Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis
Information source: Trevi Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prurigo Nodularis; Nodularis Prurigo; Prurigo
Intervention: nalbuphine HCl ER 90 mg BID (Drug); nalbuphine HCl ER 120 mg BID (Drug); nalbuphine HCl ER 180 mg BID (Drug)
Phase: Phase 2/Phase 3
Status: Not yet recruiting
Sponsored by: Trevi Therapeutics Official(s) and/or principal investigator(s): Thomas Sciascia, MD, Study Director, Affiliation: Trevi Therapeutics
Overall contact: Roberta Duncan, Phone: 203-304-2499, Email: roberta.duncan@trevitherapeutics.com
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.
Clinical Details
Official title: An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall incidence frequency and nature of Treatment Emergent Adverse Events (TEAEs)
Secondary outcome: Incidence, frequency and nature of Treatment Emergent Adverse Events (TEAEs) during Treatment by achieved dose
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Roberta Duncan, Phone: 203-304-2499, Email: roberta.duncan@trevitherapeutics.com
University of Münster, Münster, Germany; Not yet recruiting
Additional Information
Starting date: July 2015
Last updated: July 8, 2015
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