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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

Page last updated: August 23, 2015

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