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
Verified date | October 2020 |
Source | Trevi Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Trevi Therapeutics |
United States, Germany, Poland,
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 |
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