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Trial record 4 of 37 for:    nalbuphine

Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Trevi Therapeutics
ClinicalTrials.gov Identifier:
NCT02174432
First received: June 24, 2014
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
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 Intervention 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 Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Trevi Therapeutics:

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

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

Enrollment: 41
Study Start Date: August 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
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: 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 )
Study First Received: June 24, 2014
Last Updated: September 13, 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

ClinicalTrials.gov processed this record on July 27, 2017