Nalbuphine HCL ER Tablets in Prurigo Nodularis Patients

Registry ID
EUCTR2013-005627-17
Source registry
EUCTR
Status
Completed
Phase
PHASE2
Sponsor
Trevi Therapeutics, Inc.
Start date
2015-02-05
Completion date
2016-08-11
Last update
2026-08-16

Conditions

Summary

The primary objectives of the study are: • To evaluate the effects of two doses of nalbuphine HCl ER tablets on the 7-day average daily worst itch (i.e., most severe) intensity during the last 7 days of the Fixed Dose Period (“Evaluation visit”; Visit 5) compared to baseline, as measured by daily electronic patient diary records for the Numerical Rating Scale (NRS) and reported as the proportion of patients with at least a 30% reduction in the baseline 7-day average daily worst itch NRS score • To evaluate the safety and tolerability of nalbuphine HCl ER in the study population.

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