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Clinical Trial Summary

To investigate the anti-pruritic efficacy and safety of Nalbuphine ER (NAL ER) tablets in Prurigo Nodularis. Subjects will be randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, subjects who received NAL ER will continue on NAL ER and subjects who received placebo will crossover to NAL ER.


Clinical Trial Description

This is a randomized, double-blinded, placebo-controlled, 2-arm study with an open label extension period following double-blind treatment, to investigate the anti-pruritic efficacy and safety of Nalbuphine ER tablets. Subjects will be randomized to NAL ER (2-week titration followed by 162 mg twice daily [BID] for 12 weeks) or matching placebo (14 weeks duration), with the primary endpoint evaluation at Week 14. During the open label extension, subjects who received NAL ER will continue on NAL ER total treatment duration 52 weeks including titration and subjects who received placebo will crossover to Nalbuphine ER Upon discontinuation of investigational product, all subjects will complete a 2-week off treatment Safety Follow-up Period, regardless of when and why the subject discontinued study treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03497975
Study type Interventional
Source Trevi Therapeutics
Contact Clinical Ops Lead
Phone 2033042499
Email clinicalops.admin@trevitherapeutics.com
Status Recruiting
Phase Phase 2/Phase 3
Start date August 7, 2018
Completion date December 2020