurigo Prurigo Drug: nalbuphine HCl ER 90 mg BID Drug: nalbuphine HCl ER 120 mg BID Drug: nalbuphine HCl ER 180 mg BID Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients
Study Start Date : August 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: nalbuphine HCl ER 90 mg
nalbuphine HCl ER 90mg BID
Drug: nalbuphine HCl ER 90 mg BID
nalbuphine HCl ER 90 mg BID for up to 50 weeks
Other Name: nalbuphine
Experimental: nalbuphine HCl ER 120 mg
nalbuphine HCl ER 120 mg BID
Drug: nalbuphine HCl ER 120 mg BID
nalbuphine HCl ER 120 mg BID for up to 50 weeks
Other Name: nalbuphine
Experimental: nalbuphine HCl ER 180 mg
nalbuphine HCl ER 180 mg BID
Drug: nalbuphine HCl ER 180 mg BID
nalbuphine HCl ER 180 mg BID for up to 50 weeks
Other Name: nalbuphine


Outcome Measures

Primary Outcome Measures :
  1. Overall incidence frequency and nature of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Week 50 ]

Secondary Outcome Measures :
  1. Incidence, frequency and nature of Treatment Emergent Adverse Events (TEAEs) during Treatment by achieved dose [ Time Frame: Week 4, Week 50 ]

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 completed participation in the TR03 study

Exclusion Criteria:

  • Medical condition or other factors that in the opinion of the Investigator may interfere with the conduct of the study.
  • 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): NCT02174432


Locations
Germany
University of Münster
Münster, Germany
Sponsors and Collaborators
Trevi Therapeutics
Investigators
Study Director: Thomas Sciascia, MD Trevi Therapeutics
More Information

Responsible Party: Trevi Therapeutics
ClinicalTrials.gov Identifier: NCT02174432     History of Changes
Other Study ID Numbers: TR03ext
2013-005628-41 ( EudraCT Number )
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016

Keywords provided by Trevi Therapeutics:
Itch
Chronic Itch
Nalbupine

Additional relevant MeSH terms:
Nalbuphine
Prurigo
Neurodermatitis
Skin Diseases
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