CompletedPhase 2/3

Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

United States, Germany, Poland62 participantsStarted 2015-03

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale

Timeframe: Baseline, Week 10

Trial details

NCT IDNCT02174419

SponsorTrevi Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08

Results submitted2020-08-06

View on ClinicalTrials.gov More Prurigo Nodularis trials