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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

See also
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Completed NCT02174419 - Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis Phase 2/Phase 3
Recruiting NCT03540160 - Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch) Phase 3
Completed NCT02196324 - A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN) Phase 2
Recruiting NCT03576287 - Apremilast as Anti-pruritic Treatment in Patients With Prurigo Nodularis Phase 1/Phase 2
Recruiting NCT03677401 - Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis Phase 3
Completed NCT02174432 - Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis Phase 2/Phase 3
Completed NCT00507832 - Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease Phase 2
Not yet recruiting NCT00532519 - Effectiveness of the Selective Serotonin Reuptake Inhibitor,Citalopram (Cipralex), in Prurigo Nodularis N/A