Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

Phase 2

Completed

• Conditions: Pruritus; Prurigo Nodularis; Nodularis Prurigo; Prurigo
• Interventions: Drug: nalbuphine HCl ER tablets 90 mg BID; Drug: nalbuphine HCl ER tablets 180 mg BID; Drug: Placebo tablets BID

• Registration Number: NCT02174419
• Lead Sponsor: Trevi Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Study Start: 2015-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Disposition First Submitted: 2017-05-25
• Disposition First Submitted QC: 2017-05-25
• Disposition First Posted: 2017-06-06
• Results First Submitted: 2020-08-06
• Results First Submitted QC: 2020-08-06
• Results First Posted: 2020-08-21
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nalbuphine HCl ER 90mg	nalbuphine HCl ER tablets 90 mg BID	nalbuphine HCl ER tablets 90 mg BID
nalbuphine HCl ER 180 mg	nalbuphine HCl ER tablets 180 mg BID	nalbuphine HCl ER tablets 180 mg BID
Sugar pill	Placebo tablets BID	Placebo tablets BID

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale	Baseline, Week 10

Trial Locations

Locations (4)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Münster; 🇩🇪 Münster, Germany

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu; 🇵🇱 Wroclaw, Dolnoslaskie, Poland