Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

Pruritus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174419
• Other study ID #: TR03
• Secondary ID: 2013-005627-17
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2020
• Source: Trevi Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurodermatitis
• Nodularis Prurigo
• Prurigo
• Prurigo Nodularis
• Pruritus

Intervention

Drug:
• nalbuphine HCl ER tablets 90 mg BID
nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks
• nalbuphine HCl ER tablets 180 mg BID
nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
• Placebo tablets BID
Placebo tablets BID administered for 10 weeks

Locations

Country	Name	City	State
Germany	University of Münster	Münster
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu	Wroclaw	Dolnoslaskie
United States	Case Western Reserve University	Cleveland	Ohio
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Trevi Therapeutics

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale		Baseline, Week 10
Primary	Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale	The number of subjects who reported at least a 30% reduction from baseline to Week 10, expressed as a percentage of subjects in the particular arm/group who were evaluated,	Baseline, Week 10
Secondary	Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale		Baseline, Week 10