Study of Nalbuphine HCl ER Tablets 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; Pruritus
Intervention: nalbuphine HCl ER tablets 90 mg BID (Drug); nalbuphine HCl ER tablets 180 mg BID (Drug); Placebo tablets BID (Drug)
Phase: Phase 2/Phase 3
Status: 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 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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change from Baseline to the Evaluation Visit (Week 10) in itch on the 0-10 Numerical Rating Scale
Secondary outcome: Change from Baseline to the Evaluation Visit (Week 10) in the mean itch on the 0-10 Numerical Rating Scale
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Roberta Duncan, Phone: 203-304-2499, Email: roberta.duncan@trevitherapeutics.com
University of Münster, Münster, Germany; Recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw, Dolnoslaskie 50-368, Poland; Recruiting Ewa Tolwinska Jacek Szepietowski, Principal Investigator
Case Western Reserve University, Cleveland, Ohio 44106, United States; Recruiting Neil Korman, Principal Investigator
Temple University Hospital, Philadelphia, Pennsylvania 19140, United States; Recruiting
Additional Information
Starting date: February 2015
Last updated: July 8, 2015
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