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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

Page last updated: August 23, 2015

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